TABLE OF CONTENT

SL.NO. TITLE PAGE NO.

ABSTRACT

1. INTRODUCTION

2. LITERATURE REVIEW

3. RESEARCH METHODOLOGY

4. RESULTS

5. DISCUSSION

6. CONCLUSION

7. BIBLIOGRAPHY

ABSTRACT
Dr. S has seen a substantial growth in pharmaceutical industrial enterprise in Asian nation, each
by international and native businesses, throughout the previous 20 years. the bulk of
pharmaceutical merchandise are evidenced to be therapeutically competent in meeting the
requirements of the overall population. Complaints concerning the poor quality of things control
at marketplaces, on the opposite hand, are common. this analysis highlighted the first wants for
maintaining the acceptable microbiological quality of often used pharmaceutical product in
Asian nation so as to confirm overall medication user safety. info concerning the predominance
bacterium, fungi, and specific pathogens are obtained principally from recent studies on a spread
of completed pharmaceutical medicaments. All results obtained from ancient microbiological
and organic chemistry studies as reportable within the publications mentioned during this review
are strictly reviewed in relevance the prompt microorganism limits, user safety, and legislation
concerns. microorganism contamination usually decreases product quality in addition as product
stability, leading to treatment issues. moreover, active medication ingredients inside the drug is
also regenerate to less effective or with chemicals inactive forms thanks to microorganism
deterioration. microorganism and plant life contamination usually happens from raw materials,
the producing setting, or throughout the storage stage, which can jeopardize client safety. This
review study gave some convincing evidences for microorganism contamination in
pharmaceutical finished product in Asian nation and examines potential solutions to enhance
overall public health management.

A add of sixty examples were thought-about from numerous classifications of medication as well
as sweetening, pill and case and salves. Microbiological examination was done once consecutive
weakening. bactericide action of the examples not set in stone by Kirby-Bauer technique. the
whole cheap microorganism count of nine syrups, seven pill and cases and thirteen treatments
tests surpassed as so much as doable ˂102cfu/ml or cfu/gm prompt by USP (United States
Pharmacopeia) and BP (British Pharmacopeia). on the presence of specific microbes, around six,
six and 3 examples from sweetening, pill and case and treatment tests were of fine quality
severally out of twenty examples every. Some medication won nice movement towards few
microorganisms and no action by any means that to some others. because the medications have
bactericide movement, the impurities may address a couple of differing kinds of comparable
genera of microscopic organisms having a couple of systems to limit such exercises towards
them.
KEYWORDS - Pharmaceutical biological science, Product quality, client safety, Public health,
Pharmaceutical Drugs; Syrup; Ointments; Tablets; Contamination; bactericide Activity

1. INTRODUCTION
Total quality management (TQM) of pharmaceutical merchandise is thought to start with the
planning of the mill in accordance with the standards primarily specific by sensible producing
follow (GMP) and therefore the food and drug administration (FDA) and end with the
merchandise. the finished goods' final microbiological quality should match the specification
standards specific by the coupled regulative authorities, as well as the eu collection (EP), nation
collection (BP), and therefore the u. s. collection (USP). The pharmaceutical quality management
technique has been evolved into the notion of key management purpose hazard analysis.
(HACCP), a program geared toward rising the microbiological safety of finished pharmaceutical
product by developing fast technologies for police work contaminated microorganisms. In vitro
investigations indicated that a good vary of microbes could metabolise a good vary of prescribed
drugs as their substrates, leading to medication efficiency loss.

After the textile business, the pharmaceutical business is considered one in every of India's most
developed industries, contributive greatly to the country's economic success. The pharmaceutical
business dilated apace following the passage of the Drug management Ordinance in 1982. The
pharmaceutical sector in India has big quickly, notably within the last twenty years. Currently,
around 230 pharmaceutical businesses operate in India, with AN calculable total market size of
BDT seventy six five hundred million each year. solely three-d of prescribed drugs square
measure foreign, with the remainder ninety seven % factory-made in native producing facilities.
it's a big action that India will fulfil the bulk of its pharmaceutical product demands regionally.
However, complaints concerning these merchandise square measure common, however they're
not well publicized . moreover, being a developing nation with a coffee economy, the bulk of
Indians square measure unable to perpetually afford effective medical aid once ill health issues
arise. The onset of a range of diseases is additionally quite common as a results of a dense
population, deficiency disease, shy treatment of business effluents, an absence of private hygiene
awareness, a comparatively lower range of health professionals, defective medication ways, and,
most significantly, the rising issues of drug powerlessness.

Many small-scale laboratory-based studies have clearly known microbic contamination in a very
style of pharmaceutical finished product. Pharmaceutical things of poor quality will induce a
range of sicknesses and, in extreme things, will gravely injure internal organs. this may result in
considerable client discontent, which might eventually result in unfavorable money losses within
the pharmaceutical business. This review mentioned elementary} necessities for achieving the
specified quality of a drug product and additionally the standard standing of unremarkably used
pharmaceutical product in India so as to draw national attention to the present bit by bit
worsening scenario and to come up with concern in the slightest degree levels of society. The
pharmaceutical industry' challenges have additionally been mentioned to assist with the
reasoning of the talk, and a few doable concepts are given.

The u. s. Food and Drug Administration (FDA) expect that drug item be tried for its spotlessness,
character, strength, quality and solidness before it tends to be delivered to be used. so drug
approval and interaction management square measure important. In non-clean drug
arrangements, the prevalence of microorganisms is compact by the thought of fixings (natural
substances), the character of the vehicle, and therefore the thought and disposition of college
related to their taking care of as well as tablets oral dose structures don't seem to be expected to
be sterile, nevertheless sure internal control measures square measure crucial for keep the
microbic substance of those arrangements protected and satisfactory. The degree of microbic
pollution in tablets is generally compact by the microbiological nature of the start unrefined
substances, bundling materials, workers that move with the item throughout the grouping system
and therefore the creation climate yet as gear. Inability to note sensible producing follow (GMP)
at any section of creation could after influence the microbiological nature of the item. Impurities
captured into the item through the antecedently mentioned courses might not build due for an
intensive stretch of your time owing to the deadly impact applied by the various techniques used
in pill creation. essentially, medicine get ruined by starting or early trailblazer intruders of
biodegrading microorganisms, that came upon the manner for later trespassers, by dishonorable
advanced supplements, dynamic the encircling hydrogen ion concentration and creating
additional damp accessible. but drug businesses square measure filling fast in India, the character
of medicines is being compromised owing to unauthorised enterprises and cutthroat advertising.
therefore it's necessary to ascertain microbiological nature of drug things to ensure client
successfulness.

