by 1.0 OBJECTIVE
To provide guideline for Issue, Receipt and Storage of Batch Manufacturing documents.
2.0 SCOPE
This SOP is applicable for Issue, receipt and storage of Batch Manufacturing documents of all products manufactured.
3.0 RESPONSIBILITY
3.1 QA personnel shall be responsible for:
3.1.1 Issue, receipt, storage and destruction of BPCR.
3.2 Head – QA shall be responsible for:
3.2.1 ensuring that procedure defined are adhered to during execution of same.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
5.1 Based upon the production plan, Head of production department or his designee send a requisition to QA department giving details of the product, batch number and number of batches for which BPCR & BPR (Batch Packing Record) are required.
5.2 Along with BPR issuance, details like sale packing, physician sample packing or export packing shall be mentioned in issuance details.
5.3 As per the requirement QA personnel shall arrange a zerox copy of the concerned master BPCR OR BPR. If the BPCR provided by the contract giver, for the products of contract manufacturing are adequate with respect to format, information and process control, than the copy of BPCR or BPR of contract manufacturer shall be used for recording purpose.
5.4 Production chemist shall assign a batch number as per the centralizes product batch number register which lies with the production department.
5.5 QA person shall affix his/her signature and write the date of issue on the first page of BPCR and BPR.
5.6 QA personnel shall put stamp in blue ink on the bottom side of each page of BPCR and BPR with sign of person.
5.7 The impression of stamp required for issuing BPCR and BPR shown.
5.8 The issue of the BPCR & BPR shall be recorded in the BPCR/BPR issue and retrieval register and the signatures of manufacturing & packaging person who is receiving same shall be taken in register as receipt of the same.
5.9 White A4 sheets to be used for making the master batch records & their issuance.
5.10 Additional page requisition
5.10.1 If in any case additional page of BPCR or BPR required for recording of process production personnel shall raise request, mentioning the reason for requirement (as described in annexure-III) of additional page and QA personnel shall issue the same on the basis of requisition and retain the requisition.
5.11 Retention and destruction of BPCR and BPR
5.11.1 Retention and destruction of BPCR as per the 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
| 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 |
