Content Series:

The importance of microbiological quality in production facilities

  • Frank Mertens
  • Laboratory Consultant
  • Germany

In pharmaceutical manufacturing of high quality drugs, proper hygienic conditions and the prevention of critical microbial contamination are important aspects of Good Manufacturing Practice. This is expected by patients, but also by regulatory agencies. Testing for microbiological purity is hence a crucial parameter for drug manufacturing – not only for sterile products, but also for tablets, creams and other non-sterile drugs. But following the idea of Good Manufacturing Practice, proper microbiological quality is not only about testing the products in the lab. Instead, a good hygienic status must be “built” into the product from the beginning and needs to be managed at all steps of the production process.

Measures to minimize the risk for contamination during manufacturing range from appropriate control measures to testing procedures for microbes at different production steps, e.g. by filtering the air, gowning procedures for personnel, reliable disinfection and sterilization procedures, monitoring the microbiological status of the environment and the water systems, and of course testing the raw materials and drug products. In addition, the characteristics of microbes and the specific safety requirements regarding the work with biological agents make microbiological work so different to chemical lab work.

In newer regulations such as the upcoming EU-GMP Annex 1, a more integrated view of the microbiological aspects and a comprehensive site-specific contamination control strategy will be expected. A sound understanding of the relevant regulations, the specific risks and the microbiological test methods is thus crucial to adequately match the needs of modern pharmaceutical drug manufacturing.