Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist

API manufacturing inspections verify compliance with ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients and regulatory requirements from FDA, EMA, MHRA, and other health authorities. This inspection covers all critical GMP elements specific to API manufacturing.

  • Industry: Pharmaceutical & Life Sciences
  • Frequency: Annual / Pre-Regulatory Inspection
  • Estimated Time: 60-90 minutes
  • Role: QA Manager / Regulatory Affairs Specialist
  • Total Items: 31
  • Compliance: ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, FDA 21 CFR Part 211 cGMP for Finished Pharmaceuticals, EU GMP Part II Basic Requirements for Active Substances, PIC/S Guidance on GMP for API PE 009-15 Part II, WHO GMP Guidance for Active Pharmaceutical Ingredients

Quality Management System

Review API quality management system elements.

  • Quality management system established per ICH Q7 Section 2?
  • Quality unit independent from production with authority to approve/reject batches?
  • Annual Product Quality Review (APQR) completed for previous year?
  • Change control system established and functioning?
  • CAPA system in place with effective root cause analysis?

Production Controls

Review API production control measures.

  • GMP starting point defined and GMP applied from defined point onward?
  • Batch production records complete per ICH Q7 Section 6.5?
  • Yield calculation and reconciliation performed for each batch?
  • Critical process steps have in-process controls and verification?
  • Any reprocessing or reworking documented and quality-approved?

Laboratory Testing

Review API QC laboratory compliance.

  • API specifications approved and based on regulatory requirements?
  • Analytical methods validated per ICH Q2(R1)?
  • Reference standards qualified and stored appropriately?
  • OOS investigation procedure in place and functioning?
  • Certificates of Analysis accurately reflect test results?

Impurity Controls

Verify API impurity control program.

  • API impurity profile established and controlled per ICH Q3A/Q3B?
  • Genotoxic impurity controls in place per ICH M7?
  • Residual solvent testing performed per ICH Q3C?
  • Elemental impurity risk assessment and controls per ICH Q3D?
  • Impurity results trended to detect process changes?

Materials and Supply Chain

Review raw material and supplier controls.

  • All raw material suppliers qualified and audited?
  • Identity testing performed on all incoming API starting materials?
  • CoA verification against internal testing performed?
  • Supply chain changes going through change control?
  • API storage and distribution compliant with GDP requirements?

Regulatory Readiness

Assess readiness for regulatory authority inspection.

  • Site Master File (SMF) or Drug Master File (DMF) current?
  • Manufacturing process consistent with approved dossier/DMF?
  • All previous regulatory inspection findings closed?
  • Qualified Person (EU) or responsible persons designated and qualified?
  • GMP certificate current (EU GMP certificate or equivalent)?
  • Self-inspection program in place with recent internal audit?

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Why Use This Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist?

This active pharmaceutical ingredient (api) manufacturing inspection checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / regulatory affairs specialist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: annual / pre-regulatory inspection.

Ensures compliance with ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, FDA 21 CFR Part 211 cGMP for Finished Pharmaceuticals, EU GMP Part II Basic Requirements for Active Substances, PIC/S Guidance on GMP for API PE 009-15 Part II, WHO GMP Guidance for Active Pharmaceutical Ingredients. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist cover?

This checklist covers 31 inspection items across 6 sections: Quality Management System, Production Controls, Laboratory Testing, Impurity Controls, Materials and Supply Chain, Regulatory Readiness. It is designed for pharmaceutical & life sciences operations and compliance.

How often should this checklist be completed?

This checklist should be completed annual / pre-regulatory inspection. Each completion takes approximately 60-90 minutes.

Who should use this Active Pharmaceutical Ingredient (API) Manufacturing Inspection Checklist?

This checklist is designed for QA Manager / Regulatory Affairs Specialist professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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