1. OBJECTIVE
To lay down the procedure for sampling and release of inprocess liquid Oral samples
2. SCOPE
This procedure is applicable to Quality assurance and Quality Control Department
3. RESPONSIBILITY
• Officer QC
• Officer QA
• Manager QC and QA
4. SAFETY INSTRUCTIONS
• N/A
5. PROCEDURE
5.1 SAMPLING
5.1.1 Bulk sample after completion of particular manufacturing step, the production department shall intimate quality assurance department through the bulk sample intimation slip and test request form.
5.1.2 Quality assurance personnel shall sample from the bulk storage tank after receiving the intimation and shall fill up all the batch details in the test request form and send it quality control department.
5.1.3 Quality assurance personnel shall sample from top and bottom and composite quantity shall be as per product requirement.
5.1.4 Quality assurance personnel shall also sample the validation batches and the sampling pattern shall be as per the individual protocol
5.2 Release
5.2.1 The quality control department shall analyze the sample for the respective activities and then handover a GREEN color release tag to the quality assurance personnel, who in turn paste it in the batch manufacturing record
6. RELATED DOCUMENTS
Analysis request forms – Annex-I
Sampling and release tags – Annex-II
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
| Production Department | 01 | , |
8. ABBREVIATIONS
N/A
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 10/08/2022 | 00 N/A | First Version |