Learn how to write a SOP for corrective and preventive actions (CAPA) in quality management to ensure compliance and implement effective solutions to prevent issues.
1. PURPOSE
To describe the process for identifying, documenting, evaluating, and implementing corrective and preventive actions to address non-conformities and potential non-conformities in the pharmaceutical industry.
2. SCOPE
This SOP is applicable to all departments involved in the manufacture, quality control, quality assurance, and distribution of pharmaceutical products.
3. ASSOCIATED DOCUMENTS
WHO Guideline on Quality Vol. 2.2004
4. RESPONSIBILITIES
4.1 The concerned department head is responsible for reporting deviations, taking immediate
preventative measures, investigating reasons, and developing an action plan.
4.2 The Quality Assurance executive/officer is responsible for putting remark on deviation findings in
the corresponding log book and provide the report number.
4.3 Quality Control is responsible for re-analyzing and issuing status labels as appropriate.
4.4 The head of the QA is responsible for making final decisions on deviations and approving
CAPAs.
5. ACCOUNTABILITY
Head of Quality Assurance Department
6. PRECAUTIONS
Not Applicable
7. PROCEDURE
7.1 First identify and report non-conformities or potential non-conformities using the CAPA request form.
7.2 After receiving the non-conformity or the non-conformity was detected, Quality Assurance Head has to justify the non-conformity to do a corrective and preventive action.
7.3The source of non-conformity are as follows :
GMP Investigations
Deviations
Laboratory Investigations
Internal Audit Reports
External/ Customer Audits
Annual Product Reviews
Regulatory Inspection Reports
Management Action Plans
Changes in regulatory/ Pharmacopeia requirements
Product Failures
Complaints
Product recall
Returned Goods
Incidence reports
Discrepancies
7.4 The CAPA request form should include details such as the description of the issue, date of occurrence, and initial assessment. Follow Annex-1.
7.4.1 The CAPA shall be numbered serially in the calendar year for each department with an identification code of department. A typical Corrective and Preventive Action form shall be numbered as CAPA/X/Y/Z
Where,
X: department code.
Y: serial number, commencing at 001 for each department in the calendar year.
Z: Last two digits of a calendar year.
Example: CAPA/PRO/001/24 represents the 1st Corrective and Preventive Action from production department in the calendar year 2024
7.5 The QA Manager and relevant department head will evaluate the reported non-conformity.
7.6 A risk assessment will be conducted to determine the severity and impact of the non-conformity on product quality and patient safety.
7.7 A root cause analysis will be performed using appropriate tools (e.g., Fishbone diagram, 5 Whys) to identify the underlying cause of the non-conformity.
7.8 The findings of the root cause analysis will be documented.
7.9 Based on the root cause analysis, an action plan will be developed to address the root cause.
7.10 The action plan will include corrective actions to address the current non-conformity and preventive actions to prevent recurrence.
7.11 The CAPA Coordinator will assign responsibilities for the implementation of the action plan.
7.12 The assigned personnel will implement the corrective and preventive actions within the agreed timeline.
7.13 After the implementation of actions, the QA Manager will verify the effectiveness of the Corrective and Preventive Action.
7.14 Verification may include additional inspections, tests, or audits to ensure the non-conformity has been effectively addressed.
7.15 The CAPA Coordinator will document all activities related to the CAPA in the CAPA log book.
7.16 Once the QA Manager is satisfied and meet up all specifications with the effectiveness of the actions taken, the CAPA will be closed.
7.17 Follow-up audits may be scheduled to ensure long-term effectiveness of the implemented actions.
7.18 Trends in non-conformities and CAPAs will be reviewed periodically to identify areas for continuous improvement.
8. DEFINITIONS/ ABBREVIATIONS
8.1 Corrective Action: Action taken to eliminate the cause of a detected non-conformity or other undesirable situation.
8.2 Preventive Action: Action taken to eliminate the cause of a potential non-conformity or other undesirable potential situation.
8.3 Non-conformity: Non-fulfillment of a requirement.
8.4 SOP: Standard Operating Procedure
8.5 CAPA: Corrective Action and Preventive Action
8.6 WHO: World Health Organization
8.7 QA: Quality Assurance
8.9 GMP: Good Manufacturing Practice
8.0 ANNEXURES
8.1 Annexure-1: Corrective Action and Preventive Action Form
8.2 Annexure-2: Log Book for Corrective and Preventive Action
9.0 REVISION HISTORY
| Version | Effective date | Description of the Changes |
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the Bangladeshi pharmaceutical blogger since 2019.
