The Role of QC Documentation in GMP
Every step of API production must be documented to meet GMP and ICH guidelines. Proper QC records ensure traceability, reproducibility, and regulatory compliance.
Microchem’s Approach to Documentation
We prepare and maintain:
- Analytical test reports
- CoAs (Certificates of Analysis)
- Deviation and OOS reports
- Controlled batch records and logbooks
Aligned with Global Regulatory Expectations
Our documentation meets EU GMP, FDA, and WHO standards, ready for audits and submission.
Trust Microchem to manage your QC records with precision and compliance.