by 1.0 OBJECTIVE
To describe the procedure for review of Batch Processing and Control Record (BPCR).
2.0 SCOPE
This SOP is applicable for the executed BPCR of the products manufactured.
- RESPONSIBILITY
- Executive – Quality Assurance (QA) shall be responsible for:
- Review of the executed BPCR.
- Head – QA shall be responsible for:
- Ensuring that the BPCR’s are being reviewed in time.
4.0 ACCOUNTABILITY
Head- Quality Assurance
- PROCEDURE
- Executive, Quality Assurance shall review the process of dispensing, manufacturing, packing as per steps and procedure in the relevant BPCR.
- During the course of BMR review, Executive Quality Assurance shall ensure that each activity is correctly recorded in the relevant forms or designated space in BMR.
- The Executive, Quality Assurance shall review the process under the following heads but may not be limited to:
- Material Dispensing
- Check entries of starting materials with relevant store document
- Check entries in weighment sheet of BPCR.
- Check the correctness of potency calculation if applicable.
- Manufacturing operation
- Ensure and confirm that each manufacturing operation is correctly recorded.
- The time of operation and other entries are signed and dated by the person supervising the activity.
- In-process parameters like weight / fill variation, thickness, diameter, etc. shall be verified.
- Ensure the accuracy of packaging material used.
- Test reports
- Verify that the test results are in accordance with the current specifications of the product / material.
5.3.3.2 The test report is signed and authorized to proceed for next operation.
5.3.4 Miscellaneous checks
5.3.4.1 Confirm in-process checks are being performed as per respective SOPs and recorded with correct calculations.
- Correct yield is calculated and recorded in the BMR.
- Confirm reconciliation of packaging material is correct.
5.3.4.4 The certificate of analysis for finished product is attached.
- Assigning
of Expiry date to product.
- Review of any deviations.
- Confirm the retail price of the product if applicable.
- Ensure that there is no blank column or space.
- Ensure that no overwriting is allowed and correction is in accoring with SOP.
- Finally, after review of BMR by Executive Quality Assurance, the same shall be forwarded to Head, Quality Assurance for authorization of product release as per SOP.
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
Nil
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 |
