*Comprehensive Internal Audit Plan – 20 Observations per Department*
*Company:* [Your Company Name]
*Audit Scope:* Liquid Injection, Quality Assurance (QA), Quality Control (QC), Warehouse, Production (Tablets, Capsules,
Cream)
*Audit Type:* Internal Audit (GMP Compliance)
*Audit Duration:* [Start Date] to [End Date]
## *1. Liquid Injection (20 Minor Observations)*
1. *Incomplete BMR entries* – Missing signatures in batch manufacturing records.
2. *Line clearance not documented* – No evidence of cleaning before new batch initiation.
3. *Environmental monitoring gaps* – No trend analysis for particle counts in aseptic areas.
4. *Vial inspection sampling insufficient* – Only 1% checked instead of recommended 2%.
5. *Leak test records incomplete* – Some vials missing leak test documentation.
6. *Filter integrity test logs missing* – No records for pre- and post-filtration checks.
7. *Minor deviations not closed on time* – Delays in investigation reports.
8. *Expired reagents in lab* – Some solutions found beyond expiry date.
9. *Calibration overdue for pH meter* – Not recalibrated as per schedule.
10. *Personnel gowning lapses* – Improper sanitization of gloves observed.
11. *No preventive maintenance records* – For autoclave and filling machine.
12. *Temperature excursions in storage* – No corrective action documented.
13. *Incorrect labeling of quarantine stock* – Some vials not marked properly.
14. *Lack of training records* – New operators not trained on revised SOPs.
15. *No backup for critical data* – Electronic records not archived properly.
16. *Minor spills not logged* – Small leaks during filling not recorded.
17. *Glass breakage procedure not followed* –
18. *Pressure differential fluctuations* – Not investigated in filling area.
19. *Missing logbook entries* – For equipment usage.
20. *No risk assessment for manual interventions* – During aseptic processing.
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## *2. Quality Assurance (20 Minor Observations)*
1. *Delayed change control closures* – Minor changes pending for >30 days.
2. *Incomplete training records* – Some employees missing annual GMP refreshers.
3. *Minor deviations not trended* – No periodic review for recurring issues.
4. *SOPs not reviewed annually* – Some documents past revision date.
5. *No backup for electronic QA records* – Audit trail not maintained.
6. *Customer complaints not analyzed* – No trend report for last 6 months.
7. *Stability study delays* – Interim test points missed.
8. *Validation protocols outdated* – Not updated per current guidelines.
9. *Supplier qualification overdue* – Some vendors not re-evaluated.
10. *No mock recall exercise* – Last test conducted >12 months ago.
11. *Inadequate CAPA effectiveness checks* – Some actions not verified.
12. *Document control lapses* – Uncontrolled copies found in production.
13. *Risk assessments not updated* – After minor process changes.
14. *No training on new regulatory guidelines* – Recent updates not covered.
15. *Incorrect document version in use* – Old SOP found at workstation.
16. *Missing batch review signatures* – QA head not signing some records.
17. *No periodic review of environmental data* – Trends not analyzed.
18. *Inadequate investigation root cause analysis* – Some deviations poorly assessed.
19. *Calibration schedule not followed* – QA instruments overdue.
20. *No backup for quality agreements* – Some contracts not archived digitally.
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## *3. Quality Control (20 Minor Observations)*
1. *Calibration overdue for balances* – Some not done as per schedule.
2. *Expired reference standards in use* – Not removed from lab.
3. *Incomplete raw data entries* – Missing initials in logbooks.
4. *No system suitability checks* – For some HPLC runs.
5. *Stability samples not pulled on time* – Delays in testing schedule.
6. *Reagent labeling incomplete* – Concentration/date missing.
7. *Glassware not properly cleaned* – Residues observed in some flasks.
8. *No temperature mapping for storage* – Some fridges not monitored.
9. *Out-of-specification (OOS) delays* – Some investigations pending.
10. *No backup for chromatographic data* – Electronic records at risk.
11. *Incorrect waste segregation* – Chemical waste mixed with general waste.
12. *Training gaps for new analysts* – Not trained on updated methods.
13. *Sample retention issues* – Some finished products missing retention samples.
14. *No preventive maintenance for lab equipment* – HPLC/GC maintenance delayed.
15. *Incorrect sample storage* – Some samples kept beyond recommended time.
16. *Missing logbook entries* – For instrument usage.
17. *No trend analysis for lab incidents* – Recurring errors not reviewed.
18. *Inadequate sample homogenization* – Some powder samples not mixed properly.
19. *No verification of third-party lab data* – External test results not cross-checked.
20. *Lack of data integrity controls* – No audit trail for manual integrations.
---
## *4. Warehouse (20 Minor Observations)*
1. *Temperature excursions not reported* – In cold storage areas.
2. *FIFO not followed* – Some raw materials stored incorrectly.
3. *Expired materials not segregated* – Found in active storage.
