GMP Requirements in Pharmaceuticals

Good Manufacturing Practice (GMP) is a regulatory framework ensuring that pharmaceutical products are consistently produced and controlled according to quality standards, minimizing risks to patients.

1. Quality Management System (QMS)

• Implement a robust QMS covering SOPs, documentation, audits, change control, CAPA.

• Quality assurance and quality control roles must be clearly defined.

2. Personnel & Training

• Adequate number of qualified staff.

• Initial and ongoing GMP training.

• Health, hygiene, and clothing requirements to prevent contamination.

3. Premises & Equipment

• Facilities must be clean, hygienic, well-maintained, and designed to prevent cross-contamination.

• Equipment must be qualified, calibrated, and maintained.

4. Documentation & Record Keeping

• Follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available).

• Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) must be complete and accurate.

5. Materials Management

• Use only approved suppliers.

• Proper sampling, testing, and approval of raw materials.

• Control over storage and distribution.

6. Production Controls

• Follow validated manufacturing processes.

• In-process controls to ensure quality at every stage.

• Prevent mix-ups and cross-contamination.

7. Quality Control (QC) Laboratory

• Testing of raw materials, intermediates, and finished products.

• Use validated analytical methods (e.g., HPLC, GC).

• Maintain proper sample retention.

8. Validation & Qualification

• Process validation, cleaning validation, method validation.

• Equipment qualification (IQ, OQ, PQ).

9. Handling Deviations, OOS & Complaints

• Investigate all deviations, OOS/OOT results, and customer complaints.

• Implement effective CAPA.

10. Self-Inspection & Audits

• Regular internal audits to identify and correct compliance gaps.

• Be audit-ready for regulatory inspections (FDA, EMA, WHO, CDSCO, etc.).

Regulatory References

• WHO GMP guidelines.

• USFDA 21 CFR Part 210 & 211.

• EU GMP EudraLex Volume 4.

• ICH Q7–Q10.