Free GMP Internal Audit Checklist For Manufacturing | PDF

GMP internal audit checklist template

The GMP internal audit checklist is designed specifically for quality managers and compliance teams in regulated manufacturing environments. It helps you ensure adherence to Good Manufacturing Practice standards across your facilities. This template guides you through critical checkpoints such as documentation, hygiene, equipment validation, and process controls, so you can confidently address regulatory requirements and minimize the risk of compliance gaps.

In a survey by The FDA Group, 9 out of 10 life science quality leaders listed maintaining compliance as one of their top three challenges, underscoring the ongoing need for effective GMP audit tools. For broader needs, you can also explore our ISO 9001 or internal quality audit checklists, but this GMP-specific template delivers focused, actionable support for your manufacturing operations.

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Preview of the template

Facility and Equipment

Are the facility and equipment properly designed, constructed, and maintained?

Are the facility and equipment clean, sanitized, and in good repair?

Are the facility and equipment calibrated and validated as appropriate?

Materials

Are materials properly received, tested, and stored?

Are materials used within their expiry or retest dates?

Are materials handled and labeled properly?

Production

Are manufacturing processes validated and controlled?

Are in-process controls and tests conducted as per specifications?

Are deviations and investigations documented and addressed?

Quality Control

Are quality control procedures in place and followed?

Are samples collected, tested, and approved before release?

Are quality control records maintained and reviewed?

Documentation

Are all SOPs, policies, and records complete and up-to-date?

Are changes to documents reviewed and approved?

Are complaints, recalls, and investigations documented?

Personnel

Are personnel trained and qualified for their roles?

Do personnel follow GMPs and adhere to hygiene requirements?

Are responsibilities and reporting lines clearly defined?

Frequently asked questions

What are the most common issues found during gmp internal audits?

Common issues include incomplete documentation, inadequate employee training, poor hygiene practices, and failure to properly calibrate equipment. Addressing these findings quickly is key to maintaining compliance and avoiding regulatory actions or production downtime.

What steps should you take after identifying non-conformities in a GMP audit?

After finding non-conformities, document each issue, analyze the root cause, and assign corrective actions with clear deadlines. Follow up to ensure actions are completed and verify that changes have effectively resolved the compliance gaps.

How can you ensure that GMP internal audits are effective and unbiased?

Train auditors on current regulations, and rotate audit teams to avoid conflicts of interest. You can also use standardized checklists like the one above. Independent reviews and clear documentation help maintain objectivity and credibility in audit results.

What documentation should you maintain after completing a gmp internal audit?

After a GMP internal audit, companies should retain completed checklists, detailed findings, corrective action plans, and evidence of issue resolution. Proper documentation supports regulatory compliance and provides a reference for future audits or inspections.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.