4. *Incorrect labeling of quarantine stock* – Missing status labels.
5. *Pest control gaps* – No recent service records.
6. *Inadequate stock reconciliation* – Minor discrepancies in raw materials.
7. *No humidity control logs* – For hygroscopic materials.
8. *Damaged packaging not reported* – Some cartons torn but still in use.
9. *Unauthorized access to storage areas* – Logbook missing entries.
10. *No backup power for cold storage* – Risk of temperature deviations.
11. *Incorrect storage of flammable materials* – Not in designated area.
12. *Missing MSDS for some chemicals* – Safety data sheets not updated.
13. *No periodic stock verification* – Some items not checked for months.
14. *Inadequate cleaning records* – For warehouse floors and shelves.
15. *No training for forklift operators* – Some untrained personnel handling goods.
16. *No segregation of rejected materials* – Found near approved stock.
17. *Incorrect barcode scanning* – Some materials not scanned in system.
18. *No alarm testing for cold rooms* – Last test >6 months ago.
19. *Inadequate fire safety checks* – Extinguishers not inspected monthly.
20. *No disaster recovery plan* – For warehouse data backup.
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## *5. Production (Tablets, Capsules, Cream) (20 Minor Observations)*
1. *Incomplete BMR entries* – Missing operator signatures.
2. *Line clearance not verified* – Residues from previous batch seen.
3. *In-process checks skipped* – Some weight checks not recorded.
4. *Equipment calibration overdue* – Tablet compression machine not calibrated.
5. *No yield reconciliation* – Unexplained losses in some batches.
6. *Improper gowning practices* – Operators not wearing masks properly.
7. *Cleaning validation gaps* – Swab test records incomplete.
8. *No preventive maintenance logs* – For capsule filling machine.
9. *Minor spills not cleaned immediately* – Powder residues on floor.
10. *Incorrect labeling of intermediate products* – Missing batch details.
11. *No training records for new hires* – Working without proper induction.
12. *Temperature deviations in drying oven* – Not investigated.
13. *No backup for electronic batch records* – Risk of data loss.
14. *Inadequate change control for minor process changes* – Not documented.
15. *Expired raw materials used* – Some excipients beyond retest date.
16. *No leak test for cream tubes* – Some defects observed.
17. *Incorrect disposal of rejected tablets* – Not destroyed properly.
18. *No trend analysis for production deviations* – Recurring issues not reviewed.
19. *Inadequate pest control in production area* – Insects seen near storage.
20. *No alarm testing for HVAC system* – Last test >6 months ago.
---
### *Next Steps:*
- *CAPA Plan:* Assign corrective actions with deadlines.
- *Training:* Conduct refresher sessions on GMP compliance.
- *Follow-up Audit:* Verify effectiveness in 3 months.
Would you like any modifications or additional details for specific areas? *Internal Audit Observations – Liquid Injection
(Ampoules) – 20 Minor Findings*
### *1. Documentation & Records*
1. *Incomplete batch records* – Missing signatures for critical steps in ampoule filling.
2. *No line clearance documentation* – Before starting a new batch, no signed checklist.
3. *Environmental monitoring records incomplete* – Missing entries for viable particle counts.
4. *Leak test records not maintained* – Some ampoules not tested for seal integrity.
5. *No trend analysis for sterility failures* – Minor incidents not reviewed periodically.
### *2. Equipment & Calibration*
6. *Ampoule sealing machine overdue for calibration* – Last calibration expired.
7. *No preventive maintenance records* – For ampoule washing and filling machines.
8. *Temperature mapping not done* – For ampoule annealing tunnel.
9. *Pressure differential logs incomplete* – Between filling and sealing areas.
10. *Filter integrity test records missing* – For sterilizing-grade filters.
### *3. GMP & Aseptic Practices*
11. *Improper gowning in aseptic area* – Operators not sanitizing gloves properly.
12. *Minor breaches in aseptic technique* – Hand movements near open ampoules.
13. *No media fill simulation for 12 months* – Last trial not recent.
14. *Glass breakage not logged* – During ampoule handling.
15. *No risk assessment for manual interventions* – During filling stoppages.
### *4. Storage & Handling*
16. *Ampoule storage temperature excursions* – No corrective action recorded.
17. *Quarantine ampoules not labeled properly* – Missing "HOLD" status.
18. *No FIFO for empty ampoules* – Older stock used after new arrivals.
19. *Damaged ampoules not segregated* – Found in good stock.
20. *No backup power for ampoule storage fridge* – Risk of temperature deviation.
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### *Additional Recommendations for Ampoule Section:*
- *Immediate CAPA:* Calibration of sealing machine, media fill simulation.
- *Training:* Aseptic practices, documentation, and leak testing.
- *Periodic Review:* Environmental monitoring trends, sterility data.
Would you like any further refinements or additional areas for ampoule observations?
