by 1.0 OBJECTIVE
To describe the procedure of Line Clearance given by In Process Quality Assurance (IPQA) personnel.
2.0 SCOPE
This SOP is applicable for the procedure of Line Clearance given by IPQA personnel at various stages like Dispensing, Gelatin Manufacturing, Medicament preparation, Encapsulation, Inspection and Packaging areas.
3.0 RESPONSIBILITY
3.1 IPQA personnel shall be responsible for:
3.1.1 Giving Line Clearance.
3.2 Head – Quality Assurance shall be responsible for:
3.2.1 Ensuring that the procedures defined are adhered to during the execution of the line clearance.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDURE
5.1 Before commencing any activity, concerned supervisor shall obtain line clearance from IPQA personnel and get approval of area as stipulated in Batch Production and Control Record (BPCR).
5.1.1 In the event of any deviation from line clearance checks, the IPQA personnel shall bring it to the notice of concerned Supervisor and get it rectified.
5.1.2 Each concerned annexure shall be attached with the relevant BPCR.
5.2 Perform line clearance checks for gelatin store dispensing as described in annexure.
5.3 Perform Line clearance checks for and medicament dispensing as described in annexure.
5.4 Perform Line clearance checks for gelatin mass manufacturing as described in annexure.
5.5 Perform Line clearance checks for medicament preparation as described in annexure.
5.6 Perform line clearance checks for Encapsulation as described in annexure.
5.7 Perform line clearance checks for inspection area as described in annexure.
5.8 Perform line clearance checks for packing area as described in annexure.
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 |
