What is GMP – Good Manufacturing Practice?
Quality system that ensures products are: ✔️ Safe
✔️ Effective
✔️ Consistently high-quality
It governs every step of the manufacturing process — from raw materials to packaging.
📌 Here’s a quick overview of the 10 core components of GMP:
1️⃣ Facilities – Clean, organized, and contamination-proof.
2️⃣ Raw Materials – Approved sources, fully tested.
3️⃣ Personnel – Trained, hygienic, and healthy.
4️⃣ Equipment – Clean, calibrated, and well-maintained.
5️⃣ SOPs – Every process follows written procedures.
6️⃣ Documentation – Real-time records of every action.
7️⃣ Quality Control – Physical, chemical, and microbiological testing.
8️⃣ Sanitation & Hygiene – Scheduled cleaning and monitoring.
9️⃣ Complaints & Recalls – Quick investigation and action.
🔟 Internal Audits – Regular self-inspection and corrective action.
🛡️ Why is GMP crucial?
Because even a small mistake can lead to:
Infections
Poisoning
Ineffective products
Loss of public trust
That's why regulatory authorities like FDA and EMA will not approve any product that doesn’t comply with GMP.
No comments:
Post a Comment