Water is crucial for grouping, restorative and center reasons, within the arrange and handling of
medicine and additional prosperity stocks and for order and medical aid reasons. Water is most
vital and loosely used within the drug business as a characteristic quality fixing, and soluble
within the regulation, dynamic drug fixing readiness, and creation of restorative things and
intermediates. Controller of the greatness of water throughout the assembly, stockpiles and
conveyance processes, yet as medicine and natural quality, may be a most vital concern. Thusly,
gift review used to determine the microbiological generality within the waters used for drug item
arrangement. a shot and commonness study was used. Sixteen examples were gathered from a
likely drug organization set at Dacca, Bangladesh. Water inspected from the creation space of
assorted medication. Customary social strategy and organic chemistry techniques were done to
count of complete microbic burden and confine the actual microorganisms from the gathered
water tests. that is what the end result found, the entire atomic number 8 overwhelming sensible
microorganism burden altogether examples tried was viewed as within as way as doable (<100
cfu/ml). Out of sixteen examples, three examples were viewed as increased with bacteria genus
spp. Our investigation discovered that just one example (test no 11) was viewed as increased
with E. coli. other than no proof of staph aureus was half-track down in any example. yet as
enterics spp. was missing altogether example. By and enormous, the momentum examination
plainly bestows a complete medicine profile of drug water and uncovers the presence of express
microbes would possibly prompt the real poisonousness and danger of the finished drug product.
Water is that the one in every of the many wares used by the drug business. it's typically used as
AN unrefined substance, fixing, and soluble within the handling, definition, and production of
drug things, dynamic drug fixings (APIs) and intermediates, and scientific chemical agent. it'd
likewise gift as AN excipient, or used for reconstitution of things, throughout union, throughout
creation of completed item, or as a cleansing specialist for flushing vessels, gear and essential
pressing materials so on. There square measure a good vary of grades of water used for drug
functions. many square measure represented in USP monographs that verify utilizes, OK
techniques for readiness, and quality credits.

Water is that the most loosely used substance, unrefined substance or starting material within the
creation, handling and arrange of drug things. it's exceptional compound properties owing to its
extremity and gas bonds. this means it will chop up, assimilate, take up or suspend numerous
mixtures. These incorporate impurities which may address perils in themselves or which may
have the choice to retort with planned item substances, conveyance concerning dangers to
successfulness. numerous grades of water quality square measure needed relying upon the needs
and course of organization of the drug things. management of the character of water throughout
the creation, reposition and dissemination processes, as well as microbiological and compound
quality, may be a main issue. Dissimilar to different item and cycle fixings, water is often drawn
from a framework for the asking and is not susceptible to testing and bunch or parcel discharge
before use. Confirmation important to meet the on would like assumption is, during this manner,
fundamental. Also, sure microbiological tests would possibly need times of brooding and,
consequently, the outcomes square measure likely to linger behind the water use. many styles of
organism would possibly multiply in water treatment elements and within the capability and
dispersion frameworks. Limiting microbic tainting by routine medical aid and reaching to fitting
lengths to forestall microbic proliferation is important. Drug water creation, reposition and
circulation frameworks have to be compelled to be planned, introduced, appointed, approved and
well-kept with to ensure the solid creation of water of a fitting quality. These frameworks ought
not be worked past their planned limit. Water have to be compelled to be created, place away and
sent in a very manner that forestalls unsuitable microbic, compound or actual pollution.

Because of its criticality in drug creation, microbiological management of water is important.

Since water is at any purpose gift, every grade of drug water may be a doable wellspring of
microbiological pollution, notably once not fittingly controlled. management is not only
concerning quantities of microorganisms recuperated through bio-trouble testing for
microbiologists moreover got to comprehend the styles of living beings gift within water. this is
often to go looking for changes to patterns and to understand within the event that they're signs
of extra important problems (like bio-films) or on the opposite hand forward they gift a singular
gamble to things (and after to patients).

Despite the very fact that the majority drug water frameworks square measure controlled,
microorganisms can a number of the time be accessible in low numbers. the necessity for
microbiologists to think about the consistent and dynamic samples of microorganisms found in
water frameworks square measure fluctuated.

Control of the microbiological nature of drug water may be a high would like. many styles of
organism would possibly multiply in water treatment elements and within the capability and
conveyance frameworks. Limiting microbic pollution by legitimate arrange of the framework,
occasional sterilization and by reaching to correct lengths to forestall microbic proliferation is
crucial.
Water used for drug functions will be divided into 2 general sorts: mass waters, that square
measure often created close wherever they're utilized; and bundled waters, that square measure
delivered, bundled, and change to safeguard microbic quality throughout their bundled time span
of usability. There square measure many explicit styles of bundled waters, variable in their
appointed applications, bundling restrictions, and different quality credits. Decontaminated
Water is employed as AN excipient within the development of no canal arrangements and in
different drug applications, like cleansing of specific hardware and nonparental item contact
elements. Except if typically indicated, refined Water is likewise to be used for all tests and
measures.

Numerous ventures expertise the sick effects of the microbic pollution of ultrapure water (UPW).
These incorporate the drug, food, and refreshment businesses. The presence of even a solitary
microorganism cell or doubtless the results of cell debasement, will seriously consider
concerning nature of the ultimate outcome. during this manner, appropriate support of drug water
the executives framework is prime to ensure the tip result successfulness and non-harmfulness.
while not a doubt in Bangla Desh, microbiological pollution of various waters is extraordinarily
traditional. Plus, the drug things are viewed as debased with a range of microorganisms;
notwithstanding, the water used for the grouping reason has not been cleft at now.

There don't seem to be several distributed references regarding the conventional miniature
verdure in handled water and, astonishingly, less that relate to the drug business. the dearth of
necessary information during this regard, the present review endeavored to determine the
microbiological commonness within the waters used for drug item readiness and to segregate the
infective organic entities, for instance, staph aureus, E.coli, enterics and P. aeruginisa so on from
the gathered filtered water tests by utilizing normal tests. In end, that is what we tend to presume,
the entire atomic number 8 overwhelming cheap microorganism burden altogether samples of
water used in drug business for grouping of medication and medications was viewed as within as
way as doable (i.e.,<100 cfu/ml). because the drug ventures square measure developing to their
greatness in Bangla Desh, the unrefined elements for grouping, nevertheless to boot the
microbiological qualities of the waters have to be compelled to be thought-about for the finished
item security, that so, would achieve success normally successfulness the executives. Routine
observant of drug water is consequently advised.
Microbial pollution of medicine has been a unending issue for specialists yet as drug
manufacturers round the world. It will cause the deterioration of the equation by separating
dynamic fixings and excipients, influencing the strength, solidness and viability of the
medication. Moreover, the presence of huge quantities of microbes represents a real
successfulness danger to shoppers, notably the people that square measure as of currently sick or
in a very debilitated state. many instances of unwellness owing to contaminated medicine were
accounted for in writing.

Normal drug impurities incorporate microscopic organisms, wherever tainting with gram-
positive microorganisms ensnares human mediation as a big justification behind item
befoulment, whereas the presence of gram-negative microbes proposes absence of cycle
management in drug conditions, notably as well as water frameworks and unrefined elements.
gram-negative poles square measure thought-about the foremost typically found microorganism
disconnects in non-sterile medicine, paying very little mind to geologic space or time.

Regular normal microbiological ways square measure presently used for the conventional testing
of drug things and recognizable proof of drug microorganism pollutants, as well as customary
collection techniques, yet as improved, financially accessible organic chemistry take a look at
packs, for instance, the API framework. As of late, nevertheless, sub-atomic advances have by
all odds compact the sector of drug microbic science, giving quick quantitative yet as subjective
information on microorganisms gift in a very given drug take a look at. The 16S rRNA quality is
usually often used for ordered functions.

The target of this study was to differentiate microorganism pollutants, separated from numerous
medicine utilizing ancient organic chemistry ways and therefore the API recognizable proof
framework. microorganism secludes showing unsure or inconsistent outcomes were to boot
exposed to enzyme chain response (PCR)- primarily based techniques for characteristic proof
utilizing either widespread or species-explicit groundwork matches.

Additionally, this study pointed toward staring at between normal organic chemistry techniques
and PCR-based measures within the recognition of collection microorganism markers in
incorrectly spotted drug tests as for time, value and cutoff of identification. microbic tainting of
medicine would possibly emerge throughout grouping, reposition or use by the buyer, and may
eventually cause many annoying results. In Egypt, microbiological labs follow the USP and BP
proposals for testing the presence/heap of microbic impurities in non-sterile measuring structures
and dietary enhancements.

