Top 5 Reasons to Establish When is Necessary a Quality Audit.

In this article, you will learn when is necessary a quality audit as per cGMP Good Manufacturing Practices.

An audit shall be done based on one or more of the following 5 triggers or reasons:

1. QA, supplier, or manufacturer recommendation,
2. Whenever a change is introduced to a process that may affect its operation, etc.
3. Risk evaluation of potential failures or FMEA analysis
4. Evaluation of the historical data.
5. Lapse of time for a re-audit.

More specifically, an audit must be performed on any process, area, equipment, or machinery related to the following areas:

• Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
• Packaging or labeling information, process, or materials.
• The shelf life of raw material, components, or finished products
• Process parameters
• Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
• Equipment or equipment settings
• Qualified cleanrooms
• Cleaning processes of the manufacturing environment or manufacturing equipment
• Facilities or utilities
• Locations for manufacturing, testing, sterilization, or warehousing
• Environmental conditions of manufacturing, testing, or storage,
• Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
• Suppliers or external manufacturers
• Line re-configuration as it relates to operators changing from a seated to standing position, updates to the line and station layouts, or re-sequencing of process steps
• Throughput time as it relates to changes to the material storage time between processes
• Product handling techniques as it relates to material storage and conveyance
• Working with multiple lots at different stations.
• Layouts in areas of product handling like manufacturing and warehouse
• Any change that can potentially impact form, fit, or function and the quality of the product.
• Changes related to supplied items, raw material, components, or finished products in regards to:
  • manufacturing or assembly processes
  • control or monitoring processes
  • cleaning processes
  • product handling
  • inspection or release processes
  • configuration check inspections
  • sample size or sampling plans
  • method of testing (e.g. physical, analytical, microbiological)
  • packaging or labeling processes
  • sterilization process
  • storage, shipment, or distribution processes.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES:

STATUTORY AND REGULATORY REQUIREMENTS

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.22

2 CFR § 200.501 – Audit requirements

httpss://www.law.cornell.edu/cfr/text/2/200.501

For more information about When is Necessary a Quality Audit, refer to:

httpss://www.intertek.com/auditing/gmp/

httpss://haccpmentor.com/gmp/gmp-audit/

httpss://ispe.org/initiatives/regulatory-resources/gmp/audit-considerations

httpss://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

httpss://www.fda.gov/media/90179/download

httpss://www.orielstat.com/blog/what-is-mdsap-certification/

httpss://www.bsigroup.com/en-US/medical-devices/Our-services/Medical-Device-Single-Audit-Program/

httpss://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-single-audit-program-mdsap