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CAPA pocess required for correction and pevention of problem.


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A.I.S.S.M.S. College of pharmacy, Pune-01 CORRECTIVE & PREVENTIVE ACTION Presented By: Mr. Vishal A. Tayade Guided by : Mrs. Dr. M.C. Damle Department of Quality Assurance For subject : Advanced Quality Assurance Technique 16 October 2015 1

Contents ::

Contents : Corrective Actions Preventive Actions Application of Corrective and Preventive Actions System CAPA process with examples Formats References 16 October 2015 2

Corrective Action :

Corrective Action Corrective action is aiming to correct an existing non-conformity and to avoid reoccurrence of the same non-conformity. Corrective action may arise e.g. from manufacturing deviation, complaints, audit findings, recalls. 16 October 2015 3


A systematic investigation should be performed to determine the reason(s) for the non-conformities and to agree upon appropriate corrective action. In the frame of the management review, management should be notified about the costs and impact of failure including the respective corrective actions . 16 October 2015 4

Preventive Action :

Preventive Action Preventive action is aiming to avoid the initial occurrence of a non-conformity by proactively implementing improvements . Preventive action may result i.e. from trending of in process data, of analytical data, of audit findings, trending of root causes for non-conformities or complaints, from product quality reviews, quality risk analyses, etc. 16 October 2015 5

Application of Corrective Action and Preventive Action System throughout the Product Lifecycle. :

Application of Corrective Action and Preventive Action System throughout the Product Lifecycle. Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation     Product or process variability is explored. CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process.     CAPA can be used as an effective system for feedback, feed forward and continual improvement.     CAPA should be used and the effectiveness of the actions should be evaluated.     CAPA should continue after the product is discontinued. The impact on product remaining on the market should be considered   16 October 2015 6

CAPA Process :

CAPA Process 1. Identification: Define the problem 2 . Impact / Risk Assessment: Initial assessment of the impact and the magnitude of the problem . 3. Immediate Action: Protect the customer from the problem . 4. Root Cause Investigation: Identify the root cause of the problem by using a systematic approach. 16 October 2015 7


Conti ….. 5. Conclusion and Quality Decision: Final thorough conclusion on the impact and magnitude of the problem, decision regarding the use of the product, etc. 6 . Action Plan: corrective and preventive actions. 7 . Implementation and Follow-up: Implement corrective and preventive actions and verify their effectiveness. 16 October 2015 8

1. Identification :

1. Identification To enable an efficient root cause investigation, the problem has to be clearly defined. Collect all available information, ask questions: Who, when, what, why, how. Summarize the problem in a detailed and concise description. Example : The stability of product XYZ failed . The assay result of the 24 months stability time point of batch 123456 of product XYZ is out of specification. Specification: 95.0 % 105.0 %, Result: 93.4 % 16 October 2015 9

2. Impact / Risk Assessment :

2. Impact / Risk Assessment The problem must be evaluated to determine the need for immediate, corrective and preventive actions and the level of action required, based on the impact and risk of the problem. The evaluation should include : Potential Impact of the problem. Risk to its customers and/or the company (i.e. risk to the patient related to the quality, efficacy or safety of the product; risk for the reputation of the company; risk of; financial risk)Immediate action that may be required 16 October 2015 10

3. Immediate Action :

3. Immediate Action Immediate action is necessary, when the quality, efficacy or safety may be compromised by the problem. Examples for immediate action : Product recall Rejection of a batch Interruption of the production 16 October 2015 11

4. Root Cause Investigation :

4. Root Cause Investigation A systematic approach should be applied to ensure that no potential root cause is lost. List all potential root causes and evaluate their likelihood. If more than one root cause is likely, a stimulation of the potential root cause can help to prove the root cause. 16 October 2015 12


Finding the primary root cause is essential for determining appropriate corrective and/or preventive actions . 16 October 2015 13

5. Conclusion and Quality Decision :

5. Conclusion and Quality Decision Summarize the identified root cause(s ). Summarize the impact and the risk for the customer and/or company. T he quality decision, i.e . No impact of the deviation on the product quality, efficacy or safety. Product is rejected due to major impact of the failure on product quality . Product is recalled. 16 October 2015 14

6. Action Plan :

6. Action Plan Based on the result of the root cause analysis, all tasks required to correct the problem and prevent a reoccurrence are identified and included in an action plan. The plan assigns responsibilities and due dates for implementation. Enough detail must be included regarding the required action and the expected outcome. Pay attention on correct order of activities. 16 October 2015 15

7. Implementation and Follow-up :

7. Implementation and Follow-up The Action Plan is executed and all tasks are completed . The actions that were taken are documented. The appropriateness and effectiveness of the actions taken is evaluated: – Have all recommended changes been completed and verified? – Have all objectives been met? 16 October 2015 16


Has training been performed to ensure that all affected employees understand the changes that have been made? Was an assessment made that the actions taken have not had an adverse effect on other properties or aspects of a product or process. Closure of CAPA after successful implementation. 16 October 2015 17

Examples ::

Examples : Description of the problem: The filling silicone tubing (machine to filling of empty glass barrels), which contains silicone oil to wet the glass barrels of the empty syringes, did have small cracks; therefore the volume of the siliconizing solution applied to the glass barrel was too small, which resulted in enhanced friction for the administration of the drug product. 16 October 2015 18

Result of the initial investigation and CAPA:

Result of the initial investigation and CAPA Several months earlier, a similar issue happened on the same machine, but with the supply silicone tubing containing silicone oil; QA and production experts did not apply a systematic root cause analysis, but suggested to implement a 1-year shelf–life for the tubing based on individual experience. Repetition of the investigation (problem): Since the issue occurred already twice, it was decided to apply a systematic root cause analysis. 16 October 2015 19

Systematic root cause investigation and CAPA:

Systematic root cause investigation and CAPA Systematic root cause investigation : Collection of all available information (e.g. IPC-control may be inadequate, possible shedding of silicone particles into glass barrels, silicone type) Confirmation of likely root cause; shelf life of silicone tubing not adequate for this purpose. Confirmed root cause after consultation with the supplier of the silicone tubing CAPA Shelf life of silicone tubing not adequate for this purpose; implementation of more stringent preventive measures (quarterly change of silicone tubing, silicone change date documented in individual executed batch record), monitoring of discrepancies on this machine for one year, if issue happens again. 16 October 2015 20


Result: Appropriate CAPA identified and implemented; issue did not happen again. 16 October 2015 21


Formats 16 October 2015 22


REFEENCES : 1] ICH Harmonized Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 4 June 2008, this guideline is recommended for adoption to the three regulatory parties to ICH. Pg. no. 9 2] Quality and GMP June 2012. Ms. Marlisa Giger Pharmacy Museum, Totengasslein 3, 4051 Basel 3] 21 CFR Part 820 – search cfm? CFR Part=820 16 October 2015 23


4]Preamble to the QS Regulation Final Rule – Regulation and Guidance/Post market Requirements/ Quality Systems Regulations/ Medical Device Quality Systems Manual / UCM122806.pdf 16 October 2015 24


THANK YOU 16 October 2015 25

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