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WHO SOP List for Pharma Quality Control


List of Standard operating procedures for Quality Control in pharmaceuticals.

Following is the list of WHO SOPs for Pharmaceutical Quality Control



Sr. No.
Title of  SOP
  1.   
PROCUREMENT & HANDLING OF REFERENCE STANDARD
2.   
HANDLING OF GLASSWARE
3.   
HANDLING OF SAMPLE OF  IN PROCESS, FP, & RM IN THE QC LABORATORY AFTER TESTING
4.   
CONTROL OF DOCUMENTS OF EXTERNAL ORIGIN
5.   
HANDLING OF HAZARDOUS CHEMICALS
6.   
MANUAL GLASSWARE CLEANING PROCEDURE
7.   
PREPARATION AND HANDLING OF WORKING STANDARDS
8.   
USE AND STORAGE OF REAGENTS AND CHEMICALS
9.   
PROCEDURE FOR ANNUAL MAINTENANCE CONTRACT FOR QC INSTRUMENTS
10. 
PREPARATION OF REAGENTS
11. 
PREPARATION OF VOLUMETRIC SOLUTIONS
12. 
SAMPLING PROCEDURE FOR RM
13. 
LABORATORY CLEANING
14. 
HAND WASH PROCEDURE
15. 
GOWNING PROCEDURE
16. 
SAMPLING PROCEDURE OF PACKAGING MATERIAL.
17. 
QUALIFICATION OF ANALYST
18. 
STORAGE CONDITION OF RM
19. 
HANDLING OF SPILLAGES IN THE LABORATORY.
20. 
ACTION LEVEL PROCEDURE
21. 
STATISTICAL STUDY FOR TREND ANALYSIS OF P.W.& W.F.I.
22. 
IDENTIFICATION OF ACTIVE RM
23. 
RETESTING SCHEDULE OF R.M.
24. 
ACCEPTANCE QUALITY LEVEL OF PACKAGING MATERIAL
25. 
USE OF LOG CARDS FOR INSTRUMENT STATUS
26. 
CONTROL OF MASTER DATA OF GENERATION
27. 
R.M. RELEASE PROCEDURE
28. 
RELEASE PROCEDURE FOR F.P.
29. 
DISPOSAL OF EXPIRED CHEMICALS, REAGENTS, SOLVENTS, AND MICROBIOLOGICAL MEDIUM
30. 
ARTWORK RECEIVING PROCEDURE
31. 
RELEASE PROCEDURE FOR P.M.
32. 
PROCEDURE TO CONTROL STATUS LABELS & TO MAINTAIN ITS STOCK
33. 
PROCEDURE FOR GENERAL TEST PROCEDURE
34. 
RETESTING SCHEDULE OF P.M.
35. 
MAINTENANCE OF DESICCATOR
36. 
HANDLING OF POISONOUS CHEMICALS
37. 
MAINTENANCE AND CLEANING OF SAMPLING  DEVICES
38. 
PREPRATION, APPORVAL AUTHARIZATION,RIVISION AND CODING OF STP
39. 
CALIBRATION OF INSTRUMENTSFROM OUTSIDE AGENCY
40.
PREPARATION OF P.M. SPECIFICATION AT TPL
41.
PROCEDURE FOR PREPARING M.O.A. OF R.M. AND F.P. OF API
42.
RELEASE PROCEDURE FOR INTERMEDIATES AND FP OF API
43.
INVESTIGATION OF OOS ANALYTICAL RESULTS(QA)
44.
CONTROL OF QUALITY MANUAL
45.
PROCEDURE FOR INTERNAL TRANSFER OF R.M.
46.
PREPARATION AND CONTROL OF DATA SHEET
47.
HANDLING AND CONTROL PROCEDURE FOR PROHIBITED ITEMS
48.
COLLECTION AND STORAGE OF RETAINED SAMPLES OF R.M.
49. 
COLLECTION AND STORAGE OF RETAINED SAMPLES OF P.M.
50. 
RECEIPT AND MAINTENANCE OF WORKING STANDARD OF
51.
PREPARATION AND HANDLING OF PRIMARY STANDARDS
52.
PROCEDURE FOR HANDLING AND TESTING OF IN PROCESS SAMPLES
53. 
ACCEPTANCE QUALITY LEVEL OF PACKAGING MATERIAL
54.
GOWNING AND DE-GOWNING PROCEDURE FOR VISITORS (i.e. AUDITORS, INSPECTORS etc.)
55.
HANDLING PROCEDURE FOR FP AND IN PROCESS SAMPLES FOR CONTRACT MANUFACTURING
56.
ROUNDING OFNUMERIC  FIGURES 
57. 
PROCEDURE FOR HANDLING AND TESTING OF VARIOUS SAMPLES RECEIVED AT Q.C. (MISCELLENAOUS, TRC, VALIDATIONS, AND STABILITY SAMPLES)
58.
PREPARATION AND CONTROL OF TEST DATA SHEET FOR PROCESS VALIDATION SAMPLES
59. 
PREPARATION AND CONTROL OF PROTOCOL FOR WORKING STANDARDS
60.
PROCEDURE FOR WASHING HPLC COLUMN AFTER USE
61. 
Cleaning and sanitization  of Microbiology Laboratory
62. 
Environmental monitoring of Microbiology Laboratory
63. 
Microbial monitoring of Product Processing area (Oral dosage form)
64. 
Sampling and testing of water
65. 
Media and reagent  preparation and storage
66. 
Maintenance and use of microbial pure culture
67. 
Sampling and testing of compressed air and nitrogen gas
68. 
Disposal of contaminated waste (Media / Culture ) of microbiology laboratory 
69. 
Environmental monitoring of sampling and dispensing area
70. 
Cleaning / Sterilization /Sanitization / Depyrogenation of accessories used in Microbiology Laboratory
71. 
Entry, Exit , work instruction and material transfer in clean area (Testing room) of Microbiology Laboratory
72. 
Identification of micro organisms
73. 
Microbial monitoring of Drainage of Processing area
74. 
Disinfectant approval procedure
75. 
Handling of spillage of media
76. 
Handling of Biological Indicator
77. 
Entry and  Exit  procedure of microbiology section
78. 
Growth promotion test for culture Media
79. 
Data Maintenance for routine contaminant     ( Environment and water  isolates)
80. 
Preparation of test solution 
81. 
Preparation of Disinfectant and Cleaning solution  
82.
SAMPLING PROCEDURE OF PACKAGING MATERIAL
83.
PROCEDURE TO VERIFY SHIPMENT OF PACKAGING MATERIAL
84.
BEHAVIOUR AT WORK PLACE
85.
MANNUAL GLASSWARE CLEANING
86.
HPLC COLUMN RECEIPT AND CHECKING
87.
PROCEDURE OF SIEVE ANALYSIS
88.
PROCEDURE FOR ALLOCATION OF INSTRUMENTS/EQUIPMENTS IDENTIFICATION NUMBER
89.
CALIBRATion procedure
90.
safety in quality control
91.
sampling procedure for packaging material
92.
procedure for entru/exit to stability area
93.
procedure for specification of analytical method transfer
94.
to lay down the procedure for discontinution of stability study of any product
95.
to describe the initiation of stability study and sample withdrawl for analysis
96.
recording and verification of enviornment condition of controlled enviornment chamber
97.
procedure for carriying out in house calibration of controlled enviornment  chamber
98.
records of maximum and minimum temperatire of refrigrator
99.
to lay dowmn the procedure for recording temperature of stability oven.
      100.
RELEASE PROCEDURE FOR RAW MATERIALS




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