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Thursday, December 22, 2022

Requirements of 21 CFR Part 820.100 corrective and preventive actions. Medical Devices

U S FDA Regulatory guidelines on corrective and preventive action in a pharmaceutical manufacturing firm. CAPA requirements of regulatory agencies.

Requirements of 21 CFR Part 820.100 corrective and preventive actions. Medical Devices.

Pharmaceutical manufacturing firms must have a well organized system to establish and maintain procedures for efficient implementation of CAPA procedures adapted to cover following areas. Evaluate processes manufacturing operations and other operations, Internal audit findings, QMS records, Market complaints, incidences, deviations, recalled batches, and system to gather information and data for potential root causes for nonconforming product or deviations or incidences. Statistical approach is required to be given to identify the repeated non-conformance, and their root causes. Analysis should be done by comparing the data gathered from the same non-conformances.

Data of all non-conformance should be gathered and statistical approach must be given to analyse the problems and root causes. Therefore, Investigation of root cause with proper focused methods is required. Identify the corrective actions and preventive actions required based on the identified root causes. Characterize the non conformance. Following could be the root causes.

Training 2) Design 3) Manufacturing, Management, change control, inferior quality material, improper documentation, testing, and maintenance.

Many pharmaceutical manufacturers use training as the root cause instead of other genuine root because which is again harmful. Therefore, proper tools must be used to investigate root causes of non conformance and market complaints.

Fish bone analysis, Brainstorming sessions, 5 why tool, you may extend a number of questions till you arrive at a justifiable answer leading to the root cause.

Verify and validate that corrective and preventive actions taken are sufficient to prevent the same non-conformance. Implement and document the changes done to eliminate the root causes of non conformance. Inform all stakeholders regarding the root cause and the actions taken to eliminate the same, train them. It is mandatory to submit the same for management review. All actions taken are required to be systematically documented with evidence.

US FDA during their inspections check how a manufacturing firm categorizes and arranges the data for investigation and evaluation for root cause and corrective and preventive actions.

Source: 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.100

https://timesofpharma.com/handling-investigation-market-complaint-drug-product/

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