Audit Checklist (s) for different department/section/area like – Engineering / maintenance, HVAC Area, Purified water system, Quality Control, Warehouse, Granulation, Compression, Coating, Packing / Packaging, Personal and administration (HR), Microbiology and Quality Assurance area etc. to check the effectiveness of the implemented systems.
Checklist for Routine Inspection /Audit
1.0 Audit checklist for Engineering area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment |
| Engineering Area Audit Checklist: | |||
| 1 | Ensure that engineering area are cleaned properly. | ||
| 2 | Communal tools are stored in designated areas. | ||
| 3 | Ensure that manuals are stored properly. | ||
| 4 | Ensure that drain points are not choked & they are cleaned properly. | ||
| 5 | Danger tags are available for use. | ||
| 6 | Preventive maintenance shall be carried out as per schedule. | ||
| 7 | Calibration of instrument shall be done as per schedule. | ||
| 8 | Safety clothing/equipment are used correctly for appropriate tasks. | ||
| 9 | Floors are clear of equipment or clear of waste. | ||
| 10 | SOP index is available. | ||
| 11 | Ensure that training record of personnel are available: (Check at least one person) Name:________________ E.Code:_______________ |
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2.0 Annexure-II : Audit checklist for HVAC area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment |
| HVAC Area – Audit Checklist: | |||
| 1 | Ensure that area around the AHU is clean. | ||
| 2 | Ensure that SOP for operation of HVAC system is available in the area. | ||
| 3 | Ensure that AHU operation log is updated. | ||
| 4 | Ensure that limit of DP across various filters of AHU is displayed and it should be with in specified limit. | ||
| 5 | Ensure that filter cleaning and monitoring record is available and maintained. | ||
| 6 | Ensure that PM of AHUs is done as per the schedule. | ||
| 7 | Validation of HVAC system is carried out as per specified frequency and its reports; certificates and validation documents are maintained. | ||
| 8 | Ensure that daily monitoring record of environmental monitoring in production area and other critical areas should be maintained. | ||
| 9 | Filter cleaning and monitoring record of dust collector should be maintained and updated. | ||
| 10 | Ensure that all the pipe lines are color coded. | ||
| 11 | Ensure that chiller operation log is updated. | ||
| 12 | Ensure that cooling tower cleaning record is updated. | ||
| 13 | Ensure that cooling tower cleaning schedule is available. | ||
| 14 | Ensure that training record of personnel are available:(Check at least one person)
Name:________________ E.Code:_______________ |
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3.0 Audit checklist for Water system area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment |
| Water System: | |||
| 1 | Ensure that water system area is clean & dry. | ||
| 2 | Ensure that SOP of operation of water system is available. | ||
| 3 | Ensure that RO water storage tank cleaning record is updated. | ||
| 4 | Ensure that drain points are not choked and cleaned properly. | ||
| 5 | Ensure that purified water storage tank temperature record is updated. | ||
| 6 | Ensure that sanitization record is updated. | ||
| 7 | Ensure that purified water tank vent filter record is updated. | ||
| 8 | Ensure that soft water plant regeneration data sheet is updated. | ||
| 9 | Ensure that distribution loop lines of Purified water systems are integrated as per approved drawing and is the system leak free, rust free & well maintained. | ||
| 10 | Ensure that regeneration record log sheet is updated. | ||
| 11 | Ensure that calibration and preventive maintenance record is available. | ||
| 12 | Ensure that raw water storage tank cleaning record is updated. | ||
| 13 | Ensure that RO membrane cleaning log sheet is updated. | ||
| 14 | Ensure that sand bed filter backwash record is updated. | ||
| 15 | Ensure that chemical consumption record is updated | ||
| 16 | Ensure that RO plant log sheet is updated. | ||
| 17 | Ensure that purified water temperature record during sanitization is updated. | ||
| 18 | Ensure that passivation record is updated. | ||
| 19 | Ensure that UV replacement record is updated. | ||
