by 1.0 OBJECTIVE
To lay down the procedure to be followed for the administration of corrective and preventive actions (CAPA) including tracking and reporting of the status of CAPA.
2.0 SCOPE
This SOP is applicable to all the CAPA requirements arising out of a particular observation in the plant.
Corrective Action: The action was taken to rectify, fix or correct a specific deviation, defect or undesirable situation.
Preventive Action: The action was taken to eliminate the cause of deviation, defect or undesirable situation in order to prevent the future occurrence of such or similar and event.
Source documents of CAPA are identified as:
- GMP Investigations
- Deviations
- Laboratory(OOS) Investigations
- Internal /Customers Audits
- Annual Product Review
- Regulatory Inspection Reports
- Management action plans’
- Changes in regulatory/Pharmacopoeia requirement
- Product Failures
- Complaints
- Product Recall
- Returned Goods
- Incident Reports
- Discrepancies
- 3.0 RESPONSIBILITY
All Department Head
4.0 ACCOUNTABILITY
Head Quality Assurance
5.0 PROCEDURE:
5.1 Source document shall provide the proposed corrective and preventive actions. The proposed corrective and preventive actions shall be approved by QA prior to implementation. The proposed corrective and preventive actions shall be verified during CAPA evaluation form.
5.2 The CAPA form shall be treated as a tracking form of corrective and preventive actions form the source documents.
5.3 Initiation of CAPA
5.3.1 Department head shall decide the need for CAPA during initiation of any source document mentioned in scope.
5.3.2 Department head shall get a CAPA form issued from QA. QA shall write the source document name and source document number on the form before the issue of form. Record of CAPA form issued shall be maintained by QA.
5.3.3 Department head shall fill the CAPA form as under.
5.3.3.1 Write the name of the department.
5.3.3.2 Date CAPA initiated.
5.3.3.3 Proposed completion date.
5.3.4 Carry out root cause analysis and write the description based on the source document.
5.3.5 Write in brief the CAPA description from the source document and corrective and preventive action details.
5.3.6 The department head shall write their name with signature and date.
5.3.7 The department head shall send the CAPA form to QA.
5.3.8 QA shall allot a reference number to the CAPA form and make relevant entries in the CAPA log. Forwarded the CAPA form to the concerned department.
5.3.9 The CAPA shall be numbered serially in the calendar year for each department with an identification code of department. A typical CAPA form shall be numbered as.
CAPA/DC/YY/MM/XXX
Where, CAPA- Corrective and preventive action
DC – Department Code
YY – last 2 digit of current Year (19 for 2019, 20 for 2020)
MM – Month (01 for Jan., 02 for February, 03 for March………………….12 for Dec.)
XXX – Serial Number of the CAPA in respective month.
Example:
The first CAPA occurring in the Quality Control Department in month of March 2019
Shall be numbered as: CAPA/QC/19/03/001.
5.4 CAPA Closure and Verification:
5.4.1 On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
5.4.2 QA shall verify the implementation and completion of CAPA with review of supporting documents and certify the same.
5.5 Any change proposed as result of CAPA shall through the SOP on change control. Reference of the same shall be mentioned in the CAPA format.
5.6 All Deviations, Discrepancy reports giving rise to CAPA shall be addressed through CAPA form.
5.7 All facility up-gradations / capital purchase requirement/major changes in quality system for compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.
5.8 The record of each CAPA shall be maintained.
5.9 Department head shall compile the CAPA information and submit the summary to Quality assurance department.
5.10 Quality Assurance reviews the CAPA.
5.11 Based on the comments and evaluation Head QA or his designee shall approve/ reject the CAPA.
5.12 Trending of CAPA:
5.12.1 Continuous trending of the CAPA shall be carried out.
5.12.2 QA shall carry out the trend analysis for all the whole year CAPA, at the beginning of the next year. A copy of trend analysis shall be forwarded to Head Quality.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
