When sourcing Active Pharmaceutical Ingredients (APIs), it’s not just about cost or availability—quality and compliance are critical. A single weak link in the supply chain can compromise patient safety and regulatory approval.
At Ramoliya Pharmaceuticals, we follow a strict API GMP checklist to ensure our 250+ APIs meet the highest global standards. Here’s a practical guide for procurement, QA, and regulatory teams.
What Is GMP in APIs?
Good Manufacturing Practice (GMP) ensures that APIs are consistently produced and controlled according to quality standards.
For APIs, this covers:
- Manufacturing processes
- Facility & equipment hygiene
- Documentation practices
- Testing & release
API Quality Checklist for Buyers
When auditing a supplier or reviewing documents, here’s what you must check:
- Certificate of Analysis (CoA)
- Confirms batch quality (assay, purity, impurities, microbial limits).
- Must be signed by the QA head of the manufacturing facility.
- Material Safety Data Sheet (MSDS)
- Contains safety info on handling, storage, and transportation.
- Crucial for regulatory submissions and shipping.
- Stability Studies
- Accelerated (40°C / 75% RH) → Predicts shelf life.
- Long-term (25°C / 60% RH or 30°C / 65% RH) → Ensures stability in real conditions.
- Essential for APIs shipped to Zone IV/IVb (hot & humid regions).
- GMP Certificate
- Should be issued by a recognized regulatory body.
- Confirms the facility follows WHO GMP / US FDA / EU GMP guidelines.
- Impurity Profile
- Lists related substances and residual solvents.
- Must comply with ICH Q3A/Q3C limits.
- Vendor Qualification & Audit Reports
- Check whether the manufacturer has passed buyer audits.
- Review SOPs, batch records, and QA practices.
Why This Checklist Matters
- Ensures regulatory compliance in export markets
- Protects against supply chain risks
- Builds trust with healthcare providers and partners
Ramoliya’s Assurance
At Ramoliya, our APIs come with:
- Complete CoA, MSDS, stability data
- GMP-certified facilities
- Strong QA/QC teams that verify every batch before shipment
Explore our API portfolio (250+) for globally trusted pharmaceutical ingredients.
FAQs
Q1: Who issues the CoA for APIs?
The manufacturer’s Quality Assurance department issues it for each batch.
Q2: Are stability studies mandatory for all APIs?
Yes, especially for export to hot/humid climates and regulatory approval.
Q3: Can buyers audit API manufacturers?
Yes—serious buyers should conduct audits or request audit reports.
Conclusion
A robust GMP checklist is the backbone of API sourcing. With Ramoliya’s end-to-end quality framework, buyers can be confident about safety, compliance, and reliability.