Related : SOP for Self Inspection /Internal Audit
| 20 | Ensure that RO plant filter replacement record is updated. | ||
| 21 | Ensure that soft water plant operation data sheet is updated. | ||
| 22 | Ensure that purified water loop operation record is updated. | ||
| 23 | Ensure that purified water temperature record is updated. | ||
| 24 | Ensure that RO membrane cleaning record is updated. | ||
| 25 | Ensure that SOP index is available. | ||
| 26 | Check whether seasonal trend of microbiology and chemical analysis data is available or not. | ||
| 27 | Ensure that all sampling point should be covered. | ||
| 28 | Check for dead legs. | ||
| 29 | Ensure that training record of personnel are available:(Check at least one person)
Name:________________ E.Code:_______________ |
4.0 Audit checklist for Quality Control (QC) Area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment |
| QC Area – Audit Checklist: | |||
| 1 | Ensure that area waste bins are not overflowing. | ||
| 2 | Ensure that all cupboards are cleaned. | ||
| 3 | Ensure that no unwanted items are inside the cupboard. | ||
| 4 | Ensure that calibration label is affix on each instrument/ equipments. | ||
| 5 | Ensure that the all instrument/ equipments are calibrated. | ||
| 6 | Ensure that all instrument/equipments log books are kept in the place. | ||
| 7 | Ensure that instrument/equipments are cleaned. | ||
| 8 | Ensure that the all volumetric solutions are properly labeled & within its validity. | ||
| 9 | Ensure that the all reagents & solutions are properly labeled & within its validity. | ||
| 10 | Ensure that all chemicals (Solid & liquid) are properly labeled & within its validity. | ||
| 11 | Ensure that temperature & humidity record are maintained of the lab and is within the specified limit. | ||
| 12 | Ensure that chemical store room are clean properly. | ||
| 13 | Ensure that all log books & documents are properly labeled. | ||
| 14 | Ensure that calibration records for all instrument/equipments are available and reviewed | ||
| 15 | Ensure that all log books are checked on daily basis. | ||
| 16 | Ensure that chemicals are store properly in chemical store room | ||
| 17 | Ensure that eye washer is working properly. | ||
| 18 | Ensure that environmental monitoring record of chemical storage room is updated. | ||
Environmental, Health and Safety – Audit Checklist: |
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| 1 | Ensure that all PPE are available for handling of all type of chemicals or which should be use during the routine analysis | ||
| 2 | Ensure that all MSDS related to chemicals/materials are available. | ||
| 3 | Ensure that all fire extinguisher are under validity. | ||
| 4 | Ensure that fire extinguisher are visible and accessible. | ||
| 5 | Waste bottle are not overflowing. | ||
| 6 | Fume hood cabinets are clear of unnecessary items. | ||
| 7 | Ensure that all employees must be trained in departmental SOPs, GMP and Safety related procedure. | ||
SOPs and Documentation – Audit Checklist: |
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| 1 | Ensure that SOP Files are accessible and filed properly. | ||
| 2 | Ensure that superseded versions have been returned to QA. | ||
| 3 | Ensure that all instrument Calibration label are in-place. | ||
| 4 | Ensure that all log book entries are properly filled and updated. | ||
| 5 | Ensure that control sample area monitoring record is available and updated. | ||
| 6 | Ensure that QC analytical protocol are filled properly. | ||
| 7 | Ensure that training record of personnel are available:(Check at least one person) Name:________________ E. Code:_______________ |
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| Glassware Washing Area: | |||
| 1 | Ensure that washing room is cleaned | ||
| 2 | Ensure that all glassware is kept in designated place. | ||
| 3 | Ensure that all the pendants are properly cleaned and marked. | ||
5.0 Audit checklist for Warehouse area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment |
| Receiving Bay & Dedusting Area – Audit Checklist: | |||
| 1 | Is the receiving bay is cleaned. | ||
| 2 | Ensure that air curtain is cleaned & limit switch is available for air curtain. | ||
| 3 | Ensure that approved vendor list is available. | ||