In the current review, completely different organic chemistry (ordinary and API) and sub-atomic
(PCR-based) techniques were used for the characteristic proof of assorted microorganism
pollutants detached from differing types of medicine (counting drug arrangements, restorative
arrangements, home big things and unrefined components). each of those ways were then
contrasted with respect with the recovery and characteristic proof of chosen microorganism
impurities.

The microorganism foreign substances were disengaged from thirty one out of eighty five pre-
utilized drug things tried (36.5 %). Likewise, it absolutely was accounted for before that half the
nonsterile medicine things tried were intensely tainted. Then again, bell et al. declared heaps of
lower befoulment of the tried corrective things (10.6 %). Pre-utilized things were picked for this
review, to expand the chance of pursuit down pollutants. Foreign substances confined from drug
arrangements, tending product and unrefined elements were for the foremost half gram-positive
(~90.5 %, nineteen out of twenty one pollutants), whereas those segregated from home big things
were for the foremost half gram-negative (90 nothing, nine out of ten impurities). In concurrence
with this last choice finding, Abba et al. disclosed that forty six.67 you look after home big cures
tried were tainted with S. typhi, 19.33 you tired of enterobacteria spp. moreover, 58.67 you tired
of E. coli. The noticed befoulment of home big tea sacks during this review with Gram-
pessimistic microbes might be owing to any of the concomitant reasons: (I) unacceptable
designing techniques; (ii) debased materials and gear; yet as (iii) unadvised treatment of
unrefined elements by contaminated workers throughout handling. For natural arrangements to
stay up with very best quality, successfulness and viability, fabricating organizations ought to
guarantee the foremost important level of cleanliness throughout grouping, to ensure the smallest
amount conceivable degree of infective organic entities in their last home big things. Then again,
occurrences of microbic befoulment of tending product square measure typically elaborated. this
might be attributable to deficient safeguarding of tending product or the employment of
nonchurchgoing things by the final population, that so will prompt microbic befoulment that
favors development and multiplication of skin microorganisms upon use. In 2003, novelist and
associates declared that microbic befoulment was known in sure brands of restorative creams,
wherever the foremost widely known microorganism foreign substances found were staph spp.
what is additional, true bacteria spp., a finding that is like our own within the in progress review.
Then again, a brand new report directed on non-clean oral measurements structures ascertained
that toxins were typically gram-negative eubacterium.

Contrasted with tending product and drug arrangements, unrefined substances showed a better
level of befoulment (58.8 %), presumptively owing to the absence of compelling artificial
conservation, wherever 100% of the pollutants wherever gram-positive microscopic organisms.
Our outcomes square measure in concurrence with those of First State Clerk et al. WHO
elaborated that the majority of impurities secluded from gelatin removes had an area with people
from the variability true bacteria.

In the in progress review, thirty-nine you look after the toxins were distinguished as true bacteria
spp., most of that were disengaged from non-sterile dose structures. primarily, in a very new
report from the year 2010, Mucocele and Moabite elaborated that the majority of microbic
foreign substances segregated from non-sterile medicine were true bacteria spp., Since simply
twenty six.8 % of the secluded pollutants (6 gram-positive and five gram-negative disengages)
were convincingly distinguished utilizing each regular techniques and therefore the API
Staph/API 20E framework, sub-atomic ID was thought-about important for the leftover toxins.
Likewise, additional characteristic proof of true bacteria pollutants to their careful species wasn't
doable by standard organic chemistry tests, since people from the family true bacteria show a
good scope of physiological flexibility, allowing them to measure in just about each common
home ground. They thence needed additional characteristic proof utilizing PCR-based ways
utilizing species-explicit preliminary matches. Like ancient organic chemistry experimental
outcomes, disconnects 20A and fifty two showed a PCR item at the relating band size (174 bp),
and were during this manner distinguished as S. epidermidis. It have to be compelled to be
noticed that detach 20A was mistakenly distinguished as S. auricularis utilizing the API
staphylococcus pack. Despite the very fact that S. auricularis is biochemically like S.
epidermidis, the previous is urease-negative. This noticed inconsistency within the organic
chemistry ID consequences of disengage 20A most presumptively emerged owing to the manner
that it gave a positive enzyme take a look at utilizing the regular technique, whereas it absolutely
was accounted for as urease-negative utilizing the API staphylococcus unit. S. chromogens
likewise includes a comparable organic chemistry profile to S. epidermidis; be that because it
could, detach wasn't recognized as S. chromogens, since the last choice produces yellow-
pigmented settlements when refined on supplement agar, not in the slightest degree like insulate.

Some ID plans do not represent constitution varieties among strains having an area with similar
animal varieties. for instance, S. saprophyticus is recorded in a very few recognizable proof plans
as water pill non-maturing, albeit in our review, one mannitol-fermenter, detach 16B, was
definitively distinguished as S. saprophyticus by phyletic examination. Then again, the larger a
part of S. warner strains square measure proverbial to be mannitol-fermenters. This reality led to
the incorrect ID of the S. warner disengage twenty two, a water pill non-ferment or, novobiocin-
delicate and urease-positive coccus detach, as S. epidermidis by standard organic chemistry
techniques. By and by, each one of the 5 S. epidermidis disengages (16A, 20A, 20B, 52, 57A)
were indisputably distinguished in and of itself by ancient organic chemistry tests, visible of their
water pill non-aging, coagulase-and DNA-negative, novobiocin-delicate and urease-positive
qualities.

In this review, each organic chemistry and PCR-based techniques were used to acknowledge
microorganism markers in deceptively tainted drug grade aldohexose powder, to distinction each
ID ways with deference with time and value. Improvement of the PCR response conditions for
the various groundwork matches (toughening temperature: 55°C; augmentation time: forty five
s) was exhausted the PCR-based characteristic proof technique, making an attempt to save lots of
time. . The PCR response conditions improved in different comparative examinations contrasted,
presumptively relying upon the groundwork matches used and therefore the size of the
amplicons created apart from the sort of polymer enzyme used for improvement.

The moderately extended timespan expected by organic chemistry techniques for ID was like
completely different examinations. we tend to after reasoned that the quality USP methodology,
that depends mainly on organic chemistry ways for the ID of microorganism pointers, was each
tedious and work escalated. It likewise needs completely different strides for the event and
segregation of pure microorganism societies preceding their recognizable proof, conveyance
concerning deferring the arrival of natural substances/drug things. Then again, the somewhat
transient timeframe necessary to guide a PCR examine was as per past investigations. On
assessing the MDL for each recognizable proof technique, the MDL of E. coli utilizing the PCR
examine was below that noticed utilizing standard ways. primarily, Juan Ramon Jimenez et al.
determined a MDL of 104 CFU/ml for enterics spp. by a PCR-based technique, whereas when a
year, a better MDL (105 CFU/ml) for E. coli, P. aeruginosa and S. aureus was accounted for
[40]. On the opposite hand, Samedi et al. disclosed a far lower MDL of 102 CFU/ml. All the
additional as lately, Faraj Nia et al. had the choice to spot microbic tainting at a degree of below
ten CFU/ml or gram of AN item, utilizing a multiplex PCR examine. None of the last choice
reads up determined a MDL for normal tests. The holder of AN grouping approval should
medications to ensure that they're sensible for his or her expected use, change to the stipulations
of the selling Authorization and do not place patients in peril owing to lacking successfulness,
quality or viability. To accomplish the standard goal, it's necessary to regulate all phases of
medicines, that covers all matters, that {separately|individually|singly|severally|one by one|on
AN individual basis} or bushed all impact the character of an item, as well as unrefined
substances, the grouping system and therefore the assessment of completed item. one in every of
management stages is that the appraisal of microbiological nature of restorative things (Ty ski,
2011; Guide to nice grouping follow for therapeutic things, 2013). sequent versions of the eu
formulary (EP) square measure valuable devices within the quality analysis, as they kicked off
the microbiological determinations, measures and therefore the ways for microbic assessment of
non-sterile things.

