Join your PDA Metro Chapter for an evening discussion on microbiological contamination prevention in the non-sterile manufacture of drugs and consumer products being paramount in a robust and reliable supply chain, and consumer safety environment.
During this discussion and presentation we will focus on what a microbiological risk assessment is, where to focus in the manufacturing facility and, share lessons learned from inadequate outcomes from assessments.
The primary areas of focus include:
- Equipment design
- Equipment preventative maintenance
- Cleaning of equipment
- Sanitization of equipment
- Water system design and microbiological controls
- Raw materials
As you know, Microbiology is a highly variable life-science. Relying solely on QC testing of materials and final products is not a leading indicator of contamination control, as sampling of these is minuscule compared to the overall size of the batch.
Placing emphasis on the above discussion points will drive assurance that each system is under control, by design, not by testing.
Furthermore, we are all consumers and patients, and nobody wants to use consumer products and/or drugs which are contaminated with potential pathogenic microorganisms, and no company who manufactures them wants to face recalls, and the damaging publicity associated with them.
Therefore, we as quality assurance/control microbiologists, have an obligation to ensure that the drugs and products our company manufactures are safe to use, and will remain stable during shelf-life, as our population of consumers/patients is vast, from infants, to children, adolescents to adults to elderly.
Please submit questions to our speaker at [email protected]
More information coming soon.