| 4 | Ensure that material are received as per approved vendor list. | ||
| 5 | Ensure that de-dusting area is cleaned. | ||
| 6 | Ensure that vacuum cleaner is cleaned & record is available. | ||
| 7 | Ensure that fly catcher is cleaned. | ||
| 8 | Ensure that pallets are cleaned. | ||
| 9 | Ensure that waste win is cleaned. | ||
| 10 | Ensure that ware house cleaning record is updated. | ||
| 11 | Ensure that balance is cleaned & calibrated. | ||
| 12 | Ensure that written procedure for receipt and storage of material is available. | ||
Quarantine – Audit Checklist |
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| 1 | Ensure that quarantine label are attached on the material. | ||
| 2 | Ensure that pallets are cleaned. | ||
| 3 | Ensure that quarantine area is cleaned. | ||
| 4 | Ensure that material, bag or box components shall be stored (over the pallet) off the floor. | ||
| 6 | Ensure that material are kept with proper segregation material wise and batch wise in quarantine area. | ||
RM Material Sampling Room – Audit Checklist: |
|||
| 1 | Ensure that sampling area are cleaned. | ||
| 2 | Ensure that pressure differential of area are maintained. | ||
| 3 | Ensure that balance are clean and calibrated. | ||
| 4 | Ensure that environmental condition i.e. temperature & RH are within limit and record is available. | ||
| 5 | Ensure that RLAF is cleaned. | ||
| 6 | Ensure that RLAF filter cleaning log book is updated. | ||
| 7 | Ensure that cleaning record of sampling area is updated. | ||
| 8 | Ensure that vacuum cleaner is cleaned & record is available. | ||
| 9 | Ensure that raw material sampling and cleaning log book is updated. | ||
| 10 | Ensure that any written procedure is available for sampling of raw material. | ||
| 11 | Ensure that sampling accessories are cleaned & labeled. | ||
| 12 | Ensure that riser is clean. | ||
| 13 | Ensure that door, window, glass and light are cleaned. | ||
| 14 | Ensure that daily calibration of balance record is updated. | ||
| 15 | Ensure that pressure differential of HEPA filter are with in limit. | ||
| 16 | Ensure that cleaning solution preparation log sheet is updated. | ||
Approved Area – Audit Checklist: |
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| 1 | Ensure that pallets and rack are properly cleaned. | ||
| 2 | Ensure that temperature & RH are within the limit, and record are maintained. | ||
| 3 | Ensure that ware house cleaning record is updated. | ||
| 4 | Ensure that material keeping with proper segregation material wise and batch wise in approved area. | ||
| 5 | Ensure that material, bag or box components shall be stored (over the pallet) off the floor. | ||
| 6 | Ensure that SOPs and record in proper place. | ||
| 7 | Ensure that label are properly affixed on the container. | ||
| 8 | Ensure that approved area is cleaned. | ||
Dispensing Area – Audit Checklist: |
|||
| 1 | Ensure that dispensing area is cleaned. | ||
| 2 | Ensure that pressure differential of dispensing area is maintained. | ||
| 3 | Ensure that balance are cleaned and calibrated. | ||
| 4 | Ensure that temperature & RH are with in the limit, and record are maintained. | ||
| 5 | Ensure that RLAF is cleaned. | ||
| 6 | Ensure that differential pressure of dispensing booth is updated. | ||
| 7 | Ensure that vacuum cleaner is cleaned & cleaning record is available. | ||
| 8 | Ensure that RM dispensing area sequential log is updated. | ||
| 9 | Ensure that pre filter is cleaned as per schedule. | ||
| 10 | Ensure that status board is updated. | ||
| 11 | Ensure that return riser is cleaned. | ||
| 12 | Ensure that dispensing utensils are cleaned and labeled. | ||
| 13 | Ensure that written procedure available for dispensing of raw material. | ||
| 14 | Ensure that line clearance is taken before starting the dispensing. | ||
| 15 | Ensure that one batch is dispense one at a time. | ||
Wash Area – Audit Checklist: |
|||
| 1 | Ensure that wash area is clean. | ||
| 2 | Ensure that label attached on the container having disinfectant solution and detergent solution. | ||
| 3 | Ensure that Disinfectant solution preparation record is updated. | ||
| 4 | Ensure that 2 %v/v non ionic detergent solution preparation record is updated. | ||
| 5 | Daily cleaning record is updated. | ||
