by 1.0 OBJECTIVE
To provide guidelines for release of finished products for sale and distribution.
2.0 SCOPE
2.1 This SOP is applicable for release of finished products manufactured.
3.0 RESPONSIBILITY
3.1 Quality Assurance (QA) personnel shall be responsible for:
3.1.1 Reviewing filled batch production and control record, batch packing record and withdrawal of Control sample of finished goods.
3.2 Head – QA shall be responsible for:
3.2.1 Release of finished goods for sale and distribution.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE:
5.1 After completion of final packing, packing supervisor raise intimation of Finished Goods (FG) Store Room / Bonded Store Room (BSR) Transfer slip of concerned product as described to QA Department or in the provision for transfer slip in the batch manufacturing document.
5.2 QA personnel verify the physical stock described in BSR transfer slip and attach with Batch Packing Record (BPR).
5.3 QA shall handover the reviewed batch manufacturing document of a particular batch along with the respective analytical reports to Head-QA.
5.4 Head QA shall ensure that control sample of particular batch has been collected.
5.5 Head QA shall ensure that the deviations if any, for the particular batch has been approved before release of the batch.
5.6 Head QA will intimate the Distribution-In-charge in writing to release the batch for sale and Dispatch as described in duplicate and same has to be attached with BPCR.
5.7 In absence of the head QA, the immediate designated deputy and so on will take over the Responsibility of the batch release.
5.8 In case of any specific requirement by a particular contract giver, their requirement shall be fulfilled.
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 |
