Checklist for OOS Investigation

A. Investigation in Laboratory

1. Analyst errors

Analysts must investigate for laboratory errors which can occur when analysts make analytical mistakes. Check if samples were incorrectly prepared, diluted, injected or stored at an inappropriate environmental temperature or that containers not properly closed or possibly not sampled in the correct designated sampling containers and the following points.
1.1 Weighing errors (sample weight & measurement)
1.2 Calculation errors (also completeness of raw data)
1.3 Errors associated with dilutions, mobile phase, filters, chromatographic, condition etc. that are required by the corresponding analytical procedure

1.4 Review of critical steps followed during analysis
1.5 Whether reference/ working standard used in the analysis are correct (in term of appearance, expiry date potency, LOD / water and its storage) and assay values are determined correctly
1.6 Whether properly prepared test solution(s) or volumetric
1.7 Any loss of standard solution or test solution during preparation
1.8 Any other techniques in analytical procedures were not appropriately applied during testing
1.9 Any unusual or unexpected response observed with standard or test preparations (e.g. Whether contamination of equipment by the previous sample observed)
1.10 Whether the analysis is performed by any other alternate validated procedure
1.11 Whether analyst is trained to perform the test
1.12 Whether the environment condition is suitable to perform the test
1.13 Cleaning of glassware and calibration status
1.14. Analyst validation

2. Instrument/ Equipment Errors

2.1 Any malfunctioning and/ or out of calibration analytical instrument/ equipment (including glassware) were used in the analysis.
2.2 Review RSD, resolution factor and l or other parameters required for the suitability of the test system. check, if any out-of-limit parameter is included in the chromatographic analysis.
2.3 Correctness of the column used
2.4 Previous column used
2.5 Calibration status of instrument/ equipment
2.6 Preventative maintenance

3. Laboratory System Errors

3.1 Discuss the test method with the analyst; confirm analyst knowledge of the correct procedure.
3.2 Analyst should be trained on the instrument/ equipment and record maintain
3.3 Calibration schedule
3.4 Shelf-life of solutions
3.5 Test method and calibration procedure
3.6 Working standard qualification
3.7 Column efficiency
3.8 Environment conditions

B. Investigation in Manufacturing

1. Operator Error

1.1 Operator trained on equipment:
1.2 Any operator error (wrong weight addition, wrong material addition, wrong sequence of addition)?
1.3 Interview with operator:

2. Equipment Error

2.1 Whether specified and validated equipment is used?
2.2 Whether any malfunctioning of equipment noticed?
2.3 Whether any power failure for extended period during manufacturing?

3. Production Control System Error

3.1 Whether standard Master Formula is adhered to?
3.2 Whether process is validated?
3.3 Whether standard manufacturing procedure is adhered and correct entries made in batch production record?
3.4 Whether correct sampling procedure is used?
3.5 Any deviation from cGMP/ SOP? (give details)
3.6 Whether any change in blending time/ drying time etc.?
3.7 Whether any spillage of material noticed during processing?
3.8 Whether environmental conditions, specified are followed?
3.9 Whether the product is held within validated time at all stage of manufacturing?
3.10 Whether storage containers are suitably stored at the designated place, at different stages of manufacturing. Give details of the storage time at different stages.
3.11 Check reconciliation of yield at various stages. If exceeded above standard, then state the reason thereof.
3.12 Whether yield of previous and next batch is within limit of acceptance criteria?
3.13 A summary of the aspects of the manufacturing process that may have caused the problem.
3.14 Other observations (if any)
3.15 Process Documentation Review:

D. Warehouse related investigation

1. Whether used material purchased from approved vendor?
2. Whether storage condition of RM/PM store maintained?
3. Whether dispensing operators trained?
4. Whether correct material used as given in bill of material?
5. Whether physical stock of used material is matches with written quantity?
6. Whether proper line-clearance procedure followed in dispensing of previous and next batch?
7. Whether dispensed material hold within the validated time before the start of manufacturing?

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