GMP Regulatory Actions
The response to a regulatory audit with significant findings may overwhelm an already busy staff consumed with the day-to-day business of your Company. There is no shortage of microbiology-related regulatory findings as a search of the FDA actions will certainly demonstrate. Depending on the nature of your products and manufacturing processes these could well be some of the major issues cited. MicroGuard Consulting can serve as adjunct staff to assist your Company’s response to GMP Regulatory Actions, resolution of microbiological issues, execution of corrective actions, and evaluation of suitability of corrective actions. Examples of items we can help with include:
- Microbial control issues
- Recurrent microbial contamination issues
- Disinfecting practices and validation of disinfectants
- Failure to set appropriate environmental limits or product acceptance criteria
- Exceeding limits and insufficient CAPA follow up
- Product complaints or recalls due to microbial contamination
- Insufficient investigations or failure to assess root cause
- Microbiology Laboratory non-compliance issues
- Deviations from documented microbial control practices or microbial methods
- Faulty aseptic technique
- Other relevant microbiology issues
