Laboratory Investigation Checklist – OOS Result

Checklist / Check points of Laboratory preliminary Investigation (OOS Phase I) for find out the root cause for out of specification (OOS) test results.

Laboratory Investigation Check Points / Report

OOS Number : OOS login Date :
Name of Product :
Batch No. : Market :
Batch Size / Qty : Mfg. Date :
Test : G.R. No. / A.R. No. :
Name of Analyst : Date of the Analysis :



RM                  FP Exp. Date / Retesting Date :


Others (specify)
Release Stability
Raw Material/Packing Material/Finished Product/Stability/In process (Laboratory Investigation)
Sr. No. A.R. No. Batch No. Pack Code & Packing details Condition Observation
Details of OOS Result [Relevant code of product (Finished Product/RM/PM) shall be maintained]:
Related : SOP for Handling Out of Specification (OOS) Results
Whether the OOS is Re-occurrence (Yes/No) If Yes OOS No.: ____________
Name of Analyst/Initiator : Name of Reviewer  :
Sign / Date : Sign / Date :

Section A:

  • Laboratory Investigation (Phase 1a):-

Date of Laboratory Investigation :-
Method/ Analyst Verification Observation Yes No Suspected
1. Was analyst trained in the particular test / techniques?        
2. Was corrected standard test procedure used for the analysis? (Specify the number with current version)        
3. Was analytical method adequate and followed properly?        
4. Was evident from the discussion that the analyst has understood Analytical Method and the operation SOP of the equipment/ instrument used?        
5. Was there evidence that the system suitability requirements of the analytical method met?        
6. Had the analyst calculated that results correctly as mentioned in standard test procedure?        
7. Had the analyst calculated the results using correct potency of the working / reference standard?        
8. Was there any similar history with the product / material?        
9. Was any past incident done by the same analyst and what was the conclusion?        
10. Was any past incident happened in test parameters in same product and what was the final conclusion?        
11. Was stock solution of standard, system suitability, sample and or any other solution available?        

Laboratory Glassware Verification / Investigation

12. Were proper volumetric glassware used for analysis?        
13. Were correct volumetric pipettes / burettes used for analysis?        
14. Was there any obvious evidence of glassware contamination? (Visual)        
15. Was there any evidence or probability that the glass ware not washed or dried properly?        
16. Were the glassware used for analysis properly and legibly labeled?        

Analysis Process Verification (Laboratory Investigation)

17. Was there any evidence that the sample was not stored properly?        
18. Were the dilutions made in sample / standard preparation as per standard test procedure?        
19. Were the environmental conditions (temperature, Relative humidity, light) during analysis appropriate?        
20. Were there any instrument related problem noticed?        
21. Were the regents / chemicals used of recommended grade and prepared as per the standard test procedure?        
22. Were used volumetric solutions standardized as per procedure?        
23. Were the correct working / reference standard used for analysis? (specify the number with validity)        
24. Were the standards, reagents, used, properly stored?        
25. Was there evidence that the reagents, standards or other materials used for test were contaminated?        
Equipments / Instruments
26. Was the instrument used for analysis with in the calibration period? For example

HPLC, GC, UV, Dissolution etc.

(specify the ID number & next calibration due date)

27. Was Instrument Set-up according to standard test procedure?        
28. Was the possibility of any leakage or air bubble in the system?        
29. Was the correct system parameters used during analysis?        
30. Was the proper electrical and tubing connections given to the system?        
31. Was the correct volume of dissolution medium used for analysis?        
32. Dose any physical observation noted during dissolution testing?        
33. Was there any power failure during analysis?        

Chromatographic related parameters (Laboratory Investigation)

Mobile Phase
34. Was the pH of the Mobile Phase adjusted correctly as per standard test procedure? (specify if any)        
35. Was the mobile phase filtered by using proper filters specified in standard test procedure?        
36. Was the mobile phase degassed properly before usage?        
37. Was the corrected column used as specified in standard test procedure? (specify the column number)        
38. Was any leakage observed in column fittings?        
39. Was the column flushed properly before usage?        
40. Was the correctness of raw data peak shape, system suitability criteria, retention time matching?        

Heating Equipment (LOD Oven and muffle furnace)

41. Were the temperature indicators within calibration range? (specify the next calibration due date)        
42. Was the heating equipment malfunctioning observed during operation?        

Weighing Verification (Laboratory Investigation)

43. Balance I.D. No.:        
44. Was the balance used for weighing, within calibration date? (specify next calibration date)        
45. Were weights taken accurately, without spillage?        
46. Was the weighing as per standard test procedure?        
47. Was the malfunctioning of balance observed during weighing?        

