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Human civilization has come a long way when it comes to the studies & invention in the field of pharmacology & toxicology. People have swallowed elixers, inhaled vapors & applied ointment in the name of healing for millennia. From the pre-historic usage of naturally occurring alkaloids in plants to a blockbuster drug aspirin, the advent of novel medication drugs is a necessity for the continuous betterment of mankind. Hence, the existence of microbiology in pharmaceutical industry is indispensable.
Microbiology is the study of Microorganisms such as bacteria, fungi, mold, viruses & these are pertinent to the production of antibiotics, enzymes, vaccines & other pharmaceutical products. Generally, pharmaceutical microbiology provides knowledge and understanding with regards to the significance of the presence of bacteria, yeasts, moulds, viruses and toxins in pharmaceutical raw materials, intermediates, products and pharmaceutical production environments, as well as the microbiological control of pharmaceutical products, production environments and people.
The above-mentioned parameters are the basic platform for the various testing techniques that finally ensure the safety & efficacy of pharmaceutical products. Medicine is rigorously tested for safety & effectiveness before making it available to the consumer patients.
During recent years we have witnessed the rise in microbiologically related drug recall by pharma giants voluntarily or ordered by govt. institutions. A drug recall occurs when over the counter medicine is removed from the market is either found to be defective or potentially harmful. One of the factors apart from mis-labelling or poor packaging is the contamination of the drug during production or distribution. Compromise in product quality related to purity or unhygienic manufacturing practices lead to microbiological product recall to prevent harmful effects to the consumers or further deteriorate their health.
The code of federal regulations provides some guidance:
1.21 CFR 211.84(d)(6) “Each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use.”
2.21 CFR 211.113(a) “Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.”
3.21 CFR 211.165(b) “There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.”
Below is the list of few among many other objectionable microorganisms that have been cited in past recalls of the drug.
Quality Control microbiology is an essential function of the pharmaceutical industry. Drug manufacturers must thoroughly test materials, processes, equipment, techniques, environments and personnel in order to ensure their final products are consistent, safe, effective and predictable.
The guidelines to ensure quality, safety, sterility & accurate potency of the drug during its development cycle is followed through existing pharmacopeias.
A Pharmacopeia is an organization that develops and publishes standards for manufacturing prescription and over-the-counter medicines as well as other healthcare products.
This fundamental principle of pharmacopoeia compliance is an important consideration for the bio/pharmaceutical industry, including innovator, generic, virtual, and start-up companies who discover, develop, manufacture, and distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these products.
Three major pharmacopeias throughout the world include:
The United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP).
Each of these organizations has their own set of standards, however the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is working to facilitate international harmonization in the interpretation and application of technical guidelines and requirements for the pharmaceutical industry.
Various QC Microbiology techniques used in pharmaceutical industry are as follows;
1.Sterility testing by membrane filtration or by direct inoculation
2.Growth promotion test of microbiological media
3.Microbial Limit test
6.Preservative effectiveness test
7.Environmental monitoring of clean rooms
8.Bacterial Endotoxin testing.
Pharmaceutical microbiology is imperative part of laboratory routine that is not only important for compliance with the standards but also reduces the risk to consumer.
Note- ABDOS product offerings for the microbiology pharmaceutical industry are as follows;
1.Centrifuge & micro centrifuge tubes
2.Cryovial & freezing tubes
3.Screw cap vials
4.Liquid handling products like tips, pipettes, serological & Pasteur pipettes
6.Petri dishes, loops & spreaders
7.Beakers, measuring cylinders, bottles & carboys
9.Various routine laboratory instruments