Sterility Testing: Regulatory Compliance
Microchem’s sterility assurance offering is fully GMP compliant for drugs, biologics, and devices.
Critical GMP compliance elements of our Sterility Assurance offering include:
- ISO 17025 backbone
- Robust, detailed procedures in the form of SOPs with proper review, control, and authorization
- Robust training program with proficiency demonstration
- Out-of-specification result procedures with Sponsor notification
- Quarantine of media and reagents until authorized for use
- Method and equipment validations
- QC review of data and reports and oversight by Quality department
- Secure storage of test-related documentation
Microchem is eager to earn the trust and business of the companies that manufacture sterile medical products. If your company is interested in moving to a better, more responsive lab, email [email protected] or call 512-310-8378 to get the conversation started.
