Pharmig is proud to have launched (at its 31st Annual November Conference) the 2nd edition of its 'Guide to Microbiological Control for Non-Sterile Pharmaceuticals'
The Guide is relevant to non-sterile pharmaceutical, cosmetic and toiletry manufacturing industries as there have been significant changes in the microbiological regulations, controls, and testing of non- sterile products. Much of the changes have been prompted by the many recalls of non-sterile products worldwide.
As many of you know for the microbiologist, non-sterile manufacturing offers a true test of their skills, experience and agility of thought. By their definition, non-sterile products are ‘allowed’ to have microorganisms in them. It is often down to the microbiologist to assess which ones are OK and which ones pose a risk. A risk that is twofold, either to the patient using the product, or to the stability of the product itself. Unlike sterile manufacturing, where the answer to microbial contamination in a product is black and white, non-sterile microbiology requires a true appreciation of risk-based decision making. A delicate balancing act needs to be maintained between an overly pragmatic approach to the recovery of the wrong type, or numerically significant microbes and the destruction of perfectly good product. I would encourage – as indeed this guidance does – microbiologists to leave the safe, enclosed confines of the laboratory and get into the manufacturing plant. Understand your process risks and controls, the interaction of your people, and the risks from water systems. This is a publication on non-sterile microbiology written by microbiologists with expertise and experience in the industry. This guide should be a very useful addition to the microbiologist’s armoury, containing advice, help and guidance and covers.
- Microbiological testing and data handling
- Facility and equipment design
- Objectionable microorganisms
- Cleaning & disinfection
- Risk assessment & data management
- Environmental monitoring
- Regulatory expectations for non-sterile manufacture
A practical guide for experienced and non-experienced Microbiologists, Quality Assurance Personnel and Qualified Persons.