MICROBIOLOGICAL STANDARDS

OF PHARMACEUTICAL AND
HERBAL PRODUCTS
GROUP 4 PCT325
191101064 Badru Anu Mariam
191101075 Animashaun Yetunde Islamiat
191101065 Adegbola Isaiah Oluwatomiwa
191101076 Olufolarin John Oluwatomi
191101066 Ohaka Ugochi Terwase
191101079 Akinde Oluwaseun Funsho
191101067 Igbokei Mary Awele
191101080 Ayanwusi Abiola Samuel
191101068 Folami Hafsat Seyifunmi
191101081 Olaleye Precious Oluwatimininu
191101069 Bisayo Damilola Akorede
191101082 Akingboye Maxwell Olaoluwa
191101070 Pemi Taiwo Adedamola
191101083 Adekomi Daniel Ayomiposi
191101071 Lawal Opeyemi Olayinka
191101085 Okonkwo Chidinmma Chelsea
191101072 Mukadam Jamaldeen Olanrewaju
191101086 Tewogbola Tolulope Michael
191101073 Igboanugo Munachim Irene
191101087 Uba Chigozie Daniel
191101074 Moneke Joyce Chiagoziem
191101077 Babalola Faidat Adepeju
OUTLINE

•Microbiological standardization
•Pharmaceutical products
•Regulatory overview
•Pharmacopoeia standards for pharmaceuticals
•Herbal products and their microbiological standards
WHY IS IT IMPORTANT TO STANDARDIZE
PHARMACEUTICAL AND HERBAL PRODUCT
• Safety: to prevent infection, as contaminated pharmaceuticals or herbal products can
introduce harmful microbes leading to infection especially in immunocompromised
individuals
• Quality control: To ensure that each batch of product meets the same microbial
standards, providing consistent therapeutic effects.
• Efficacy: microbes can degrade active ingredients or alter their concentrations,
impacting the product’s effectiveness
• Research and development: Understanding the microbial content helps in designing
better preservation methods and improving formulations
WHAT IS MICROBIOLOGICAL
STANDARDIZATION?
• Microbiological standardization refers to the establishment of acceptable limits
for microbial contamination and methods to ensure those limits are met in
pharmaceutical products and other products to be consumed as drug
 WHAT ARE PHARMACEUTICAL PRODUCTS
• Pharmaceutical products refer to substances and formulations used in prevention,
diagnosis, treatment or cure of diseases.
• In microbiological terms, Pharmaceutical products can be divided into two groups
based on their requirements for microbial contamination control: We have Sterile
and Non-sterile .
• Non-sterile drugs must satisfy the appropriate microbiological purity criteria which
are included in pharmacopoeia monographs (Pharmacopoeias are known useful
tools in the quality assessment, as they set out the microbiological specifications,
criteria, and the methods for microbial examination of non-sterile products).
• These pharmaceutical products include Antibiotics, antifungals, antivirals,
antiparasitic, Vaccines, Probiotics, Sterile Products.
Sterile pharmaceutical products are those that must be completely free from any
viable microorganisms. These products are typically used in situations where the
presence of microbes could cause significant harm or infection. Common examples
include: Injectable Medications e.g IM, IV, SC injections, Opthalmic Preparation e.g eye
drops, Inhalations.

Non-Sterile pharmaceutical products do not completely require sterility, but they must
meet certain microbiological standards to ensure safety and efficacy common
examples include: tablet drugs, oral formulations, syrup, suspensions etc
HERBAL PRODUCTS

Herbal medicinal products exclusively contain one or more herbal

substances or preparations as active ingredients.
Herbal preparartions include tinctures, extracts, essential oils, and juices.
Herbal substances are mainly dried plants, plant parts.
Herbal teas are aqueous preparation s made by decoction, infusion,or
marceration, of one or more herbal substances.
TYPES OF HERBAL SUBSTANCES AND
PREPARATIONS
• Standardized herbal substances/preparations: these are adjusted to contain
specific amounts of one or more active components known for their
therapeutic effects.
• Quantified herbal substances/preparation: These are adjusted to contain
specific amounts of active markers (compound responsible for herb’s
activity) which are controlled within a defined range.
• Other herbal substances/preparations: these are not adjusted to contain
specific amounts of constituents.
 REGULATORY OVERVIEW
• Regulatory agencies such as the FDA and EMA play a crucial role in setting and enforcing standards for
pharmaceutical quality control. They establish guidelines and regulations to ensure that pharmaceutical
and herbal products meet stringent quality, safety, and efficacy standards.
• Food and Drug Administration (FDA): The FDA, based in the United States, is one of the leading
regulatory agencies responsible for protecting public health by ensuring the safety, efficacy, and security
of drugs, biological products, and medical devices.
• European Medicines Agency (EMA): The EMA, headquartered in Amsterdam, is responsible for the
scientific evaluation, supervision, and safety monitoring of medicines in the European Union.
• World Health Organization (WHO): The WHO, a specialized agency of the United Nations, provides
global guidance and standards for public health, including pharmaceutical products.
OTHER ORGANIZATIONS

