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WHO SOP List for Pharma Quality Assurance


List of Standard operating procedures for pharma QA as recommended by WHO.

Sr. No.
         Name of SOP
1.
SOP for Preparation, Approval, Distribution, Revision, Control and Retrieval of SOP
2.
SOP for Change Control
3.
SOP for Handling of market complaints
4.
SOP for Vendor Qualification
5.
SOP for Deviation Control
6.
SOP for Training of Employee
7.
SOP for Representation of Results on the Report & Abbreviations Used for Documentation
8.
SOP for Authorised Signatories
9.
SOP for Review of Batch Manufacturing Record
10.             
SOP for Process validation
11.             
SOP for Product Recall
12.             
Sop for Product Reprocessing & Reworking Policy
13.             
SOP for Documents of Results and Significant Figures
14.             
SOP for Mix up Prevention   
15.             
SOP for In-process Quality Control
16.             
SOP for Line Clearance of Equipments
17.             
SOP for Line Clearance for Overprinting Machine
18.             
Sop for Packing Line Clearance by Q.A.
19.             
SOP for Operation and Calibration for Balances
20.             
SOP for Oil and Moisture Content in Compressed air
21.             
SOP for Rodent/Pest/Insect control
22.             
SOP for general Housekeeping of Manufacturing Areas
23.             
SOP for Metal & Glass policy
24.             
SOP for Stability Studies of Pharmaceutical Product
25.             
SOP for Validation documentation
26.             
SOP for Job Description (Responsibilities and Authorities)
27.             
SOP for out of Expectation
28.             
SOP for Semi-finished storage
29.             
SOP for External laboratory audit
30.             
SOP for Toxic effects and Treatment of poison & hazardous chemicals
31.             
SOP for Control of approved specimen
32.             
SOP for Instrument which is out of Calibration
33.             
SOP for Analysis of reworking
34.             
SOP for Document numbering system
35.             
SOP for Documentation Control & Issuance
36.             
SOP for Preparation of 70 % V/V IPA Solution
37.             
SOP for Operation of Wet and Dry Bulb Thermometer
38.             
SOP for Waste disposal
39.             
SOP for Destruction of Rejects of Packing Material
40.             
SOP for the Destruction of Rejects of Raw Material, Bulk & Finished Product
41.             
SOP for General Principle in Production Area & Store Area.
42.             
SOP for Preparation of MFR,BMR & BPR                
43.             
SOP for Calibration of Timer               
44.             
SOP for APQR                
45.             
SOP for Calibration of Rapid Mixer Granulator (R.M.G.) for Rotations per Minute             
46.             
SOP for Calibration of Rotations per Minute of Peristaltic Pump         
47.             
SOP for Technology transfer
                
48.             
SOP for Calibration of Coating Pan for Rotations per Minute               
49.             
SOP for Calibration of Blender for Rotations per Minute          
50.             
SOP for Preparation of SMF             
51.             
SOP for  Cleaning Validation
52.             
SOP for the handling and investigation of non-conformance
53.             
SOP for Analytical method validation
54.             
SOP for Out of Specification for Chemical Testing.
55.             
SOP for Analyst / Personnel Validation
56.             
SOP for cleaning and replacement of Return riser filter.
57.             
SOP for preparation of VMP
58.             
SOP for self inspection
59.             
SOP for GMP Committee
60.             
SOP for Corrective and Preventive action
61.             
SOP for Out of specification results for microbial analysis
62.             
SOP for Incidence / Failure
63.             
SOP for SAP Password Security
64.             
SOP for Quality Risk Management
65.             
SOP for Labelling
66.             
Procedure for Online Rejection
67.             
Procedure for handling and reporting of Adverse Drug Reactiions
68.             
Procedure for In-process checks during Liquid oral manufacturing and packing.




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