7-纠正措施与预防措施CAPA(英)

CORRECT APPROACH
• It is essential that CAPA actions should be efficient (adequate correction from the beginning) and rapid (action within a reasonable time) • CAPA is very important to regulatory authorities and will be audited as such. • The problem is often that companies/departments are afraid to face the fact that there are problems, so that they are ignored, or people are afraid to report them • Problems/deviations should not be accepted, but are unavoidable
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CORRECT APPROACH
• A successful CAPA implementation needs an efficient and strong organisation. • It is tempting to adopt the philosophy “just do it !” or “just fix it quickly !” • This method (often very admired) leads to improvisation, is mainly oriented to the fixing of problems and does not lead to a real correction of problems, which should be • To find the real cause of the problem, • To define a corrective action in order … • To avoid the recurrence of the problem (preventive action)
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CAPA – SOLUTION STRATEGIES
How to best use the CAPA system?
1.Identify the issue, 2.Implement corrective action for the specific issue, 3.Implement a preventive action that will eliminate similar issues in future, and 4.Verify that the preventive action is effective by monitoring trend data in the future Warning letters indicate that step 3 is seldom done, while step 4 is almost never done
CORRECT APPROACH
• GMP rules recognize problems and errors, and this is why you will find complete chapters on those subjects: complaints, deviations, OOS, CAPA,… • Of course, the idea is not to list and classify problems, but to have a system to evidence them, to bring them to the attention of adequately trained personnel, so that they can be solved in a systematic and scientific way. • The problems can be found through appropriate systems (internal audits, complaints, handling of deviations, quality circles, risk analysis) or through external audits and inspections.
CONSIDERATIONS FOR CAPA PLANNING
• To find out the real cause of the problem • To determine the extent of the problem
(just one batch, just one product, or all batches and products on a machine ?)Fra bibliotek• • •
CAPA IMPLEMENTATION
• 21 CFR 820.100 (a) • The procedure shall include requirements for: • analyzing processes, • work operations, • quality audit reports, • quality records, • service records, • complaints, • returned products and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
CAPA – DEFINITIONS
According to International Organization for Standardization (ISO 8402),
A corrective action is one undertaken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence. A preventive action, is an action undertaken to eliminate the cause of a potential non-conformity, defect or other undesirable situation in order to prevent its occurrence.
CAPA PHILOSOPHY
• First, the quality system must have some prerequisite data collection systems already installed, such as: • rejected material reports, documented quality audits, • production and analytical data, • complaint data, • returned product reports and • any other reports pertinent to the activities of the quality program. • In order to be compliant, all the information being generated by the prerequisite data collection systems should be captured and trended. • The issues identified during the analysis of these data should be documented in Corrective Action(s).
CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) HOW TO SIMPLY COMPLY WITH GMP
Alain Kupferman, Industry Pharmacist
WHAT IS CAPA ?
Corrective and Preventive Action (CAPA) is a system of: Quality procedures required to eliminate the causes of
an existing nonconformity and
to prevent recurrence of:
o nonconforming product, o nonconforming processes, and o other quality problems.
Quality should be built into the product, and testing alone cannot be relied on to ensure product quality.
• To prevent recurrence at system level • To prevent recurrence at company level.
CAPA – SOLUTION STRATEGIES
Determining the right CAPA requires: – Imagination – instinct, – Experience – of handling failures, – Knowledge – of processes, procedures, laboratory systems, etc. – Training