Quality Assurance
GMP Compliance
Our team can not only help you develop/implement an effective Quality Management System (QMS), but we can also take care of improving the current QMS to ensure compliance with NHP GMP requirements. Our services include:
- Drafting Standard Operating Procedures (SOPs) and revisions
- Preparation and review of Finished Product Specifications (FPS)
- GMP training programs
- Assisting with GMP audits.
- Mock GMP audits
- Preparing Quality Assurance Reports (QAR) for manufacturing, packaging, labeling and warehousing facilities.
- Reviewing/Drafting quality technical agreements
- Reviewing/drafting stability study protocols