Karl Fisher / Auto titrator

48. Was the instrument calibrated before use?

(specify the identification number & next calibration due date)

49. Was the corrected factor used for analysis?        

Stability Chambers

50. Was the instrument / equipment within calibrated period? (specify the ID number & next calibration due date)        
51. Was the temperature & humidity mapping within the specified acceptance criteria for the particular temperature and humidity condition?        
52. Was the temperature & humidity within the acceptance criteria?        
53. Was the breakdown/malfunctioning /excursion observed for the particular stability chambers?        

pH  Meter

54. Was the pH meter within the calibration period? (specify the calibration date)        
55. Was the standard buffer used for calibration within validity period?        

Related Substances Analysis (Laboratory Investigation)

56. Was system, purged before start of the analysis?        
57. Was blank solution (Diluent / mobile phase) injected to identify any unknown peaks?        
58. Was standard, system suitability, placebo and sample solution injected within the solution stability period?        
59. Was the peak of concern is an unknown impurity?        
60. Was the peak of concern is degradation product?        
61. Was peak  of concern found in blank / mobile phase / placebo?        

Laboratory Condition (Investigation)

62. Was the laboratory environment satisfactory during the testing of the samples?        

Details of the interview of the Analyst:

Name of Analyst:        ___________________________                                                                           

Name of Interviewer :_________________________

Analyst Sign/Date:                                                                                             Interviewer Sign/Date :

Summery / Conclusion of Laboratory Investigation:

Prepared By Sign / Date:                                                            QC Head Sign / Date:

Laboratory Hypothesis Analysis / Investigation (Phase 1b)

S.No. Repeat Analysis (Re-Analysis) Yes No Comments Annexure
1. Re-injection from the same vial (original preparation) for verification to identify injection error or programming error
2. Re-filtration from the same final dilution of the sample to verify the usage of inappropriate filter paper, insufficiently saturated filter or contaminated vials, septum’s / filters.
3. Re-dilution from the stock solution to investigate if the incident is due to dilution error. If yes, then the same stock solution shall be re-diluted, wherever applicable and analyzed.
4. Re-sonication / Re-shaking due to incomplete solubilization of the analyze in the test preparation due to inadequate shaking and / or sonication or improper grinding of the test sample, wherever applicable.
5. Any other (if)
Summery of Laboratory investigation from hypothesis:

Prepared by Sign / Date:                                            Reviewed By Sign/Date:

 Conclusion with justification:

Recommended Corrective & Preventive Action (From Phase Ia and Ib):
QA Comments
Section B: Phase-IIa Investigate checklist related to manufacturing process
OOS number:-
Sr. No. Check Points Observations Remarks
1. Is the right and approved procedure used in processing?    
2. Whether approved BMR is used? (Mention MFR and BMR number)
3. Whether all steps of processing followed properly as per BMR?
4. Whether the process is validated?
5. Whether each process steps is checked by the concerned department supervisor?
6. Whether yield reconciliation carried out and yield is within the limits as per BMR/BPR?
7. Whether change control or deviation is proposed for this batch? (Mention Change control or Deviation number)


1. Is the operator adequately trained and followed BMR/BPR?
2. Whether the SOPs followed properly?
3. Whether the hygienic practices followed?
1. Whether right equipments used as per BPR and details recorded in equipment logbook?
2. Whether all equipment used in the process have been qualified?
3. Whether the manufacturing equipments operated as per SOP?
4. Whether critical gauges and manufacturing devices are calibrated and used within calibration due date?
5. Whether all the equipments are cleaned before use?
6. Whether preventive maintenance carried out for all equipments used in processing?
1. Whether the right materials dispensed for the batch?
2. Whether API and excipients used for the batch are approved?
3. Whether exact quantity of the material is dispensed as per BPR?
4. Whether the right material used during processing?
5. Were there any changes of contamination?
1. Whether area cleaning and sanitation carried out as per SOP?
2. Whether environmental conditions are monitored and recorded as per BPR?
1. Product contamination (give details)
2. Any other observation made by the operator during operation


1. Whether correct material / product are sampled?
2. Whether appropriate SOP followed for sampling?
3. Whether sample was properly stored and handled?
4. Whether correct sampling tools are used?
5. Whether sampling personnel trained as per SOP?
6. Whether sampling personnel understood the procedure?
7. Whether hygiene practices are followed throughout sampling?
8. Whether any other contamination sources observed?
9. Error in sampling:

Handling Error:

Error in storage of sample:

10. Any abnormal observation(s) in environmental monitoring records
11. Error in labeling details in the container to be sampled & product name, manufacturing details, etc.


12. Whether re-sampling performed only when original sample is proved an unrepresentative?
13. Whether re-sampling performed only when original sample quantity was not sufficient?
14. Whether re-sampling performed as per method used for initial sample?
15. Whether new-sampling method is developed only when initial sampling method found faulty (error)?
Phase – IIa Investigation Details:



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