The techniques used and results nonheritable have to be compelled to accept as true with the
particulars and rules framed within the appropriate formulary. Testing, that is performed on each
natural substances and completed things, includes microbic identification tests for all out
vigorous microbic counts (TAMC) and absolute yeast and form counts (TYMC), nevertheless
tests for the concomitant determined miniature organic entities: staph aureus, bacteria genus
aeruginosa, E. coli, enterics spp., Candida albicans.

Microbiological appraisal of non-sterile things is very relevant considering the manner that
microbic befoulment will decrease or try to get rid of the restorative impact of medicines or
cause drug-incited contaminations. Microorganisms introduced in medicine not simply makes
them parlous from the irresistible outlook, moreover could amendment the compound, physical
and organoleptic properties of the medications or amendment the things in dynamic fixings.
Moreover, microorganisms will amendment medicine over utterly to toxic things.
The presence of even a coffee degree of infective microorganisms, additional important levels of
pioneering microbes or microorganism harmful metabolites, that endure even when the ending of
the essential impurities may result the item ineffectual.

Not simply the presence of microorganisms, that cause unfortunate microorganism diseases is
unsafe, nevertheless additionally the presence of metabolites/poisons would possibly cause
terrible aspect effects in spite of whether or not they square measure remembered for modest
quantities. a little of those poison - connected infections incorporate play of the bowels, intense
inflammatory disease or abdomen torment. aspect effects shift from light pain to abdomen
passing, contingent upon the singular aversion to poison, live of eaten poison and casualty
general successfulness. Extreme contaminations in upset people are dealt out to enteric bacteria
spp., and true bacteria spp. many medical clinics gained and a few short term procured
contaminations, particularly respiratory illness, square measure likewise relegated to enteric
bacteria spp.

Reports of diseases go off by drug pollution of microbic starting prompted the muse, within the
final a part of the 20th hundred years, of AN exceptional board of trustees at the International
Pharmaceutical Federation (FIP) that was entrusted with drawing up rules managing drug
creation. The works finished within the advancement of fine producing follow (GMP) rules.
they're not a static plan nevertheless rather a powerfully making framework which allows
additional improvement of the creation interaction. The GMP standards were familiar with
guarantee finest drug things and shield patients' life and successfulness.

In addition, microbiological spotlessness measures were arranged out and therefore the
requirement for last microbiological management was given. Likewise, a bunch of rules was
projected to direct the topic of maintaining with natural cleanliness, keeping doable pollutants
from deed section to grouping destinations and guaranteeing legitimate capability conditions for
unrefined substances used afoot cycles (Regulation of the Minister of Health, 2008, 2009).
Considering the noticed fast development of the drug space, rules of lead were suggested for the
grouping system to ensure that correct nature of completed things is well-kept with. the
foundations square measure ordered pretty much as good producing follow code. below the Act
on Pharmaceutical Law gave on vi Sep 2001, GPM alludes to works on "guaranteeing that the
restorative things square measure made-up and controlled enough to their expected use and in
consistence with the wants remembered for his or her determinations and reports comprising a
premise to offer a license for promoting approval of restorative item" (Act on Pharmaceutical
Law, 2001).

The point of review was to interrupt down the outcomes nonheritable from microbiological
virtue trial of non-sterile medications by numerous drug sides set within the region of European
nation. the purpose of study was to introduce varieties of irregularities profile happening within
the focused on gatherings of medicines. The nonheritable outcomes that square measure
introduced below will additional develop the creation quality in drug plants, illuminate/mindful
concerning the requirement of microbiological management creation cycle of every medications
series and consequently work on the successfulness and nature of meds.

1.1. Microorganisms getting into pharmaceutical goods

Regardless of the very reality that the prohibitive code oversees all periods of drug item make,
bodies; microorganism entrance into the creating stream with extreme market dissemination isn't
unfathomable. escherichia (E. coli), enterics spp., microbes sort aeruginosa (P. aeruginosa),
staphylococci aureus (S. aureus), Burkholder spp., Alcaligenes spp., Flavobacterium spp.,
Chromocyte spp., sort Serratia spp., Bacillus subtilis, Bac in like manner as timeserving
microorganism microbes. Such polluting microorganisms have the adaptability to adjust with
almost no natural cycle needs and fill in each mass and completed item.

Pollutants could likewise be liberated from natural substances, delivering apparatus, the
gathering environmental elements, the people playacting the activity, or the instrumentality into
that it's at last pressed and fixed. Low quality unrefined components not exclusively debase the
top item's quality and timeframe of realistic usability, but they will conjointly add to general
microorganism tainting among the gathering plant. Temperature, proportion, differential gaseous
tensions, air disturbance, and hence the remaining of high strength molecule air channels could
all impact microorganism section into drug product and reason. in addition, ill-advised
cleanliness support all through fabricate, bundling, dissemination, and capacity has been
associated with drug crumbling.

Drug acknowledgment rules should be strictly complied with as per the endorsed guidelines
given by the BP, USP, or EP. for instance, the by and large vigorous microorganism count
(TAMC) in oral non-watery details should be however 103 CFU/g, and in this way the complete
yeast hill count (TYMC) ought not be very 102 CFU/g. Likewise, a definitive result of the oral
double compound readiness shouldn't surpass the ten2 CFU/mL limit for TAMC and 10
CFU/mL limit for TYMC. each styles of oral arrangements ought to be liberated from E. coli.
The TAMC for body part arrangements ought not be bigger than 103 CFU/mL, and in this
manner the TYMC ought not be bigger than 102 CFU/mL. the fitting microbiological limit for a
couple of explicit oral arrangements made of regular unrefined components has been projected to
be 104 CFU/mL for TAMC and 102 CFU/mL for TYMC, and in this way the item should be
liberated from enterics spp., E. coli, and S. aureus. flavorer drugs have a microbiological
breaking point of up to 105 CFU/mL for TAMC and 104 CFU/mL for TYMC, and won't
embrace E. coli (no very 102 CFU/mL) or enterics spp. The microbiological furthest reaches of
ten2 CFU/mL for TAMC and 10 CFU/mL for TYMC is wide acknowledged for all non-sterile
arrangements liberated from S. aureus and P. aeruginosa.

1.2. Drug predominance confirmation and contagious prevalence control

QA is illustrated as an administration framework that has each of the methodology expected to

confirm that a drug item methodicallly sticks to a predefined depiction of the directed quality
(Figure 1). In this way, quality affirmation (QA) typify definition style, examination and
advancement (R&D), GMP, QC, and overseeing market grumblings. Drug inward control
incorporates assessing the microbiological load inside the delivering setting, hardware, laborers,
mass materials, in-process reviews, and evaluating explicit microorganisms in finished item
before soothing them to the market. The underlying stage in microbiological the executives is
that the quality examination of unrefined components and water utilized in creating (Figure 1).
In-process perception of a drug item uncovers in the event that the product quality was kept up
with at the reasonable levels all through creation and cycle. the completed item tests, that
encapsulate microbiological, natural science, clinical science, and atomic techniques, show
assuming the release particulars were happy appropriately.
1.3. The emergence of drug-resistant microorganisms presents a threat to the
pharmaceutical sector.

