Corrective Actions &
Preventive Actions
(CAPA)
z
Pharmacist Profession Program
Pharmacy Faculty of Pancasila University
Jakarta
Introduction
• CAPA is a part of Pharmaceuticals Quality System
• Company should have a system for implementing
CAPA
• CAPA methodology should result in product and
process improvements and enhanced product
and process understanding.
CAPA on PQS
• An appropriate level of root cause analysis, should be
applied during investigation of deviations, suspected
product defects and other problems.
• Where human error is suspected/identified as the
cause, this should be justified having taken care to
ensure that process, procedural/system based errors
or problems have not been overlooked, if present
CAPA Application during Life cycle
Pharmaceutical Transfer Commercial Product
development Technology Manufacturing Discontinuation
Variabilitas produk CAPA dapat CAPA harus CAPA dilanjutkan
atau proses digunakan sebagai digunakan dan sampai produk
eksplorasi suatu system yang efektifitasnya harus ditetapkan untuk
Metoda CAPA efektif untuk dievaluasi tidak diteruskan
berguna, dimana umpan balik, dan penjualannya.
CA dan PA continual Dampak terhadap
dimasukkan ke improvement sisa produk di pasar
dalam desain dan dan produk-produk
proses lain yang mungkin
pengembangan terkena dampak
yang berulang juga harus
dipertimbangkan
Solutions
Triggers Non-conformity
(deviation, OOS)
CAPA
Complaint
Document
Control
Risk
Audit Finding
Assessment
Change
Control
Trending, Quality
Review
Training
Recall
Preventive vs Risk Management
Risk Product/Services
Design Assessment meet requirement
Risk Reduction
Keyword : new product/services
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 deviations,
OOS investigations, complaints, audit findings, recalls.
• A systematic investigation should be performed to determine the
reason(s) for the non-conformities and to agree upon appropriate
corrective action.
• Agreed corrective actions should be closely followed-
up and monitored until their completion.
• In the frame of the management review, management
should be notified about the costs and impact of failure
including the respective corrective actions.
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 (annual product reviews), quality
risk analyses, etc.
Preventive Action
• Similar to corrective actions, agreed preventive actions should
be closely followed-up and monitored until their completion.
Effectiveness of preventive actions should be reviewed
regularly, i.e. as part of the product quality review (annual
product review).
• Information regarding preventive actions including costs and
cost savings should be regularly subject to management review
in support of maintaining and improving the effectiveness of the
Quality Management System.
CAPA Process
Identification • Define the problem
Impact/risk
assessment
Immediate • Protect costumer from
action problem
Root cause • Using systematic approach
investigation
Conclusion &
Quality Decision
Action Plan
Implement and
Follow Up
CAPA Mindset
Open mind & Structured
Responsive
Risk Based Technique
Logic & Scientific Based Approach
Prevent Repeatation
Identification
To enable an efficient root cause investigation,
the problem has to be clearly defined.
1. Collect all available information, ask
questions: Who, when, what, why, how
2. Summarize the problem in a detailed and
concise description.
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:
a) Potential Impact of the problem.
b) 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 adverse regulatory actions; financial risk)
c) Immediate action that may be required
Immediate Action
Immediate action is necessary, when the
quality, efficacy or safety may be compromised
by the problem.
Examples for immediate action:
Product recall
Blockage of the stock of a product
Rejection of a batch
Interruption of the production (i.e. until
problem is assessed and fixed)
Root Cause Investigation
A systematic approach should be applied to
ensure that no potential root cause is lost through
focusing only on a few assumed root causes. Tools
can be applied to facilitate the investigation, i.e.:
Start with a brainstorming, i.e. using an Ishikawa
diagram (fishbone or cause and effect diagram)
Root Cause Analysis
Source : ISPE Indonesia Affiliate
Conclusion and Quality Decision
Summarize the identified root cause(s).
Summarize the impact and the risk for the
customer and/or company.
Document the quality decision, i.e.
a) No impact of the deviation on the product
quality, efficacy or safety – product can be
released.
b) Product is rejected due to major impact of the
failure on product quality.
c) Product is recalled.
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.
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?
₪ 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.
CAPA Challenges
• One of the most fundamental steps in the
CAPA process is completing an evaluation of
the actions that were taken.
• This evaluation must not only verify the
successful completion of the identified tasks,
but also assess and adequately document the
appropriateness and effectiveness of the
actions taken.
