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
- 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
- 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.
Best GMP Compliance Checklists
GMP Compliance Checklist
A GMP Compliance Checklist is used to evaluate a manufacturing company’s compliance with manufacturing protocols. Use this checklist to perform a facility walkthrough and manufacturing observation of all 8 relevant systems: 1) Building and Facilities; 2) Materials Management; 3) Quality Control Systems; 4) Manufacturing; 5) Packaging and Identification Labeling; 6) Quality Management Systems; 7) Personnel and Training; and 8) Purchasing and Customer Service. Use iAuditor for your GMP audits to:
- perform digital inspections/audits with your mobile phone or tablet;
- capture photo evidence of compliant and non-compliant items;
- add corrective actions for immediate resolution on identified non-compliant items;
- generate comprehensive reports as you finish an audit. Preview sample report here;
- save reports online and easily share it with members of your organization; and
- promote accountability for inspections done by capturing digital signatures.
GMP Food Manufacturing Audit Checklist
This GMP Food Manufacturing Audit is based on the 21 CFR Part 110 checklist and can be used as an assessment tool to ensure your organization follows manufacturing standards. Identify problem areas and assign immediate corrective actions by performing your food manufacturing audits with this template using the iAuditor mobile app. Securely save your completed reports in the cloud and track overall audit scores and performance.
GMP Site Walkthrough Checklist
A GMP Site Walkthrough Checklist is a tool used in conducting a full facility walkthrough and observation. Use this checklist to check a manufacturing site’s overall safety by assessing pest control, operational methods & practices, PPE, building & ground areas, and more. Identify and take photos of potential hazards and assign corrective actions to authorized personnel for immediate resolution.
FDA GMP Cosmetics Audit Checklist
This digital GMP Cosmetics Checklist has been built using the iAuditor app and based on the FDA’s GMP Cosmetic Guidelines. Use this digital GMP checklist to assess your manufacturing compliance with FDA guidelines across aspects of building and facilities, equipment, personnel, raw materials, production, lab controls, record keeping, labelling and complaints. Use iAuditor to take notes and photo evidence of non-compliance. Automatically calculate your audit score based on the responses and generate a complete report without leaving your manufacturing facility. Save all your reports securely in the cloud.
Good Distribution Practice (GDP) Self-Inspection Checklist
Use this GDP self inspection checklist to assess compliance with EU Good Distribution Practice guidelines. Conduct an audit of your facilities, systems and practices. This template covers questions across the areas of quality systems, personnel, premises and equipment, documentation, supplier operations, complaints & recalls and transportation. Calculate overall GDP compliance score across sections, identify frequently failing items and take photos and notes of non-compliance.