RAW

MATERIALS
Contents..
 WHAT ARE RAW
 MATERIALS
All materials that? used into the manufacturing
of a finished bulk (even though it may not be
present in final product e.g. Certain solvents
etc.) and which are consumed by person using it
are called as raw materials.
 Raw materials can be either active drug or
inactive substances.
 eg. Hard gelatin capsules: even though it is
used to fill the blend of medicine, it is not
considered as package materials because it is
consumed by person using medicines.
 PURCHASE
SPECIFICATION
 Definition :
 Written guidelines that precisely define the
operational, physical, and/or chemical
characteristics, as well as the quality and quantity
of a particular item to be acquired.
 rawmaterial.do
 c Mode of purchasing :
 By inspection
 By sample
 By
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description of brand
  Steps involved in purchase procedure:
1. Purchase requisition
2. Selection of supplies
3. Inviting Quotation
4. Placing the order
5. Receiving the material
6. Checking of invoice or bill
7. Recording of bills in books
8. Releasing the payment to the
5 supplier
 Staff involved in purchasing have a particular and
thorough knowledge of products and suppliers.
 Raw material can be purchased from supplier named
in relevant specification or directly from producer.
 Specification established by manufacturer for the
starting materials be discussed with suppliers.
 Pharmacist or chemist, who is familiar with quality
requirement of various material purchase department
can be head of purchase department.
  Maintenance of stores
 Storage Area Specifications :-
- Sufficient Capacity
- Clean, Dry and Maintained within acceptable temp.
limit
- Designed and equipped reception area
- Ensuring of quarantine status
- Separate sampling area
- Segregation for storage of rejected, recalled or
returned material
- Safe and secure area for narcotics and highly
active, dangerous and risky material
- First in First out rule (FIFO)
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- First expiring First Out (FEFO)
  Storage conditions :-
- Room temp. Should be 30° C and R.
- 60%
H. A.C storage (25± 2 ° C & R.H. 45 – 55%)
- Low temp. storage 2 – 8 ° C
- Separate area for Sterile product storage in A.C
- Light sensitive material in amber color container
- Hermitically sealed container
 Labeling of material in storage area
- Designated name of product and internal code
reference
- Batch no. given by supplier
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- Status of Content
-
  During fully computerized system used, labeling
above
with information
all need not be necessary
 Check list before storage
- Integrity of package and seal
- Correspondence note for the order, delivery and
suppliers labels
 Check list during storage
-separation of rejected, recalled, quarantine, on
test, packaging materials.
-quality of materials
 Released by q.c. dept. only
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  Selection of Vendors
 Purpose :-
It is designed to evaluate suppliers
and manufacturers with an implementation scheme to
assure regulatory compliance.
 A system which assures that a supplier’s product is
produced under controlled conditions, resulting in
consistent quality conformance.
 Require fully involvement and agreement of both
partners.
 Vendor is classified by the finished dosage form
manufacturer relative to its credibility .
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  Determine the selling price of the API from the
i.e. the cost to the finished dosage form manufacturer.
vendor,
This information is needed for a profitability
evaluation of the finished pharmaceutical product
 Begin the actual process of vendor qualification–
evaluation of sample of API .
 The finished dosage form manufacturer should
conduct a vendor audit.
 Followings are too considered…
 Response to the quotations invited.
 The price is lowest or reasonableas compared
to the competitors.
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 His general behavior and attitude
when the raw materials are returned by the
purchaser and his reputation in the market.

SOP and Record of Vendor

Certification
- Selectionof Materialbased on ABC
analysis
- Selection of Vendor for above selected
material
1. Past history of supplies made by him
2. Trend of quality of material
12 3. Commitment to quality and delivery dates
 - Following process components should be studied with
supplier or manufactures
1. Study of suppliers mfg. process
2. Product specification and evaluation
3. Process evaluation
4.Process and specification changes & change control
system compliance
- Carried out and represent Formal technical
audit report of vendor.
- Based on audit finding vendor can be certified or
decertified.