| 6 | Ensure that utility lines are coded. | ||
| 7 | Ensure that daily housekeeping record is updated. | ||
Primary Packing Material Store – Audit Checklist: |
|||
| 1 | Ensure primary packing material store is cleaned. | ||
| 2 | Ensure that material, bag or box components shall be stored (over the pallet) off the floor. | ||
| 3 | Ensure that the format of primary packing material store is updated. | ||
| 4 | Ensure that temperature & RH are with in limit, and record are maintained. | ||
| 5 | Ensure that any written procedure is available for dispensing of primary packing material. | ||
| 6 | Ensure that primary packing material is properly arrange on the rack and Pallets. | ||
Secondary Packing Material Store – Audit Checklist: |
|||
| 1 | Ensure that secondary packing material store is cleaned. | ||
| 2 | Ensure that material, bag or box components shall be stored (over the pallet) off the floor. | ||
| 3 | Ensure that pallet are cleaned. | ||
| 4 | Ensure that door & window are cleaned. | ||
| 5 | Ensure that any written procedure is available for dispensing of secondary packing material. | ||
| 6 | Ensure that rejection room is under lock & key. | ||
| 7 | Ensure that the approved vendor list is available for receipt of material. | ||
Bonded Store Room (BSR) – Audit Checklist: |
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| 1 | Ensure that bounded store room is cleaned. | ||
| 2 | Ensure that temperature & RH are with in the limit, and record are maintained. | ||
| 3 | Ensure that material is checked before transfer to the finished good store. | ||
| 4 | Ensure that written procedure is available for transfer of material. | ||
| 5 | Ensure that door, window & glass are cleaned. | ||
| 6 | Ensure that check list is available during dispatch of product. | ||
| 7 | Ensure market return room is cleaned. | ||
| 8 | Ensure that market room is in lock & key. | ||
| Safety: | |||
| 1 | Ensure that HEPA filter validation are done as per requirement. | ||
| 2 | Ensure that MSDS of materials are available. | ||
| 3 | Ensure that all ware house personnel must be trained in departmental SOP. | ||
| 4 | Ensure that fire extinguisher are visible and accessible. | ||
| 5 | Ensure that all fire extinguisher are under validity. | ||
6.0 Audit checklist for Granulation Area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment |
| Granulation Area: | |||
| 1 | Ensure that granulation area is clean. | ||
| 2 | Ensure that pallets are cleaned. | ||
| 3 | Ensure that all the equipment are labeled properly. | ||
| 4 | Ensure that temperature and RH are with in the limit. | ||
| 5 | Ensure that pressure differential is maintained. | ||
| 6 | Ensure that riser are cleaned. | ||
| 7 | Ensure that doors, window, glass light -fixtures & light are cleaned. | ||
| 8 | Ensure that status board are updated. | ||
| 9 | Ensure that line clearance record are updated. | ||
| 10 | Ensure that daily cleaning record are updated. | ||
| 11 | Ensure that environmental monitoring record are updated. | ||
| 12 | Ensure that sieve utilization record are updated. | ||
| 13 | Ensure that FBD bag utilization record are updated. | ||
| 14 | Ensure that area waste bins are not overflowing. | ||
| 15 | Ensure that all equipments are calibrated and validated. | ||
| 16 | Ensure that all the pendants are properly cleaned and marked. | ||
| 17 | Ensure that hygrometers, balance and Maghnelic gauges having updated calibration labels. | ||
| 18 | Ensure that training record of personnel are available:(Check at least one person)
Name:___________ E. Code:___________ |
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| 19 | Ensure that dust collector are cleaned. | ||
| 20 | Ensure that equipment qualification tag is updated affixed on the machine. | ||
| 21 | Ensure that processing accessories are cleaned & labeled. | ||
| 22 | Ensure that sieve cabinet is clean properly. | ||
| 23 | Ensure that SOP index ix available. | ||
| 24 | Ensure that critical & noncritical equipment list are available. | ||
Blend Quarantine Area – Audit Checklist: |
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| 1 | Ensure that tablet quarantine area is cleaned properly. | ||
| 2 | Ensure that temperature & RH are with in the limit, and record are maintained | ||
