
CAPA in the Pharmaceutical and Biotech Industries
How to Implement an Effective Nine Step Program
Description
Key Features
- Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action
- Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail
- Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately
Readership
Table of Contents
1. Understanding the FDA’s CAPA requirements and regulations
- Part I. 21 CFR part 820.100 for medical devices
- Part II. 21 CFR Part 211: current good manufacturing practice for finished pharmaceuticals
- Part III. The FDA’s current inspectional approaches
- Part IV. QSIT and CAPA: inspectional objectives
- Part V. Quality systems approach to pharmaceutical current good manufacturing practice regulation, September 2006
- Part VI. ISO 13485 and CAPA: inspectional objectives
- Summary to part VI
2. Implementing a CAPA program: Going back to basics
- Corrective and preventive actions
- General requirements
- CAPA process
- Correction/remedial action
- Evaluation of risk
- CAPA process metrics
- Closed-loop corrective action
3. The nine-step CAPA program
- The nine-step process
4. Step 1: identification of the event and writing a proper problem statement
- Write a detailed problem statement
- Use the “Ws” and “Hs”
- Step 1: identification of the problem and effective compliance writing
- Scenario 1
- Scenario 2
- Root cause analysis: methods, whys, and the fishbone diagram
- Understanding the problem statement and the evaluation of the event
- Seeking quality data
- Document the problem
- Explanation of the problem
- Evidence
- Evaluation
- More on report writing
- Summary
5. Step 2: risk assessment and impact assessment
- Why include risk analysis in CAPA programs?
- What it means to integrate risk analysis into CAPA
- Evaluation
- Assessment of risk
- Risk-management process
- The level of investigations, and the extent of corrective and preventive actions
- Some important definitions related to risk
- Maintenance of risk-analysis results/worksheets/forms
- Summary
6. Step 3: evaluate event and initiate remedial actions (correction)
- Part I. Internal corrections
- Part II. Corrections and removals (external corrections)
- Responsibilities
- General requirements
- Recalled/recovered product disposition
- FDA reportable field action
- Nonreportable field actions
7. Step 4: data gathering and analysis
- Potential causes and data collection and analysis
- Data, quality indicators, and triggers
- Levels of reviews
- Data collection should be planned as follows
- Data analysis and the investigation process
- Data collection
- Potential causes and data collection and analysis
- Results and data
- CAPA system data collection and analysis
- The general process for data collection and analysis
- CAPA system review
- Problem analysis
- Improvement
- Investigation process metrics
- Closed loop corrective action
8. Step 5: investigation
- When investigation is needed
- Information may not be completely accurate or reliable
- Responsibilities/resources
- Internal data sources
- External data sources
- Introduction of the investigation process
- Investigation initiation
- Investigation owner and team designation
- Team constitution
- Investigation methodologies definition/selection
- Investigation plan elaboration
- Investigation plan approval
- Execution of the investigation
- Potential causes and data collection and analysis
- Results and data
- Problem analysis
- Investigation results submission
- The risk evaluation update
- Investigation results approval
- The investigation owner is responsible for the following:
- The CAPA coordinator is responsible for the following:
- Ensure accurate documentation
- Step 5: investigation part II: out of specification
- Investigating and assessing OOS results—principles of failure investigation
- Step 5: investigation part III—complaint investigation
9. Step 6: part I—root cause analysis
- Outcome
- How to conduct an RCA and the RCA team
- Definition of the problem
- Gathering relevant data
- Cause/effect analysis
- Open issues/notes
- Action plan
- RCA assessment and maintenance
- Part II: RCA tools
- Philosophy of RCA
- Symptom approach versus root cause
- How do we do RCA?
- RCA major steps
- RCA process charting
- Typical checklist for aspects to be considered when doing the RCA
- Barrier analysis
- Barrier analysis: pros and cons
- Definitions
- Change analysis
- Definitions
- Pros and cons
- Discussion
- What is a suitable basis for comparison?
- The purpose of change analysis
- Brainstorming
- Brainstorming guidelines
- Fishbone diagram
- What does it look like?
- How is it done?
- Guidelines
- People
- Machines
- Measurement
- Material
- Environment
- Methods
- Methods
- 5W techniques or why diagram
- Control charts
- Types of variation
- Types of variation
- Check sheets can be used to gather and group data
- Pareto analysis
- It is critical to determine the whys?
- Mistakes do not just happen
- Preventing human error
- Error proofing: 5S methodology
- Continuous improvement models: 5S
- Human error assessment and reduction technique
- Part III: example of investigation tools for why diagrams and fault tree diagrams
- Containment/correction
- Investigation plan
- Investigation elements
- Summary of root/contributing causes
- Investigation and root cause conclusion
10. Step 7: corrective and preventive action plans
- Completing corrective/preventive action plans
11. Step 8: implement and follow-up on action plans
- Action plans
- Execution of the CAPA plan
- Follow-up action plan
- Follow-up: a fundamental step in the CAPA process
- Upon completion of each corrective action/preventive action
- CAPA and change control
- Classification of the change
12. Step 9: verification of effectiveness
- Verification/effectiveness of the actions
- CAPA verification of effectiveness plan
- Conclusion
13. Examples of procedures
- Procedure example #1. SOP: control of nonconforming product
- Procedure example #2. OOS: SOP
- Procedure example #3. SOP: corrective and preventive
- Procedure example #4. SOP: FMEA SOP
- Procedure example #5. OP: RCA
- Procedure example #6. SOP: quality system data analysis
Conclusion: requirements for an effective CAPA program
Product details
- No. of pages: 248
- Language: English
- Copyright: © Woodhead Publishing 2015
- Published: November 15, 2015
- Imprint: Woodhead Publishing
- Hardcover ISBN: 9781907568589
- eBook ISBN: 9781908818379
About the Author
J Rodriguez
Affiliations and Expertise
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