Good Manufacturing Practices (GMP) for APIs are essential to ensure that the Active Pharmaceutical Ingredients produced are of consistent quality and meet their intended use requirements. These guidelines are mainly described in ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

Key Points:

1. Scope:
   Applies to the manufacture of APIs for both human and veterinary use, covering all manufacturing stages — from raw materials to the final API.

2. Quality Management System (QMS):

   • Ensures a robust system for maintaining product quality.

   • Includes documentation, deviation management, change control, CAPA, and internal audits.

3. Personnel and Training:

   • Qualified and trained personnel must perform production and quality control activities.

   • Responsibilities and organizational structures should be clearly defined.

4. Buildings and Facilities:

   • Designed to minimize contamination and mix-ups.

   • Proper environmental controls and cleaning procedures must be established.

5. Equipment:

   • Equipment should be designed, qualified, cleaned, and maintained properly.

   • Preventive maintenance schedules and calibration records are required.

6. Documentation:

   • Batch records, SOPs, specifications, and logbooks should be maintained and controlled.

   • Data integrity principles must be followed (ALCOA+).

7. Production Controls:

   • Includes process validation, in-process controls, and monitoring of critical process parameters.

   • Raw material quality and supplier qualification are key elements.

8. Quality Control:

   • Analytical testing ensures the API meets specifications.

   • Stability studies must demonstrate the product’s shelf life.

9. Change Control and Deviation Handling:

   • Any change to equipment, process, or material must be documented and assessed for impact.

   • Deviations must be investigated, and CAPAs implemented.

10. Audits and Self-Inspection:

    • Regular internal and supplier audits to ensure ongoing compliance.

References:

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

• WHO TRS 986, Annex 2: GMP for APIs

• US FDA 21 CFR Part 210 & 211