- OBJECTIVE :
To lay down a standard procedure for corrective and preventive action(s) system related to product quality / system attributes.
- SCOPE :
This SOP is applicable to all product quality / system attributes related
All product quality / system attributes related to to Sano Cito Therapeutics Inc. facility.
Deviations from established processes and procedures.
Short coming found – in self inspection, in external audits.
Any OOS results in Quality Control results.
Unusual events, incidents and accidents.
Unexpected results identified during the annual product review.
Market complaints.
- RESPONSIBILITY:
Production, Quality Control, Warehouse, Engineering, Quality Assurance shall be responsible to initiate, investigate the quality issue.
Quality Assurance shall be responsible to verify implementation of corrective and preventive action(s).
- ACCOUNTABILITY :
Department Head and QA Head shall be accountable for compliance of the procedure mentioned in this SOP.
- ATTACHMENTS:
Corrective and Preventive Action form – Attachment-I
CAPA register – Attachment-II
- PROCEDURE :
6.1. Definitions:
6.1.1 Corrective action:
Action taken to eliminate the root cause of an existing non – conformity, defect or other undesirable situation in order to prevent recurrence.
6.1.2 Preventive Action:
Action taken to eliminate the root cause of potential non-conformity, defect or other undesirable situation in order to prevent occurrence.
6.2 In case of any deviation (wherever applicable) or any abnormality as mentioned in scope, concerned department will inform QA department to issue the CAPA form (Attachment-I).
6.3 Each department shall record the details of product / quality attributes identified from any of above source in CAPA form.
6.4 All product quality / system attributes shall be identified and analysed. The source of product and quality problem could be following but not limited to –
- Incidents
- Technology transfer document
- Deviations (Planed / Unplanned)
- Annual product review
- Product complaints
- Change controls
- Out of Specification results
- Out of trends
- Risk assessment
- QC Stability reports
- Product recalls
- Ware housing
- Batch Failure
- Returned goods
- Self-Audits
- Other non – conformances
- Regulatory audit and commitments
- Audit by contract giver
6.5 QA Department should allot the CAPA No. and record the same in CAPA Log.
6.6 QA person makes entry into the log and allots CAPA control number which is made up as follows:
CYY/XX/XXX
1st character is C, which is abbreviation for CAPA.
2nd and 3rd characters are numerical which indicates last digit of current year.
4th character is “/”
5th and 6th characters are department code (for department code refer SOP “Document and Data Control” – SOP/QA/002)
7th character is “/”
8th, 9th and 10th characters are sequential number commencing from 001 for each department.
e.g. C19/PD/001 indicates CAPA belongs to Production department whose sequential number is 001 of year 2019.
6.7 Classify the relevant events based on their potential impact.
6.8 Major event:
6.8.1 An event, which may have an impact on product quality or on the information, which has been disclosed to regulatory authorities.
6.8.2 An event, which may affect multiple products or multiple lots of the same product.
6.8.3 An event, which may implicate already released product batches.
6.8.4 Repeated occurrences of the same minor events.
6.8.5 A major cGMP violation.
6.9 Minor event:
6.9.1 An event, with no or low impact on product quality.
6.9.2 An event, with no impact on information which has been filed with the authorities.
6.9.3 A procedural deviation where other supporting data exists.
6.9.4 An easily correctible issue by the originating department.
6.10 Record immediate remedial action, corrective actions, Investigation details, root cause identification, evaluation of remedial action on other sources followed by preventive action and their evaluation.
6.11 Based on the type of non – conformance, QA Head shall designate a team based on knowledge and skills, for carrying the investigation.
6.12 Carry out the investigation to identify the root cause, its impact on the product quality and other products / system and record in CAPA form.
6.13 Appropriate statistical and non-statistical techniques shall be used to analyze the impact on product quality / other systems.
6.14 Document all suggested corrective action(s) and preventive action(s) along with target completion date and responsibility.
6.15 Root cause should be identified on fact based & whenever possible supported with data.
6.16 Impact of the event should be identified on all the factors evaluated.
6.17 Timelines for CAPA procedures:
6.17.1 In case of Major events, the activity or product should not be taken before completing the CAPA procedure. The timelines for completing the major event is 15 days.
6.17.2 In case of Minor events, the timelines for completing the minor event is 30 days.
6.17.3 QA person shall verify all suggested corrective action(s) and evaluate preventive action(s) which are implemented in timely manner and documented appropriately.
6.17.4 All the CAPA related events should be regularly trended.
- REFERENCES:
PIC/S GMP Guideline – PE 009-10
- ABBREVIATIONS:
SOP: Standard Operating procedure
CAPA: Corrective and preventive action
QA: Quality Assurance
- DISTRIBUTUON LIST:
Quality Assurance
Quality Control
Production
Engineering
Warehouse
- HISTORY OF REVISION :
| Version No. | Effective Date | Reason for Revision |
