Sr. No. |
TITLE |
1 |
Preparation, approval, distribution, revision, control and retrieval of SOP |
2 |
Preparation of Master Formula Record (MFR), Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) |
3 |
Issuance and retrieval of BMR and BPR |
4 |
Document Numbering System |
5 |
Document & Data Control |
6 |
Preparation, review, approval and control of Standard Testing Procedure |
7 |
Preparation, review, approval and control of Analytical Work Sheets |
8 |
Review of BMR and BPR |
9 |
Good Documentation Practices |
10 |
APQR |
11 |
Specimen signature |
12 |
Preparation, Approval and Execution of Validation Protocols and Reports |
13 |
VMP preparation, approval & review |
14 |
Change Control Management |
15 |
Deviation Management |
16 |
OOS (Out of Specification) |
17 |
OOT (Out of Trending) |
18 |
RCA (Root Cause Analysis) |
19 |
FMEA (Failure mode & Effective Analysis) |
20 |
CAPA |
21 |
Handling and Investigations of non-conformances |
22 |
Self Inspection |
23 |
In-process for all dosage forms |
24 |
Line Clearance |
25 |
Status Labeling |
26 |
Final Inspection & Release of Finished goods |
27 |
Receiving of new equipment in facility and coding |
28 |
Vendor Qualification |
29 |
Product Recall |
30 |
Market complaints |
31 |
Control of Pricelist |
32 |
Reprocessing & Reworking |
33 |
Technology Transfer |
34 |
Prevention of mix-up and cross contamination |
35 |
Destruction policy |
36 |
Training of personnel |
37 |
Handling of returned goods |
38 |
Incident Reporting |
39 |
Disinfectant Usage Policy |
40 |
Checking of Overprinting material |
41 |
Environmental Monitoring |