List of QA (Quality Assurance) SOPs

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
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)
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
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Jasleen Kaur a post graduate M. Pharm (Q.A.) is a senior pharma writer. She is responsible for authoring, reviewing and editing a range of pharmaceutical documents, including SOP, Validation, Qualification etc.