Microbiology is the study of microorganisms such as bacteria, fungi, mold, and viruses, which are important in the manufacture of antibiotics, enzymes, vaccines, and other pharmaceutical products. Pharmaceutical microbiology, in general, provides knowledge and understanding of the significance of the presence of bacteria, yeasts, molds, viruses, and toxins in pharmaceutical raw materials, intermediates, products, and pharmaceutical production environments, as well as microbiological control of pharmaceutical products, production environments, and people.
During recent years we have witnessed the rise in microbiologically related drug recalls by pharma giants voluntarily or ordered by govt. institutions. A drug recall occurs when over-the-counter medicine is removed from the market and is either found to be defective or potentially harmful. One of the factors apart from mislabeling or poor packaging is the contamination of the drug during production or distribution. Compromise in product quality related to purity or unhygienic manufacturing practices leads to microbiological product recalls to prevent harmful effects to the consumers or further deteriorate their health.
All articles Below are related to Microbiology in Pharmaceuticals and will be updated whenever new updates are available:
- Microbiology Incubator: Principle, Working, Types, Parts, Use, Precautions and Limitations
- Depyrogenation vs. Sterilization; Understanding the Differences and Methods with Example
- Difference Between Positive and Negative Control
- Gowning Procedure in CleanRoom Area
- Sterilization, Method of sterilization, and Objective in Labs
- Procedure for Destruction Microbial waste by Autoclaving
- SOP on Cleaning Procedure for Sterility Failure investigation
- Aseptic and Sterile in Pharmaceutical
- Understanding Sterility Assurance Level (SAL) vs. Log Reduction in Pharmaceuticals
Some useful Guidelines for the Microbiology Section:
The code of federal regulations provides some guidance:
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.
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.
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.