GMP Documentation
Our industry is driven by GMP Documentation that is governed by regulations. Various documents prepared by your company translate these regulations into meaningful policies, practices and procedures that are designed to ensure that the regulations are met and products are produced and tested according to design and requirements.
MicroGuard Consulting will review/revise/or prepare relevant microbiology policies and procedures to meet these regulatory requirements including:
- Microbiology test method validation and testing
- Microbiology media preparation and quality control
- Microbiology laboratory practices
- Media fill (process validation)
- Environmental monitoring
- Aseptic techniques
- Out-of-specification/Investigation
- Corrective and preventative actions
- Cleaning and disinfecting
- Microbial release and stability specifications
- Gowning
- Sterilization validation and sterilization
- Microbial identification
- Microbial cell storage and culture collection
- Training