| 3 | Ensure that daily cleaning record is updated. | ||
| 4 | Ensure that balance of quarantine area is calibrated and clean. | ||
| 5 | Ensure that area waste bins are not overflowing. | ||
| 6 | Ensure that all containers are proper labeled. | ||
| 7 | Ensure that pallets are cleaned. | ||
Wash Area – Audit Checklist: |
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| 1 | Ensure that wash area is cleaned. | ||
| 2 | Ensure that label attached on the container having disinfectant solution and detergent solution. | ||
| 3 | Ensure that Disinfectant solution preparation record is updated. | ||
| 4 | Ensure that 2 %v/v non ionic detergent solution preparation record is updated. | ||
| 5 | Daily cleaning record is updated. | ||
| 6 | Ensure that utility lines are coded. | ||
| 7 | Ensure that daily house keeping record is updated. | ||
| Safety: | |||
| 1 | Ensure that proper gowning, use of hand gloves, Nose mask & safety shoes is followed by the personnel during product handling. | ||
| 2 | Ensure that all fire extinguisher are under validity. | ||
| 3 | Ensure that fire extinguisher are visible and accessible. | ||
7.0 Audit checklist for Compression Area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment | ||||
| Compression Area: | |||||||
| 1 | Ensure that compression area is clean. | ||||||
| 2 | Ensure that pallets are cleaned. | ||||||
| 3 | Ensure that all the equipment are labeled properly. | ||||||
| 4 | Ensure that temperature and RH are with in the limit & record are maintained. | ||||||
| 5 | Ensure that pressure differential is maintained. | ||||||
| 6 | Ensure that riser are cleaned. | ||||||
| 7 | Ensure that door, window, glass light -fixtures & light are cleaned. | ||||||
| 8 | Ensure that status board are updated. | ||||||
| 9 | Ensure that line clearance record are updated. | ||||||
| 10 | Ensure that daily cleaning record are updated. | ||||||
| 11 | Ensure that SOP index is available. | ||||||
| 12 | Ensure that equipment qualification tag are updated affixed on the machine. | ||||||
| 13 | Ensure that processing accessories are cleaned & labeled. | ||||||
| 14 | Ensure that area waste bins are not overflowing. | ||||||
| 15 | Ensure that all equipments are calibrated and validated. | ||||||
| 16 | Ensure that all the pendants are properly cleaned and marked. | ||||||
| 17 | Ensure that hygrometers, balance and Maghnelic gauges having updated calibration labels. | ||||||
| 18 | Ensure that training record of personnel are available:(Check at least one person) Name:________ E. Code:_________ | ||||||
| 19 | Ensure that dust collector are clean. | ||||||
Compression Tool Room – Audit Checklist: |
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| 1 | Ensure that all punches are properly cleaned, lubricated & coded. | ||||||
| 2 | Ensure that all the format related with tool room are updated:
i) Punch die audit record. ii) Punch and die cabinet label. iii) Tool set index. iv) Punch and die destruction scrap note. v) Punch and die cabinet cleaning record. |
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| 3 | Ensure that punch audit kit & polishing kit are available for punch audit and polishing. | ||||||
| 4 | Ensure that tool box are clean. | ||||||
| 5 | Ensure that written procedure is available for procurement, Issuance, handling, cleaning, audit and rejection of punches & dies. | ||||||
IPQC Area – Audit Checklist: |
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| 1 | Ensure that IPQC are cleaned. | ||||||
| 2 | Ensure that all IPQC instrument are cleaned & Calibrated. | ||||||
| 3 | Ensure that log book of IPQC equipment are updated. | ||||||
| 4 | Ensure that standard weight box are calibrated & standard weight box Code No._____________________ | ||||||
| 5 | Ensure drain point are cleaned. | ||||||
| 6 | Ensure that area, door, windows, glasses & light are cleaned. | ||||||
Tablet Quarantine Area – Audit Checklist: |
||||||
| 1 | Ensure that tablet quarantine area are clean properly. | |||||
| 2 | Ensure that temperature & RH are with in limit, and record are maintained. | |||||
| 3 | Ensure that daily cleaning record are updated. | |||||
| 4 | Ensure that balance of quarantine area are calibrated and clean. | |||||
