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Self Audit Checklist for Quality Control Department


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Sr. No.

Check points

Observation

Recommendation

Action

taken by

01

Is the control copy of QC department SOP’s available?

02

Are the personnel having knowledge of current GMP requirements?

03

Is the housekeeping maintained?

04

Is the weighting balance having proper tag of calibration status?

05

Is the balance calibration record available?

06

Are the calibrated standard weights available?

07

Is the calibration certificates available?

08

Is the standard weights are properly stored?

09

Are the status labels   available on each instrument?

10

Is the instrument calibration record available?

11

Check the temperature and humidity record.

12

Check the cleaning record.

13

Check the cleaning of sampling devices.

14

Are all the sampling devices properly stored?

15

Check the general cleaning and housekeeping of QC.

16

Are the specifications available for raw material, packing material, in-process samples, intermediates and finished products?

17

Check the in-process testing record.

18

Check the raw material testing record.

19

Check the final product testing record.

20

Check the stability record.

21

Check the stability chamber record.

22

Check the solution preparation and standardize record.

23

Check the control sample record.

24

Check all instrument log book.

25

Check the primary standards and its storage.

26

Check the mobile phase status of GC and HPLC.

27

Check the HPLC column record.

28

Check the test request slip record.

29

Check the personnel hygiene.

30

Check the safety equipments.

31

Check the other records.

32

Check the environment where control sample store?.

33

Is log book of destruction of control sample is maintained?

34

Is the out of calibrated instrument well labeled?

35

Is QC Chemist validated?

36

Is the sample in QC lab well labeled?

37

Are the personnel following GLP?

38

Are training given to   new personnel?

39

Are all QC personnel in proper dress code?

40

Is glassware breakage log book maintained?

41

Check DM water analysis record.

42

Check reference standard records?

43

Is proper sampling plan available?



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