Most anti-infection agents ar made for a huge scope by microorganism, that ar then, at that point,
recover into anti-microbials maturation is that the technique for changing unrefined substances
into anti-microbials, that after goes through the coupled downstream fountains for anti-microbial
recuperation. Anti-toxins have for some time been utilized as powerful disease medicines. Be
that as it may, inside the most recent couple of years a considerable lot of those medication are
identified to be less compelling clinically on the grounds that the morbific microorganism ar bit
by bit transforming into safe against them. This has been one in everything about principal
genuine general wellbeing emergencies inside the globe, with the possibility of mass mortality
through simple diseases and treatment-related outcomes. Methicillin-safe S. aureus, vancomycin-
safe S. aureus, coagulase-negative staphylococci, glycopeptides middle delicate S. aureus,
vancomycin-safe Enterococcus species, anti-microbial medication genuine microscopic
organisms pneumoniae, broadened range - lactamase producing microorganism, and
carbapenem-safe microorganism ar all normal. Multidrug-safe Pseudomonas aeruginosa,
Stenotrophomonas melophilia, and Acinetobacter Baumann, likewise on the grounds that the
impenetrable bacilli genuine microbes TB and genuine microorganisms avium progressed, have
for some time been perceived as genuine wellbeing takes a chance with globally.Bacterial
protection from standard antimicrobial medicines will arise as a consequences of body
irregularities, normal transformation, consideration body or hopping quality trade of plasmids
containing drug-safe qualities, or maybe even exchange of qualities converting into drug-
obstruction characteristics. As displayed in emerging nations with less very much read
populaces, similar to Asian country, erroneous self-prescription, irregular and unreasonable
utilization of non-recommended anti-infection agents, and unpredictable utilization of anti-
microbials in creature taking care of ar key supporters of rising microorganism obstruction.

Table1\

1.3.1. The start of R&D and the prospects of India's pharmaceutical businesses

To combat the pathological state caused by the emergence of drug-resistant bacterium, new drug
molecules should be generated through the implementation of acceptable R&D ways.
international pharmaceutical businesses square measure currently engaged on making and
developing innovative medications and tailored drug delivery technologies for improved
treatment of existing and recently rising diseases. Biopharmaceutical analysis businesses within
the us invested with around $48.5 billion USD in new R&D in 2012, and also the office licensed
forty four new medicines. The pharmaceutical industry's R&D stage is in its infancy in Asian
country.

However, analysis conducted by a number of India's leading pharmaceutical firms is critical. for
instance, one in all India's largest autochthonal pharmaceutical businesses is currently that
specialize in vaccinum development. It ought to even be noted that Asian country exports a range
of healthful things to alternative countries.

Vietnam, Singapore, Myanmar, Bhutan, Nepal, Sri Lanka, Pakistan, Yemen, Oman, Thailand,
and alternative Central Asian and African nations the state is additionally broadening its business
in European countries[10]. In 2003, the export was roughly seventeen million USD, that climbed
to thirty million USD by 2009. (Figure 2). numerous business analysts and professionals
anticipate that this upward tendency can continue within the future years.

1.3.2. Current situation of pharmaceutical product quality in India: in vitro analysis

Unsatisfactory microbiological presence has been found in oral liquid medications, lotions, and
ointments purchased from native pharmacies. Delhi, Republic of India (Table 1). Antacid liquid
medicines, for instance, were shown to be extensively contaminated with cocci spp. S. aureus
was found in cough sweetening likewise as multivitamin pill sweetening. cocci aureus, enteric
bacteria spp., bacteria genus spp., and E. coli were found in medicine oral liquid medicine.
microorganism pathogens like cocci spp., Bacilli spp., E. coli, and enteric bacteria spp. were
discovered in eye and ear ointments. In five hundredth of the instances, topical treatments
(creams and ointments) were found to be contaminated, with microorganism masses surpassing
the USP and BP limits (102 CFU/g). There was a high prevalence of cocci spp. and bacteria
genus spp. in these samples. bacterium and plant were found all told oral sweetening and
suspension samples, with 23.7 % of sweetening and ninety two.8 % of suspension samples
higher than the USP or BP microbiological limit. what is more, the cosmetic samples examined
were discovered to be haunted by a range of bacterium and fungi. In spite of the method that the
microbic examination of drug things in several exploration analysis centers has been done on a
restricted scale, it's heretofore a legitimate mark of the standard issue of the drug things
sometimes accessible in Republic of India. later, it's deeply basic to form preventive advances
and elementary moves to alleviate the continuing worries. the subsequent area unit some of the
proposals which will be applied much.

Cooperative specialised and analysis endeavors by the universities and exploration associations
in Republic of India, right off the bat, will build the quantity of the evaluated drug things
remarkably. Examination of larger variety of things by larger variety of scientists/experts may be
performed within a short amount. this may not simply improve what quantity proof with
relevance the character of the things, nonetheless additionally can offer motivation on a public
level to energise this kind of concentrate in future.

Also, rigid body activities have to be compelled to be used by the Republic of India government
to ensure that the GMP and also the TQM area unit overall exactly preserved with in all of the
neighborhood drug enterprises of the country. Customary assessment of the creation climate of
the ventures have to be compelled to be performed by government workers to additional develop
the final creation quality. The drug creation and premises, significantly of the recently planned
medicine ought to follow the bureau requirement, that ought to be supported formally. Another
vital purpose is to contemplate that despite an intensive adherence to GMP and TQM throughout
collecting and bundling systems, it's not adequate to warrant that a medicine will not ever flop
below the severe maltreatments of real conditions. a correct QA framework ought to incorporate
the quality act of checking the getting used execution and for responsive the patron objections.
Thirdly, microbial tainting of items is dependably conceivable even in the wake of following
every one of the guidelines, potentially due to the microbiological lopsidedness in the creation
climate which might be un-taken note. In addition, ill-advised dealing with and capacity of the
items in the neighborhood stores may likewise credit to the item quality corruption assuming that
there is no issue in the creation level. All things considered, individuals in the stores answerable
for taking care of and keeping the items ought to be appropriately prepared and taught prior to
being selected for the particular obligations and obligations. It ought to be made required for the
neighborhood storekeepers to guarantee that the staff is enough prepared to keep up with the
ideal states of the put away items.

At long last, more interior and outside subsidizing ought to be given to advance the R&D phases
of the nearby drug enterprises to foster novel and more viable medications against the medication
safe pathogenic microorganisms.
2. LITERTURE REVIEW

Valagaleti and colleagues, 2003, The drug development method begins with the invention of a
drug molecule that has incontestible therapeutic effectivity in combating, dominant, preventing,
or activity diseases. The synthesis and characterization of such compounds, additionally called
active pharmaceutical ingredients (APIs), similarly as their analysis to supply preliminary safety
and therapeutic effectiveness knowledge, square measure needed before distinguishing drug
candidates for additional intensive analysis.

Pajander et al. (2013), Akseli et al. (2008), Varghese associate degreed Cetinkaya (2007) the
advice suggests that candidates regard the opposite enantiomorph as an impurity and style
identification tests capable of differentiating each enantiomers and also the racemic combination.
it's necessary to present instruments for effective internal control systems that guarantee safe and
proper production operations. Inadequate in-process management, on the opposite hand, might
end in merchandise with surface imperfections. moreover, unidentified foreign matter particles
could also be gift within the completed product. to forestall further contamination, the foreign
item should be detected and its supply should be determined. As a result, associate degreealytical
techniques should be wont to change an economical detection and identification procedure of
foreign materials from indefinite quantity forms.