| 5 | Ensure that area waste bins are not overflowing. | |||||
| 6 | Ensure that all containers are proper labeled. | |||||
| Audit Area: | ||||||
| 1 | Ensure that audit area are cleaned. | |||||
| 2 | Ensure that all pallets are cleaned. | |||||
| 3 | Ensure that daily cleaning record is updated. | |||||
| 4 | Ensure that line clearance record is updated. | |||||
| 5 | Ensure that environmental monitoring record is updated. | |||||
| Wash Area: | ||||||
| 1 | Ensure that wash area are clean. | |||||
| 2 | Ensure that label attached on the container having disinfectant solution and detergent solution. | |||||
| 3 | Ensure that Disinfectant solution preparation record is updated. | |||||
| 4 | Ensure that 2 %v/v non ionic detergent solution preparation record is updated. | |||||
| 5 | Daily cleaning record is updated. | |||||
| 6 | Ensure that utility lines are coded. | |||||
| 7 | Ensure that daily house keeping record is updated. | |||||
| Safety: | ||||||
| 1 | Ensure that proper gowning, use of hand gloves, Nose mask & safety shoes is followed by the personnel during product handling. | |||||
| 2 | Ensure that all fire extinguisher are under validity. | |||||
| 3 | Ensure that fire extinguisher are visible and accessible. | |||||
8.0 Audit checklist for Coating Area
| Sr. No. | Check Points | Complies/ Not Complies / NA | Comment | |
| Coating Area: | ||||
| 1 | Ensure that coating area is cleaned. | |||
| 2 | Ensure that pallets are cleaned. | |||
| 3 | Ensure that all the equipment are labeled properly. | |||
| 4 | Ensure that temperature and RH are with in the limit & record are maintained | |||
| 5 | Ensure that pressure differential is maintained. | |||
| 6 | Ensure that riser are cleaned. | |||
| 7 | Ensure that door, window, glass light -fixtures & light are cleaned. | |||
| 8 | Ensure that status board are updated. | |||
| 9 | Ensure that line clearance record are updated. | |||
| 10 | Ensure that daily cleaning record are updated. | |||
| 11 | Ensure that SOP index is available. | |||
| 12 | Ensure that equipment qualification tag are updated & affixed on the machine. | |||
| 13 | Ensure that processing accessories are cleaned & labeled. | |||
| 14 | Ensure that area waste bins are not overflowing. | |||
| 15 | Ensure that all equipments are calibrated and validated. | |||
| 16 | Ensure that all the pendants are properly cleaned and marked. | |||
| 17 | Ensure that hygrometers, balance and maghenelic guages having updated calibration labels. | |||
| 18 | Ensure that training record of personnel are available:(Check at least one person) Name: ______Code:_____________ | |||
Solution Preparation Area – Audit Checklist: |
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| 1 | Ensure that solution preparation room cleaned. | |||
| 2 | Ensure that pallets cleaned. | |||
| 3 | Ensure that all the equipment are properly labeled. | |||
| 4 | Ensure that riser cleaned. | |||
| 5 | Ensure that door, window, glasses & light cleaned. | |||
| 6 | Ensure that status board updated. | |||
| 7 | Ensure that line clearance record updated. | |||
| 8 | Ensure that daily cleaning record updated. | |||
| 9 | Ensure that environmental monitoring record updated. | |||
| 10 | Ensure that area waste bins not overflowing. | |||
| 11 | Ensure that all equipments calibrated and validated. | |||
| 12 | Ensure that all the pendants properly cleaned and marked. | |||
| 13 | Ensure that drain point cleaned. | |||
| Wash Area: | ||||
| 1 | Ensure that wash area is clean. | |||
| 2 | Ensure that label attached on the container having disinfectant solution and detergent solution. | |||
| 3 | Ensure that Disinfectant solution preparation record updated. | |||
| 4 | Ensure that 2 %v/v non ionic detergent solution preparation record updated. | |||
| Safety: | ||||
| 1 | Ensure that fire extinguisher are visible and accessible. | |||
| 2 | Ensure that proper gowning,use of hand gloves, Nose mask & safety shoes are followed by the personnel during product handling. | |||
| 3 | Ensure that all fire extinguisher are under validity. | |||
9.0 Audit checklist for Packing Area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment | ||||||
| Primary Packing Area: | |||||||||
| 1 | Ensure that area waste bins are not overflowing. | ||||||||
| 2 | Ensure that blister area is clean. | ||||||||
