Standard Operating Procedure for Handling of Rejects and Recalls in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish guidelines for the identification, handling, and disposition of rejected products and the management of recalls in the manufacturing of vaginal dosage forms.
2) Scope
This SOP applies to all personnel involved in the manufacturing, quality control, and quality assurance departments at [Company Name] responsible for handling rejects and recalls.
3) Responsibilities
Quality Assurance (QA) is responsible for overseeing the process of handling rejects and recalls. Production and Quality Control (QC) departments are responsible for implementing actions outlined in this SOP.
4) Procedure
4.1 Identification of Rejects
- Rejects are identified during in-process checks, final testing, or post-production inspection.
- Clearly label and segregate rejected products from acceptable batches.
4.2 Documentation and Reporting
- Document details of rejected batches including reasons for rejection, quantity, and batch number.
- Report rejects to QA for review and approval of further actions.
4.3 Disposition of Rejects
- Dispose of rejected products as per approved procedures (e.g., destruction, reprocessing).
- Ensure proper documentation of disposal activities.
4.4 Recall Management
- Initiate recall procedures promptly upon identification of a potential issue that may impact product quality or safety.
- Coordinate with regulatory affairs and communicate with relevant stakeholders (e.g., customers, regulatory authorities).
4.5 Corrective and Preventive Actions (CAPA)
- Investigate root causes of rejects and recalls.
- Implement CAPAs to prevent recurrence of similar issues.
5) Abbreviations, if any
QA: Quality Assurance; QC: Quality Control; SOP: Standard Operating Procedure; CAPA: Corrective and Preventive Actions
6) Documents, if any
Reject handling form, Recall initiation form, CAPA form
7) Reference, if any
ICH Q9: Quality Risk Management, WHO Technical Report Series No. 996, Annex 5: Guidelines on Good Manufacturing Practices for Sterile Pharmaceutical Products
8) SOP Version
Version 1.0