Improve GMP compliance by inspecting processes and operations using GMP audit checklists.
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 SafetyCulture for your GMP audits to:
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. A GMP audit should cover all the necessary procedures to collect valuable practices information such as supplier procedures, sanitary operations, premises, warehousing, and controls. Performing regular GMP compliance audits protects a business from product safety issues, product recalls, and legal and regulatory problems.
A GMP audit is a third-party audit conducted to assess if an organization is compliant with GMP regulations and industry standards on acceptable good manufacturing practices. It helps identify areas for improvement on GMP compliance and also provides guidance on how to become compliant.
Aside from general GMP checklists that businesses can use, employees are empowered to further ensure safety and hygiene in food manufacturing and across various industries using self-inspection checklists. This GMP Self Inspection Checklist is ideal for staff and employees that need to observe good manufacturing practices starting from their individual work. It also allows lone workers to systematically follow procedures and protocols even without direct supervision from higher-ups.
The ones primarily responsible for GMP compliance are those in the quality team, this includes executives such as chiefs of quality control, directors of quality, and facilities managers, or those directly involved in quality-specific jobs such as quality control inspectors and quality assurance managers. They are in charge of ensuring that GMP requirements, standards, and protocols are followed.
GMP audits are accomplished by certified auditors and regulated by agencies such as Food and Drug Administration (FDA), however, facilities are encouraged to do their own audits.
The basic principles of good manufacturing practices help ensure product quality is consistent and safe to use. Incorporating these will determine the scope and standards needed to pass GMP Auditing. The 10 principles of GMP are the following:
The FDA provides guidelines for a proper GMP inspection checklist. The Inspection Operations Manual provides specific guidelines per industry and type of goods manufactured. Products are restricted from entering the market if they are deemed to be contaminated or mislabeled. Strict compliance to good manufacturing practices prevents products from adulteration and misbranding. The following are factors that will be inspected during a 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.
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.
Identify which standards will be covered in the GMP audit. Audit standards may include:
Be sure that you are precisely familiar with the standards and any policies regarding their explanation and application.
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:
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.
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.
Conduct a thorough and systematic GMP audit using a digital checklist. Use SafetyCulture, 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 SafetyCulture you can:
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 SafetyCulture mobile app. Securely save your completed reports in the cloud and track overall audit scores and performance.
Use this GMP for food manufacturing industry to check the following:
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.
Inspection template Powered byThis digital GMP Cosmetics Checklist has been built using the SafetyCulture 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 SafetyCulture 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.
Inspection template Powered byUse 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.
Inspection template Powered byUse this self inspection checklist to inspect the following areas:
Jona Tarlengco is a content writer and researcher for SafetyCulture since 2018. She usually writes about safety and quality topics, contributing to the creation of well-researched articles. Her years of experience in one of the world’s leading business news organisations helps enrich the quality of the information in her work.
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 SafetyCulture mobile app. Securely save your completed reports in the cloud and track overall audit scores and performance. Use this GMP for food manufacturing industry to check the following: Current Good Manufacturing Practice Facility and Grounds Personnel Equipment Processes and Controls
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.
This digital GMP Cosmetics Checklist has been built using the SafetyCulture 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 SafetyCulture 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.
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.
Use this self inspection checklist to inspect the following areas: Hygiene Sanitary facilities Water and sewage Floors, walls, ceilings, lighting, and ventilation Equipment and utensils Washing Garbage and waste Pest control Items critical to food safety Good manufacturing and housekeeping