| 3 | Ensure that pallets are cleaned. | ||||||||
| 4 | Ensure that equipment are proper labeled. | ||||||||
| 5 | Ensure that temperature and RH are with in the limit & record are maintained. | ||||||||
| 6 | Ensure that pressure differential is maintained. | ||||||||
| 7 | Ensure that riser are cleaned. | ||||||||
| 8 | Ensure that door, window, glass light -fixtures & light are cleaned. | ||||||||
| 9 | Ensure that status board are updated. | ||||||||
| 10 | Ensure that packing line clearance record are updated. | ||||||||
| 1 | Ensure that daily cleaning record are updated. | ||||||||
| 12 | Ensure that SOP index is available. | ||||||||
| 13 | Ensure that equipment qualification tag are updated affixed on the machine. | ||||||||
| 14 | Ensure that processing accessories are cleaned & labeled. | ||||||||
| 15 | Ensure that all equipments are calibrated and validated. | ||||||||
| 16 | Ensure that all the pendants are properly cleaned and marked. | ||||||||
| 17 | Ensure that hygrometers and maghenelic guages having updated calibration labels. | ||||||||
| 18 | Ensure that toolbox is free from rubber stereos and tablets of previous product/batch | ||||||||
| 19 | Ensure that SOP of cleaning & operation of equipments are in place. | ||||||||
Secondary Packing Area – Audit Checklist: |
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| 1 | Ensure that secondary packing area is clean. | ||||||||
| 2 | Ensure that check weigher calibration, performance & labeling record are updated. | ||||||||
| 3 | Ensure that pallets are cleaned. | ||||||||
| 4 | Ensure that empty shipper are kept on the pallets. | ||||||||
| 5 | Ensure that area waste bins are not overflowing. | ||||||||
| 6 | Ensure that proper label attached on the packed shippers. | ||||||||
| 7 | Ensure that packing line clearance record are updated. | ||||||||
| 8 | Ensure that training record of personnel are available:(Check at least one person)
Name:___________ E. Code:__________ |
||||||||
| Wash Area: | |||||||||
| 1 | Ensure that wash area are clean. | ||||||||
| 2 | Ensure that label attached on the container having disinfectant solution and detergent solution. | ||||||||
| 3 | Ensure that Disinfectant solution preparation record is updated. | ||||||||
| 4 | Ensure that 2 %v/v non ionic detergent solution preparation record is updated. | ||||||||
| 5 | Ensure that utility lines are coded. | ||||||||
| 6 | Ensure that daily house keeping record is updated. | ||||||||
| Safety: | |||||||||
| 1 | Ensure that fire extinguisher are visible and accessible. | ||||||||
10.0 Audit checklist for Personal and Admin (HR) Area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment | |
| P & A Area: | ||||
| Personnel | ||||
| 1 | Ensure that list of person working in unit . | |||
| 2 | Ensure that medical examination done for new entrant. | |||
| 3 | Ensure that physician conducting for medical examination are qualified /approved. | |||
| 4 | Ensure that periodic medical examination carried out as per pre defined procedure. | |||
| Sanitization and Hygiene | ||||
| 1 | Ensure that written procedure for sanitization are avaliable. | |||
| 2 | Ensure that saitisation done as per per defined frequency & updation of records. | |||
| Linen | ||||
| 1 | Ensure that area are segregated for storing of clean linen. | |||
| 2 | Ensure that sufficient uniform for all employees. | |||
| Change room | ||||
| 1 | Ensure that SOP for gowning displayed in change room. | |||
| 2 | Ensure that facility for keeping personal clothes & footwear. | |||
| 3 | Ensure that disinfectenting solution kept in change room. | |||
| 4 | Ensure that washing facility for footwear. | |||
Building & Surrounding |
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| 1 | Ensure that area around the building are cleaned. | ||
| 2 | Ensure that wastage from nearby factories not come in contact with building. | ||
| 3 | Ensure that ETP found satisfactory to ensure that it complies with local pollution control authority . | ||
| Security system | |||
| 1 | Ensure that all man & material movement inside factory premises observed & checked through security system. | ||
| 2 | Ensure that visitor & person visited factory been documented. | ||
| 3 | Ensure that flame arrester provided in vehicles. | ||