Pifferi and colleagues, 1999, Marketed medications might are available in a range of dose
formats. The route of administration is wont to classify formulation. Pharmaceutical
development data offers the scientific basis for kindulation development similarly as reasoning
for associate degree applicable dose form. regulative recommendation solely provides restricted
specifics on the wants for knowledge sets connected with pharmaceutical development (US
Department of Health, 2003), however additional intensive data is provided for excipient toxicity
assessment (U.S Department of Health, 2002).
Wirth et al., 1998; Bryn et al., 2001; Serajuddin et al., 1999 Excipients frame the bulk of solid
indefinite quantity forms and operate as diluents to permit the producing of properly sized pills
similarly as coatings to guard the tablet from unwanted organoleptic options of the healthful part.
once the drug material is reactive, solid state reactions within the indefinite quantity kind would
possibly occur, which might be increased by physical and chemical interactions with excipients.
In alternative circumstances, excipients might not act with chemicals however instead increase
drug ingredient breakdown. Primary and secondary amines, as an example, will react with
disaccharide, glucose, and malt sugar to form glucosamines.

Rahman and colleagues, 2005, The origins of the titrimetric methodology of study could also be
copied back to the center of the eighteenth century. Gay–Loussac created the volumetrical
technique in 1835, that LED to the event of the word volumetric analysis. though the assay
technique is kind of ancient, there square measure signs of modernization, like the unfold of non-
aqueous volumetric analysis ways, the enlargement of the sphere of application of titrimetric
ways to (very) weak acids and bases, and potentiometric finish purpose detection, that improves
methodology exactitude. Titrimetric approaches are incontestible to be effective in kinetic
measurements, that square measure then wont to verify reaction rates, with the creation of useful
cluster analysis processes. There square measure many blessings to using these approaches, as
well as time and labor savings, high accuracy, and also the elimination of the necessity for
reference standards. angiotensin converting enzyme inhibitor concentrations were antecedently
determined victimisation titrimetric techniques.
3. RESEARCH METHODLOGY

3.1 Materials and Procedures

3.1.1Sample Gathering and Preparation

Seventy samples were obtained from varied sorts of product (Syrup-20, pill & Capsule-20,
Ointment-20). pharmaceutical stores exploitation established microbiological and organic
chemistry procedures, all samples were examined to work out the microorganism and fungous
burden, still because the presence of specific unhealthful microorganism and actinomycetes.

3.1.2. Sample Dilution

All pharmaceutical samples were serially diluted severally for homogenized samples. Then, ten
issue serial dilutions were created by transferring one milli metric capacity unit of the first
completely homogenized material to a tube containing nine milli liters of sterile traditional saline
and repetition the method till a 10-5 dilution was made. every tube was tagged with the type of
sample and therefore the dilution range.

3.1.3. Count of Total Viable microorganism and fungous Populations

An aliquot of zero.1 mil of every resolution from dilution one0-2 was placed onto organic
process agar (NA) and seacoast grape sugar agar (SDA) plates to count total viable count (TVC)
and total fungous load. The plates were incubated for twenty-four hours at 37°C (NA plates) and
forty eight to seventy two hours at 25°C (SDA plates).

3.1.4. enumeration Specific Pathogens

0.1 mil of suspension was placed over MacConkey agar, diuretic salt agar (MSA), cationic
detergent agar, and SS agar medium for the sequent enumeration of E. coli, enteric bacteria spp.,
staph spp., bacteria genus spp., enterobacteria spp., and enterics spp. All of the plates were
incubated for twenty-four hours at 37oC. The emergence of bluish-black colonies with a
inexperienced tinny shininess on eosin-methylene blue (EMB) agar showed the presence of E.
coli. For the last word identification of the isolates, corroboratory organic chemistry assays were
performed.

3.1.5. Antimicrobial Activity of Samples Determination

The samples' antibacterial drug activity resolve exploitation the agar well diffusion technique.
The sample suspension was applied on to the Mueller-Hinton agar medium. Initially, unhealthful
microorganism suspensions with a murkiness of zero.5 McFarland were used (Pseudomonas
eubacterium enterobacteria enteric bacteria staph aureus, Proteus spp., Enterobacter spp.,
Acinetobacter spp.) were inoculated separately over the Mueller-Hinton agar media exploitation
cotton swabs, and one hundred l of the drug sample resolution was inserted into the wells shaped
within the agar plates exploitation sterilized cork borer with a positive management.
(antidepressant disc) and a negative management (normal saline). The presence of a clean zone
close the wells stuffed with sample resolution showed that the tested samples were antibacterial
drug.
4. RESULTS

The recent investigation found a great deal of heterotrophic microorganism growth at intervals
the medicative things. the entire microorganism count in sweetener, pill, and capsule samples
varied from one.0102 cfu/unit to nine.2104 cfu/unit (Tables a pair of & 3). Ointment samples
exhibited total aerobic bacterium growth starting from one.8102 cfu/gm in sample eighteen to
eight.9104 cfu/gm (Table 4) in samples six and fourteen. Aerobic bacterium were found in raw
materials starting from a pair of.4102 cfu/gm in magnesium oxide milk to a pair of.7104 cfu/gm
in atomic number 12 chloride (Table5). escherichia wasn't found in any of the seventy samples
tested. staph aureus (highest count in pill & capsule samples), genus Pseudomonas spp. (highest
count in sweetener samples additionally as pill & capsule samples), and enterics spp. were the
foremost common contaminants discovered altogether of the things (highest in sample four of
pill and capsule). though the raw materials examined during this investigation were afar from
enterics spp., many final merchandise like sweetener, pill and capsule, and ointments were
discovered to be contaminated with enterics spp. Despite having the next overall microorganism
count, sweetener samples twelve and twenty were afar from specific species. as compared to
different samples, six samples out of twenty were determined to be in an appropriate vary for
shopper safety. Samples 6, 7, 8, 9, 10, and eighteen of pill and capsule were found to be at
intervals the suitable microbiological limit [16,29]. solely 3 of the ointment samples were of high
grade (Tables six & 7).
All twenty sweetening samples shown medication activity against a spread of microorganism
strains. the common inhibition zone was fifteen metric linear unit. the best activity was shown
against true bacteria spp. (Sample size 8-21 metric linear unit, sample size enterobacteria spp. (9-
20 mm, sample 11-25 metric linear unit) and (sample 7-23 mm, sample 16-20 mm). Similar
medication activity against totally different isolates was seen with sweetening samples.
The pill and capsule samples incontestible all-time low range of medicinal drug activity against
enterics spp., equally just like the sweetener samples. For Proteus spp., sample a pair of had the
very best power (23 mm). Such Samples half-dozen and fifteen had robust activity against
bacteria genus spp. (23 metric linear unit and twenty metric linear unit, respectively), sample
sixteen had high activity against enterics spp. (24 mm), and sample twenty had smart activity
against true bacteria app (19 mm).
Salmonella spp. and Pseudomonas spp. had the lowest antibacterial activity. Better on average
5. DISCUSSION

