Learn SOP for preparation of rejection note in pharmaceutical QC including format, approval, and documentation for rejected raw and packing materials.
Introduction
In pharmaceutical manufacturing, ensuring that only compliant materials are used is critical for product quality and regulatory compliance. When raw materials or packaging materials fail to meet quality specifications, they must be formally rejected and documented.
A rejection note serves as an official document confirming that the material does not meet quality standards and should not be used. This SOP outlines a structured, GMP-compliant procedure for preparing and issuing rejection notes in the Quality Control department.
Definition
Rejection note in pharmaceutical QC is an official document issued by the Quality Control department to declare that a material has failed to meet specified quality parameters and is not approved for use.
| Element | Description |
|---|---|
| Material Details | Name, batch number, supplier |
| Test Results | Analytical findings |
| Reason for Rejection | Non-compliance details |
| Authorization | QC and QA approval |
| Distribution | Copies to relevant departments |
| Record Retention | QC documentation archive |
Step-by-Step Process
- Identify material failure
- Verify test results
- Obtain Quality Head approval
- Prepare rejection note in approved format
- Distribute copies to departments
- Get QA authorization
- File and maintain records
1.0 OBJECTIVE
To lay down the procedure for preparation of Rejection Note.
2.0 SCOPE
This SOP is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer – Quality Control
4.0 ACCOUNTABILITY
Sr. Manager – Quality Assurance
5.0 PROCEDURE
5.1 Authorization of Rejection
- Rejection of raw or packing material shall be based on QC analysis
- Approval must be obtained from Quality Head
5.2 Preparation of Rejection Note (Operation)
- Prepare rejection note using approved format
- Include:
- Material name
- Batch number
- Supplier details
- Test results
- Reason for rejection
5.3 Distribution of Rejection Note
Prepare rejection note in multiple copies:
- Stores Department – for inventory control
- General Manager (Materials) – for procurement action
- Quality Control Records – for documentation
5.4 Approval and Authorization
- Rejection note must be authorized by QA Head
- Ensure signatures and dates are recorded
5.5 Documentation and Record Keeping
- Maintain copy in QC records
- Ensure traceability of rejected materials
- Link with batch documentation
5.6 Calibration / Compliance
- Ensure analytical instruments used were calibrated
- Verify test results before rejection decision
- Follow GMP documentation practices
5.7 Cleaning / Data Integrity
- Maintain clean and legible records
- Follow ALCOA+ principles
- Avoid overwriting or unauthorized changes
6.0 ABBREVIATIONS
- SOP – Standard Operating Procedure
- QA – Quality Assurance
- QC – Quality Control
- Dept. – Department
Technical Insight: Importance of Rejection Note
Rejection notes ensure that substandard materials are not used in production, protecting product quality and patient safety. They also provide traceability and support regulatory audits.
FAQs
1. What is rejection note in QC?
A document declaring material failure.
2. Who prepares rejection note?
QC Officer.
3. Who approves rejection note?
QA Head.
4. Why rejection note is important?
Ensures only approved materials are used.
5. What materials can be rejected?
Raw and packing materials.
6. What is included in rejection note?
Material details, test results, reason. https://iampharmacist.com/out-of-specification/
7. How many copies are required?
Typically three.
8. Where is rejection note stored?
QC records.
9. What guidelines apply?
GMP and QA procedures.
10. What happens after rejection?
Material is quarantined or returned.