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 Steps involved in vendor certification process
 Selection of customer team : to define the
objectives & the potential benefits.
 Supplier selection .
 Initial supplier
 Process
contacts. 1. supplier process.
elements: 2. specification
3. process
 Process and specification
evaluation
 changes. Customer
 Supplier
specification. 1. certificate of compliance
reporting : from supplier
2. feedback form to supplier.
Decertification : lesser status of “ approved” or “
 preferred” Adv. of certification process: - the tighter
specification range.
- reducing testing by
customer .
 SOP on receipt , storage ,sampling of
A. Receipt of materials:
materials.
i. Visual examination for all incoming materials
 Intact container, lid, seals
 Evidence of any physical damage to the containers
 Evidence of rodent or insect specification.
 Proper labeling in specified manner
ii. Points to be checked & recorded
 Date of receipt
 Name of product, batch no., control no.
assigned by manufacturer.
 Quantity received against
 document Name of supplier
 Purchase order no.
 Excise gate pass etc.
B. Storage of
materials
i. External: cleaning of after receiving
container storage &before
ii. Quantity verification
iii. Storage in specified area as per condition
 R.T./ A.C./ Cool /cold/ low humidity area.
iv. Storage as per quarantine status of the material
 received, sampled, approved, rejected .
C. Sampling of materials:
i. Sampling responsibility
ii. Sampling formula used
iii. Method of samplinge.g. top, middle, bottom
sample is required
i. Material wise quantity to be sampled as per
requirement of analysis.
ii. Sampling room specification:
 Temp.
 Relative humidity
 Air pressure
iii. Specific requirement for specialized product:
 Sterile products
 Poisons or potent drugs
 Beta lactum products
 Sex hormones
 Steroids
iv. Opening and closing of containers before&
after sampling.
v. dress code of people doing sampling
vi. Cleaning, drying, sanitization of utensils
used for sampling.
vii. Identification of sampled containers
viii. Sampled containers and sample collection
containers should have following details :
 Name of materials &
 manufacturer Batch no. for
 manufacturer
 Date of sampling
 CONTROL ON RAW
MATERIALS:
 Quality assurance should make periodic sanitation and
follow up to assure that deficiencies are corrected.
 Raw materials with abnormally high microbial
contamination may have to be subjected to a
sterilization procedure like heat treatment, radiation
or crystallization from a bactericidal solvent like
alcohol.
 Warehouses are the first operational area observed by
 the Following
auditor to check operational compliance with cGMP
elements need to be considered
& FDA regulation.
establishing
when warehouses operation:
cleanliness , floors , lighting &
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SOPs .
 Finished Products
 A product in the marketable pack
 Practically a transportable pack
 E.g. shipper containing salable
 material
SOP forcontrolling (transfer, storage) of finished
products.
 Transferring of finished packs from transportable
packs to finished goods warehouse with
finished goods transfer note giving batch no., quantity,

date,Collect
time, and
etc. analyze the samples against
specification validated test methods. using
 part of sample kept as retained material
for it SOP.

 Indian Pharmaceuticals Limited
Full scale calibration of weighing balance.
Balance code:--------- ref SOP no: ------------
Weighing m/c no: ------- Capacity Min: ---------
Location no : --------- Capacity Max : -------
Calibration no : Month : -----------
------ Valid up to : Frequency : ---------
---------- Next calibration due
Usage capacity : on : --------
Min. ------
Sr no Calibration MCalibrated Observed deviation Calibrated Checked
date axfor wt for wt. by by
.
---
---
--
 Indian Pharmaceuticals Limited
List of standard weights
Sr no. weights Date of Validity of Remarks
calibration in any
collection
1 1.0 kg.
2 0.2 kg.
3 0.5 kg.
4 2.0 kg.
5 5.0 kg.
6 Etc.
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 Indian pharmaceutical limited
Balance cleaning record.
Date Type of Code Time of Cleaned Checked
no. of cleaning by by
balance balance
From To
 Indian pharmaceutical limited
Daily gross check of balance

Location : Ref . SOP no:

Type of Model no:
balance : Code Capacity: min :---- max: ----
No. :
Month
Date :
Zero remark sign date Zero remark
checked checked sign s
by by
 Raw material receiving observation
sheet

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Raw material sampling observation
sheet
Sr Batch Quantity M Exp. No of packs Sample Container
no No f sampled qty. No.
d Sampled
.

Qty. Per No. Total

Pack of Qty.
pack

Sr. No. Batch no. No. Pack Damaged Type of Remark

Damaged s

Observation during Sampling :

Form: Color:
Odor: Foreign matter:
Spillage if any:
Sampled by: Name: Date:
Sample Handed: A Ref No.
Over to:
 Daily stores Inward Reports of R.M
Date:
Sr. No. Name of Items Quantity on Challan Name of Party

Temperature and Relative Humidity Record

Department Month
Are Prescribed
a Range (a)For
Temp °C
(b)For % RH
Room Ref. SOP.
No. No.
Date Time Dry Wet bulb % RH Initials of Remarks
bulb temp °C Officers
temp °C
 References

 CGMP for Pharmaceuticals by Manohar A. Potdar

 GMP for Pharmaceuticals , Fifth edition , by Sidney H.
Willing.
 Pharmaceutical Industrial Management by G.Vidyasagar.
 gmp-quality.com