The goal of this experiment was to seek out microorganisms in final pharmaceutical product like
sweetener, pill and capsule, ointment, raw materials, and so on. it is a shame that each one of the
things were infected with numerous forms of germs and plant. the general aerobic
microorganism load was but 104 cfu/gm or cfu/ml, whereas the whole plant count was but one
zero one cfu/gm or cfu/ml. except for these, enteric bacteria spp., Pseudomonas spp.,
staphylococci aureus, and even enterobacteria spp. were varied, that weren't expected in
alternative samples like ointments. 9 sweetener samples exceeded the USP (United States
Pharmacopeia) commonplace of total aerobic microorganism count of 102 cfu/ml, rendering this
stuff unsuitable for patient usage. per USP, topical ointments and binary compound preparations
for oral use (syrups) should not embrace Pseudomonas spp. or staphylococci aureus. The load of
enteric bacteria spp. should not exceed 102 cfu/gm, that has already been surpassed in multiple
samples (3 sweetener samples, vi pill & capsule samples). The load of enteric bacteria spp. in
non-aqueous oral medications (tablets and capsules) was over the permissible limit all told of
those samples. the standard of the things is crucial if they're to be used by patients. as a result of
the medicative product below review weren't sterile, they'll embrace germs, however solely at
intervals an exact vary. what is more, there'll be no morbific specific microorganism count, that
was antecedently discovered to be gift in check samples. as a result of medications area unit
given to patients UN agency area unit already sick Associate in Nursingd in an immune
restrictive state as a results of their malady, administering tainted prescribed drugs to them could
cause substantial damage as compared to healthy folks. within the industrial sector, samples will
get contaminated during a form of ways in which, together with handling of raw materials, water,
and process of waste.

Antibacterial activity against staphylococci aureus, Proteus spp., and enteric bacteria spp. was
incontestible product, filthy machinery, contaminated packing materials, packaging and material
storage conditions, and then forth. to shield people's safety, the supply of contamination related
to such prescribed drugs should be known. Workers' hygiene within the mix and production
areas is one in every of the foremost important problems to control within the industrial sector.

Aside from microbiological testing, syrup, pill, capsule, and ointment samples were tested for
bactericide effectiveness against numerous laboratory freeze dried harmful microorganism
isolates. Some samples had no bactericide action the least bit, whereas others had sturdy
bactericide activity up to twenty four millimeter. true bacteria species and enterobacteria spp.
had the most effective results with the medications, whereas Enterobacter spp. had the worst. as a
result of true bacteria spp. and enterobacteria spp. each embrace harmful species, they performed
well by having a bigger zone of inhibition. bactericide activity against alternative microorganism
was conjointly discovered to get on the order of fifteen millimeter. as a result of all oral
medications (syrup, pill, and capsule) have some bactericide action, the products themselves area
unit contaminated with microorganism that belong to a similar genera however have distinct
species, that the presence of microorganism and therefore the inhibiting microorganism area unit
influenced otherwise by these medication. a similar situation holds true for ointments.
Contamination is a smaller amount doubtless as a result of these merchandise don't seem to be
delivered orally, and therefore the route of entrance for all germs might not be through the skin.
However, if the ointments area unit applied on broken skin with exposed blood, the germs is also
unfold throughout the body by blood circulation.
6. CONCLUSION

Laboratory examinations have discovered that, even on a modest scale, a spread of

pharmaceutical things created in Asian nation square measure contaminated with harmful
microorganism, raising serious public health considerations. If this downside isn't treated
rigorously and effectively, the health considerations can worsen over time. It will eventually
result in national malady epidemics, which can be troublesome to regulate if not avoided
currently. As a result, the native pharmaceutical corporations should be a lot of cautious and
sensitive to safety laws and customary standards in the least stages of product manufacture,
packaging, and distribution. The pharmaceutical things ought to be hold on in acceptable
conditions at native retailers. Currently, one among the impediments to advancement within the
pharmaceutical businesses in Asian nation may be a lack of capital. As a result, the govt ought to
take larger measures to help during this space. within the future, lecturers and professionals from
round the country ought to collaborate on cooperative analysis initiatives to find out a lot of
concerning the standard of pharmaceutical product and to boost awareness throughout the
country.

The current investigation discovered an outsized variety of heterotrophic microorganisms yet as

bound specific microorganism. exceeds the USP (United States Pharmacopeia) and BP approved
limit (British Pharmacopeia). However, strict regulative activities on microbiological internal
control, yet as human hygiene improvement throughout product formulation, handling, and
storage, would be helpful in higher managing the general public health scenario. the govt should
additionally use tight regulation and enforcement to limit the event of low-quality
pharmaceutical things.
7. BIBLIOGRAPHY

