Audit Checklist – Department wise in Pharmaceuticals

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:_______________

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:_______________

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:

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:

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:_______________

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

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:

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:

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:___________

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:

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:

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:

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.

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:

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:

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:

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

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:_______________

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:

2 Ensure that written job responsibility available of all employees.

Documentation & Records :

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.  

 

13 Ensure that updated  List of equipment are available in department.
14 Ensure that Process validation perform of new introduced products as per SOP.

 

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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