• Here are other organization that contribute to industry guidelines and

standards
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH): The ICH is a global organization that
brings together regulatory authorities and pharmaceutical industry
representatives to develop harmonized guidelines for pharmaceutical
development and registration.
Pharmaceutical Research and Manufacturers of America (PhRMA): PhRMA
is a trade association representing the pharmaceutical research and
biotechnology companies in the United States. It may contribute to industry
guidelines and standards.
PHARMACOPOEIAL STANDARDS FOR
PHARMACEUTICALS
United States Pharmacopeia (USP): The USP sets standards for the identity,
strength, quality, and purity of medicines, food ingredients, and dietary
supplements in the United States.
European Pharmacopoeia (Ph. Eur.): The Ph. Eur. provides standards for
pharmaceutical substances and dosage forms in Europe. It is used byEuropean
Union member states and other countries as a basis for quality control of
medicines.
British Pharmacopoeia (BP): The BP contains monographs and standards for
pharmaceutical substances and products used in the United Kingdom and
many other countries.
• Both non-sterile pharmaceutical products and herbal products can be classified under the same
unit for microbiological standardization, especially when assessing microbial contamination
using methods like direct plating and colony-forming unit (CFU) counts.

• By applying the same microbiological methods and interpreting the results against established
standards, the safety and quality of these products is ensured. This approach helps in identifying
potential contamination issues and implementing necessary quality control measures.

• Acceptance criteria for non-sterile pharmaceutical products based upon the total
aerobic microbial count (TAMC) and the total combined yeasts/moulds count (TYMC)

• Acceptance criteria are based on individual results or on the average of replicate counts
when replicate counts are performed (e.g. direct plating methods). When an acceptance
criterion for microbiological quality is prescribed it is interpreted as follows:
— 10^(1) CFU : maximum acceptable count = 20;
— 10^(2) CFU : maximum acceptable count = 200;
— 10^(3) CFU : maximum acceptable count = 2000;
Total Aerobic Microbial count (TAMC) Total Yeast and Mould Count (TYMC)
MICROBIOLOGICAL STANDARDS FOR HERBAL PRODUCTS

Recommended microbial limits for herbal drugs (values in CFU/g)

• a United States Pharmacopoeia: The first value represents dried or powdered botanicals
and botanicals to be treated with boiling water before use; The second value represents
tinctures, powdered botanicals extracts, fluid extracts and nutritional supplements with
botanicals; The third value represents infusions/decoctions.
• b
European Pharmacopoeia: Herbal medicinal products consisting solely of one or more
herbal drugs (whole, reduced or powdered): the first value represents herbal medicinal
products to which boiling water is added before use; The second value represents herbal
medicinal products to which boiling water is not added before use.
• c WHO: The first value represents contamination of "crude" plant material intended for
further processing; The second value represents for plant materials that have been
pretreated (e.g. with boiling water as used for herbal teas and infusions) or that are used
as topical dosage forms; The third value represents For other plant materials for internal
use:
• d
Brazilian Pharmacopoeia: The first value represents herbal drugs to which boiling water
is added before use; The second value represents herbal drugs to which the extractive
process made in cold temperature; The third value represents final products for oral use. *
Limits are not specified.
OUR FOCUS IS THE MICROBIAL ASPECT OF QUALITY
• According to a research titled ‘Evaluation of Pharmaceutical and
Microbial Qualities of Some Herbal Medicinal Products in South Western
Nigeria’ the results showed the reasons why it is important to ensure
microbiological standardization
“The microbial load of the products varied considerably. Ten (47.6%) of the
samples were contaminated by E. coli, seven (33%) were contaminated by
Salmonella, fifteen (71.4%) were contaminated by Staphylococcus aureus and
twelve (57.1%) were contaminated by fungi’
CONCLUSION

• In conclusion, microbiological standardization is crucial for ensuring the quality,

safety, and efficacy of pharmaceutical and herbal products. By adhering to
regulatory standards, implementing robust quality control measures, and
following industry guidelines, manufacturers can safeguard product integrity
and protect public health. Continued advancements in microbiological testing
methods and practices will further enhance product quality and safety in the
pharmaceutical industry.
REFERENCES

• Tropical Journal of Pharmaceutical Research Vol. 6 (1) 2007: pp. 661-67

• https://www.ema.europa.eu/en/microbiological-aspects-herbal-medicinal-products-traditi
onal-herbal-medicinal-products-scientific-guideline
• https://www.legislation.gov.au/F2018L01685/latest/text
• Freitas Araujo MG de and Maria T (2012) Microbial Quality of Medicinal Plant Materials. Latest
Research into Quality Control. InTech. Available at: http://dx.doi.org/10.5772/51072.

• Farmacopéia Brasileira. 1988 4. ed. São Paulo: Atheneu, Parte 1. pV.5.1.6.-1- V.5.1.7.-6
• The United States Pharmacopeia. 2005 28 ed. Rockville: United States Pharmacopeial Convention 2013
• European Pharmacopoeia. 2007 Microbiological quality of pharmaceutical preparations. Chapter 5.1.4, 6.
ed. Strasbourg: EDQM. 4451