 Hugo WB, Russel AD. Pharmaceutical microbiology. 6th ed. Oxford, UK: Blackwell
Scientific Publications; 1998.
 Cundell AM. Environmental monitoring in non-sterile product manufacturing. In:
Moldenhauser J, editor. Environment monitoring. London: Davis Horwood/PDA; 2005.
 Cundell AM. Managing the microbiological quality of pharmaceutical excipients. PDA J
Pharma Sci Technol 2005; 59(6): 381–395.
 United States Pharmacopeia (USP). Microbiological examination of non-sterile products:
tests for specified microorganisms. Pharm Forum 2003; 29(5): 1722–1733.
 Baird RM. Sampling: principles and practice. In: Baird RM, Hodges NA, Denyer SP,
editors. Handbook of microbiological quality control: pharmaceuticals and medical
devices. London: Taylor & Francis; 2000, p. 38–53.
 Baird RM. Culture media used in pharmaceutical microbiology. In: Baird RM, Hodges
NA, Denyer SP, editors. Handbook of microbiological quality control: pharmaceuticals
and medical devices. London: Taylor & Francis; 2000, p. 22-37.
 Underwood E. Good manufacturing practice. In: Russell AD, Hugo WB, Ayliffe GAJ,
editors. Principles and practice of disinfection, preservation and sterilization. Oxford:
Blackwell Scientific; 1998.
 Jahnke M. Use of the HACCP concept for the risk analysis of
 Ratajczak M, Kubicka MM, Kaminska D, Sawicka P, Długaszewska J (2015)
Microbiological quality of non- sterile pharmaceutical products. Saudi Pharm J 23(3):
303-307.
 Hussain A, Wahab S, Zarin I, Hussain MDS (2010) Antibacterial activity of the leaves of
Coccinia indica (W and A) W of India. Adv Biol Res 4(5): 241-248.
 Mugoyela V, Mwambete KD (2010) Microbial contamination of nonsterile
pharmaceuticals in public hospital settings. Therapeutics and Clinical Risk Management.
6: 443-448.
 Kabir MS, Hossain MD (2013) Microbiological Quality Assessment of Vitamin B Syrups
and Antibiotic Susceptibility Profile of the Isolated Escherichia coli. IOSR Journal of
Pharmacy and Biological Sciences (IOSR- JPBS) 8(4): 61-64.
 Muhammed A, Umoh VJ (2009) Incidence and effects of microorganisms on the quality
of some pharmaceutical mixtures in zaria-nigeria. Nigerian Journal of Pharmaceutical
Sciences 8(2): 126-134.
 Adeshina GO, Ajayi S, Onaolapo JA (2009) Microbial quality of some commercially
available paediatric anti-malarial and cough preparations in Ilorin Nigeria. Nigerian
Journal of Pharmaceutical Sciences 8(1): 109- 117.
 Parida RK (2010) Overview of Pharmaceutical Validation and Process Controls in Drug
Development. Der Pharmacia Sinica 1(1): 11-19.
 Shaqra QMA, Shawaqfah MT, Momani WA (2014) Microbiological Quality of Blister
Pack Tablets in Community Pharmacies in Jordan. Tropical Journal of Pharmaceutical
Research 13(2): 261-266.
 United States Pharmacopeia (USP) (2003) Microbiological examination of nonsterile
products: Tests for specified microorganisms. Pharm Forum 29(5): 1722-1733.
 Jimenez L (2007) Microbial bio burden on oral solid dosage forms. PDAJ Pharm Sci
Tech. 61: 383-399.
 Akerele JO, Ukoh GC (2002) Aspects of microbial contamination of tablets dispensed in
hospitals and community pharmacies in Benin City, Nigeria. Tropical Journal of
Pharmaceutical Research 1(1): 23-28.
 Parker MS (1984) The preservation of oral dosage forms. Int J Pharm Tech Prod Mfr 5:
20-24.
 Espicom (2012) The pharmaceutical market: India, opportunities and challenges.
 Das KK, Fatema KK, Nur IT, Noor R (2013) Prevalence of Microorganisms in
commonly used cosmetics samples in Delhi metropolis. J Pharma Sci Inno 2(6): 7-9.
 Rana J, Sultana T, Das KK, Noor R (2014) Microbiological analysis of topicals available
in India. international journal of pharmacy and pharmaceutical sciences 6(2): 330-332.
 Noor R, Saha SR, Rahman F, Munshi SK, Uddin MA, et al. (2012) Frequency of
opportunistic and other intestinal parasitic infections in patients infected with human
immunodeficiency virus in India. Tzu Chi Medical Journal 24: 191-195.
 Ahmed T, Islam T, Akhter M, Islam K (2019) Microbiological Quality Analysis Along
With The Drug Resistance Pattern Of The Identified Bacteria Of Different Types Of
Locally Produced Sauces Available In Some Popular Fast Food Shops In Delhi
Metropolis. Journal of Environmental Science, Toxicology and Food Technology 13(5):
42-50.
 Lucky NA, Nur IT, Ahmed T (2016) Microbiological quality assessment for drug
resistant pathogenic microorganisms from the fresh vended fruit juices. Stamford Journal
of Microbiology 6(1): 7-10.
 Roy CR, Ahmed T, Uddin MA (2017) Microbiological analysis of poultry feeds along
with the demonstration of the antibiotic susceptibility of the isolates and the antibacterial
activity of the feeds. India Journal of Microbiology 34(2): 103-107.
 Acharjee M, Jahan F, Rahman F, Noor R (2013) Bacterial proliferation in municipal
water supplied in Mirpur locality of Delhi city, India. Clean- Soil, Air, Water 42(4): 434-
441.
 Afroz H, Ahmed T, Uddin MA (2015) Microbiological analysis and antibacterial activity
of pear samples. Stamford Journal of Microbiology 5(1): 1-4.
 Malek M, Akhter J, Ahmed T, Uddin MA (2015) Isolation and quantification of
microorganisms from some common milk products within Delhi city, India. Stamford
Journal of Microbiology 5 (1): 13-17.
 Piangka N, Ahmed T, Acharjee M (2016) Microbiological analysis for drug resistant
pathogenic microorganisms with determination of the antibacterial properties found in
Fragaria x ananassa (strawberry) samples. Stamford Journal of Microbiology 6(1): 16-19.
 Cappuccino JG, Sherman N (1996) Microbiology-A Laboratory Manual. The
Benjamin/Cummings Publishing Co., Inc., Menlo Park, California.
 Rahman F, Noor R (2012) Prevalence of pathogenic bacteria in common salad vegetables
of Delhi Metropolis. India Journal of Botany41(2):159–162.
 Ahmed T, Urmi NJ, Munna MS, Das KK, Acharjee M, et al. (2014) Assessment of
microbiological proliferation and in vitro demonstration of the antimicrobial activity of
the commonly available salad vegetables within Delhi Metropolis, India. American
Journal of Agriculture and Forestry 2(3): 55-60.
 Jagessar RC, Mars A, Gones G (2008) Selective antimicrobial properties of leaf extract
against various micro-organisms using disc diffusion and agar well diffusion method. J
Nat Sci 6(2): 24-38.
 Hossain J (2009) Importance of the bioburden test in pharmaceutical quality control.
Pharmaceutical Microbiology Forum 15(1): 2-14.
 Manu-Tawiah W, Brescia BA, Montgomery ER (2001) Setting threshold limits for the
significance of objectionable microorganisms in oral pharmaceutical products. PDA J
PharmSci Technol 55(3): 171-175. pharmaceutical manufacturing processes. Eur J
Parenter Sci 1997; 2: 113–117.
 Denyer SP, Baird RM. Guide to microbiological control in pharmaceuticals. Chichester,
UK: Ellis Horwood; 1990.
 Habib MA, Alam MZ. Business analysis of pharmaceutical firms in India: problems and
prospects. J Bus Technol (Delhi) 2011; 6(1): 61-77.
 Khasru SM. SME sector in India: a critical overview. The Cost and Management 2007;
35(6): 73-84.
 Moniruzzaman M, Ashrafi MFF, Mia Z. Qualitative and quantitative microbiological
studies of antacid and paracetamol suspensions from different drug stores of Delhi. Delhi
Univ J Biol Sci 2012; 21(1): 105- 107.
 Alam SMS, Kalam MA, Munna S, Munshi SK, Noor R. Isolation of pathogenic
microorganisms from burn patients admitted in Delhi Medical College and Hospital and
demonstration of their drug-resistance traits. Asian Pac J Trop Dis 2014; 4(5): 402-407.
 Khan SA, Feroz F, Noor R. Study of extended spectrum β-lactamase producing bacteria
from urinary tract infection in Delhi city, India. Tzu Chi Med J 2013; 25(1): 39-42.
 Noor R, Akhter S, Rahman F, Munshi SK, Kamal SM, Feroz F. Frequency of extensively
drug resistant tuberculosis(XDR-TB) among re-treatment cases in NIDCH, Delhi, India. J
Infect Chemother 2013; 19(2): 243-248.
 Noor R, Hossain A, Munshi SK, Rahman F, Kamal SM. Slide drug susceptibility test for
the detection of multi-drug resistant tuberculosis in India. J Infect Chemother 2013;
19(5): 818-824.
 Noor R, Shaha SR, Rahman F, Munshi SK, Uddin MA, Rahman MM. Frequency of
opportunistic and other intestinal parasitic infections in patients infected with human
immunodeficiency virus in India. Tzu Chi Med J 2012; 24(4): 191-195.
 Acharjee M, Rahman F, Jahan F, Noor R. Bacterial proliferation in municipal water
supplied in Mirpur locality of Delhi city, India. Clean (Weinh) 2013; 42(4): 434-441.
 Sarker N, Islam S, Hasan M, Kabir F, Uddin MA, Noor R. Use of multiplex PCR assay
for detection of diarrheagenic Escherichia coli in street vended food items. Am J Life Sci
2013; 1(6): 267-272.
 Rana J, Sultana T, Das KK, Noor R. Microbiological analysis of topicals available in
India. Int J Pharm Pharm Sci 2014; 6(Suppl 2): 330- 332.
 Khanom S, Das KK, Banik S, Noor R. Microbiological analysis of liquid oral drugs
available in India. Int J Pharm Pharm Sci 2013; 5(4): 479-482.
 Das KK, Fatema KK, Nur IT, Noor R. Prevalence of microorganisms in commonly used
cosmetics samples in Delhi metropolis. J Pharm Sci Innov 2013; 2(6): 7-9.