GMP Audit Checklists

Measure operations compliance with manufacturing standards with a mobile app

Published November 19th, 2020

What is a GMP Audit Checklist?

A Good Manufacturing Practices (GMP) audit checklist is a tool used by manufacturers to ensure that food, pharmaceutical, medical, and cosmetic products are of consistent quality and in compliance with manufacturing standards. Performing regular GMP audits protects a business from product safety issues, product recalls, and legal and regulatory problems.

How to Prepare for a GMP Audit

Review the scope of the GMP audit 

Review in advance the coverage of the audit, such as the locations and processes to be audited, as well as the timeframe needed by the auditors.

Communicate the audit plan to your team

Make sure that the plan is communicated to all site personnel, especially those whose areas will be audited. Clearly list the areas / systems / products to be audited and list
specific dates for each of the audits. 

Know  which standards are covered

Identify which standards will be covered in the GMP audit.  Audit standards may include:

  • Applicable policies
  • Laws and regulations
  • Procedures
  • Management system requirement; or
  • Contractual agreement with suppliers

Be sure that you are precisely familiar with the standards and any policies regarding their explanation and application.

Know your documents and prepare them ahead of time

Prior to the audit, ensure that your team has reviewed any documentation that an auditor is likely to request. Make sure that all documentation is accessible and that all circulated documents are ‘controlled copies’ and up-to-date.

The documentation may include:

  • Relevant management system documents and records
  • Applicable standards
  • Site master file
  • Training records
  • SOP’s
  • Previous audit reports

Typically, the auditor will review the following documents before arriving on your site:  Site Master File (if the auditor is new to your site)  Validation Master Plan previous audit findings and your responses complaints and adverse events. 

Define tour routes

 It will be helpful to establish routes through the facility to have an efficient GMP audit. Ensure that your auditees are assigned in areas and are capable of answering auditors’ questions. 

Auditing Tool for GMP Compliance

Conduct a thorough and systematic GMP audit using a digital checklist. Use iAuditor, the world’s #1 inspection app, to replace existing workflows involving paper forms, spreadsheets, scanning and faxing, and perform audits on your mobile phone or tablet. With iAuditor you can:

  • Create mobile-ready GMP audit checklists
  • Empower teams to complete GMP audits using a smartphone or tablet
  • Attach photos and make annotations within the app
  • Save all reports online. Preview a sample report here.
  • Use for free with small teams. Unlimited reports and storage for premium accounts Compare pricing plans.

Published November 19th, 2020

What is a GMP Audit Checklist?

A Good Manufacturing Practices (GMP) audit checklist is a tool used by manufacturers to ensure that food, pharmaceutical, medical, and cosmetic products are of consistent quality and in compliance with manufacturing standards. Performing regular GMP audits protects a business from product safety issues, product recalls, and legal and regulatory problems.

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How to Prepare for a GMP Audit

Review the scope of the GMP audit 

Review in advance the coverage of the audit, such as the locations and processes to be audited, as well as the timeframe needed by the auditors.

Communicate the audit plan to your team

Make sure that the plan is communicated to all site personnel, especially those whose areas will be audited. Clearly list the areas / systems / products to be audited and list
specific dates for each of the audits. 

Know  which standards are covered

Identify which standards will be covered in the GMP audit.  Audit standards may include:

  • Applicable policies
  • Laws and regulations
  • Procedures
  • Management system requirement; or
  • Contractual agreement with suppliers

Be sure that you are precisely familiar with the standards and any policies regarding their explanation and application.

Know your documents and prepare them ahead of time

Prior to the audit, ensure that your team has reviewed any documentation that an auditor is likely to request. Make sure that all documentation is accessible and that all circulated documents are ‘controlled copies’ and up-to-date.

The documentation may include:

  • Relevant management system documents and records
  • Applicable standards
  • Site master file
  • Training records
  • SOP’s
  • Previous audit reports

Typically, the auditor will review the following documents before arriving on your site:  Site Master File (if the auditor is new to your site)  Validation Master Plan previous audit findings and your responses complaints and adverse events. 

Define tour routes

 It will be helpful to establish routes through the facility to have an efficient GMP audit. Ensure that your auditees are assigned in areas and are capable of answering auditors’ questions. 

Auditing Tool for GMP Compliance

Conduct a thorough and systematic GMP audit using a digital checklist. Use iAuditor, the world’s #1 inspection app, to replace existing workflows involving paper forms, spreadsheets, scanning and faxing, and perform audits on your mobile phone or tablet. With iAuditor you can:

  • Create mobile-ready GMP audit checklists
  • Empower teams to complete GMP audits using a smartphone or tablet
  • Attach photos and make annotations within the app
  • Save all reports online. Preview a sample report here.
  • Use for free with small teams. Unlimited reports and storage for premium accounts Compare pricing plans.

Author

John Derick Flores

SafetyCulture Staff Writer

Dirk is a contributing writer for SafetyCulture who has 3+ years of experience being a Safety Officer in an international airline. Over the course of his tenure, he worked on projects involving training management, ramp safety inspections, quality & safety certification audits, and safety promotion programs. Further, he is interested in maximizing the power of technology to help make the world a better place.