CAPA Reviews being regularly used? If so; why is it that Corrective and
Prevention action procedures continue to be a major source of 483
observations. The majority
of companies claim to have fully functioning systems in use and yet FDA
audits regularly find these systems are either partially or incorrectly
How can companies proactively
address these regulatory deficiencies?
The FDA and regulators world-wide require manufacturers of pharmaceutical, biological and medical devices not only to have a procedure (CAPA) in use; but to regularly execute reviews that will identify, instigate investigation, and report on deficient or failure within the system. These compliance reviews and all relevant records of compliance verification should be retain for regulatory review.
Having such a system recording and instigating investigation into all reported defects not only helps companies fulfill their regulatory obligations, but also helps prevent new problems from arising, and known problems from re-occurring. Poor CAPA systems remain one of the top problem areas for both the drug and device industries when it comes to FDA inspections. And citations account for more than 50 percent of FDA warning letters.
This CAPA review document has been prepared to enable your system to be easily assessed for compliance with the requirements. As part of the CAPA functionality, individual users complete action tasks by providing input and/or results, and managers approve the overall CAPA process. Similarly, the CAPA review process enables quality managers to schedule audits and track their progress and results. Individual contributors can provide responses, enabling the entire team to multi-task and facilitate an in-progress review. Quality Improvement Central is intended to provide a powerful, yet simple solution for managing quality while maintaining tight process inter-operability with other aspects of the product life-cycle.
Management must ensure and be involved in a review and confirmation that actions taken were effective and did not introduce new issues or concerns. The following questions should be considered at appropriate times throughout the process and be revisited in the final review:
Has the improvement action(s) been defined, planned, documented,
verified and implemented?
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
CAPA methodology should result in product and process improvements and enhanced product and process understanding.
Q9 & Q10; are not intended to create any new expectations beyond
current regulatory requirements. Consequently, the content of ICH Q9
& 10 that are additional to current regional Good Manufacturing Practice (cGMP) requirements are
You want to validate a process line or new process equipment or individual process assembly stage equipment or just similar equipment that requires equipment qualification after having been subjected to major modification.
In this case you require the following validation protocols
VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 2 Package consists of one of each of these.
This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical Equipment qualification and software controlled, monitored or driven systems.
This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities. The VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records & equipment qualification.