11.0 Audit checklist for Microbiology Area
| QC Micro Area: | |||
| 1 | Ensure that area waste bins are not overflowing. | ||
| 2 | Ensure that all cupboards are cleaned. | ||
| 3 | Ensure that no unwanted items are inside the cupboard. | ||
| 4 | Ensure that calibration label is affix on each instrument/ equipments. | ||
| 5 | Ensure that the all instrument/ equipments are calibrated. | ||
| 6 | Ensure that all instrument/equipments log books are kept in the place. | ||
| 7 | Ensure that instrument/equipments are cleaned. | ||
| 8 | Ensure that all chemicals (Solid & liquid) are properly labeled & within its validity. | ||
| 9 | Ensure that temperature & humidity record are maintained of the lab and is within the specified limit. | ||
| 10 | Ensure that all log books & documents are properly labeled. | ||
| 11 | Ensure that calibration records for all instrument/equipments are available and reviewed | ||
| 12 | Ensure that all log books are checked on daily basis. | ||
| Environmental, Health and Safety: | |||
| 1 | Ensure that proper gowning, use of hand gloves, Nose mask & safety shoes are followed by the personnel. | ||
| 2 | Ensure that all employees must be trained in departmental SOPs, GMP and Safety related procedure. | ||
| SOPs and Documentation: | |||
| 1 | Ensure that SOP Files are accessible and filed properly. | ||
| 2 | Ensure that superseded versions have been returned to QA. | ||
| 3 | Ensure that all log book entries are properly filled and updated. | ||
| 4 | Ensure that control sample area monitoring record is available and updated. | ||
| 5 | Ensure that QC Micro analytical report are filled properly. | ||
| 6 | Ensure that training record of personnel are available:(Check atleast one person)
Name:____________ E. Code:_______________ |
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| Washing Area: | |||
| 1 | Ensure that washing room is cleaned | ||
| 2 | Ensure that all glassware is kept in designated place. | ||
| 3 | Ensure that all the pendants are properly cleaned and marked. | ||
12.0 Audit checklist for Microbiology Area
| Sr. No. | Check Points | Complies/ Not Complies/NA | Comment | ||
| QA Area: | |||||
| 1 | Ensure that current SOP’s and index of all SOP’s are updated & available in department. | ||||
| 2 | Ensure that set of all SOP’s organized according to index. | ||||
| 3 | Ensure that SOP available for control & distribution of master document. | ||||
| 4 | Ensure that record of distribution of document are updated. | ||||
| 5 | Ensure that all SOP’s are effective after training of respective SOP. | ||||
| Personnel : | |||||
| 1 | Ensure that training record of employees are updated ,check training record of any one employee of department.
Employee name: Employee code: |
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| 2 | Ensure that written job responsibility available of all employees. | ||||
Documentation & Records : |
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| 1 | Ensure that changes that may impact product quality authorized by QA before implementation. | ||||
| 2 | Ensure that Closing status of change control up-dated in register. | ||||
| 3 | Ensure that Self audit done as per defined frequency in SOP. | ||||
| 4 | Ensure that issuance of batch record do as per SOP. | ||||
| 5 | Ensure that record of batch issuance record /register updated. | ||||
| 6 | Ensure that Market complaint closed with in time limit ,if not then any written procedure available for extension of closing date of complaints. | ||||
| 7 | Ensure that Numbering system of Market complaint do as per SOP. | ||||
| 8 | Ensure that Event investigation reporting handle as per SOP. | ||||
| 9 | Ensure that register of Event investigation reporting up-dated as per SOP. | ||||
| 10 | Ensure that Event closed with in time limit ,if not then have any written procedure for target extension date. | ||||
| 11 | Ensure that Handling of return material do as per SOP as well as up-date to document. | ||||
| 12 | Ensure that up-date the product list. |
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| 13 | Ensure that updated List of equipment are available in department. | ||||
| 14 | Ensure that Process validation perform of new introduced products as per SOP. | ||||