Follow
1 Departmental Organogram
2 Job responsibilities for newly joined employees are available
3 Toilet facilities available
i) Adequate
ii) Clean
iii) Well ventilated
iv) Segregated from working area
4 Prohibited in working area
i) Smoking
ii) Chewing tobacco
iii) Eating /Drinking
5 Health checks for all personnel
i) Pre-employment
ii) Yearly
iii) Record
6 Safety
i) Fire extinguishers – adequacy
ii) First aid – adequacy
iii) Possibility of potential electrical hazards
7 Testing area (IPQA)
i) Adequacy of space
ii) Adequacy of equipment
iii) Cleanliness
8 Vendor Management
i) Vendor list is available
ii) Vendor audit schedule & audit reports are available
iii) Supplier performance review reports are available
9 Self Inspection schedule, checklist & reports are available
10 Validation reports of facility, process & equipment are available
11 Annual Product Review reports are available
12 Change Control Reports
i) Log register of change control reports checked
ii) Total number of change controls in the current year
13 Deviation Reports
i) Log register of deviation reports checked
ii) Total number of deviations in the current year
14 Master lists of SOPs/Formats/Products/Approved Vendors/Equipments/ etc. are available
15 Material code master list is available
16 Sampling of finished products
17 Control samples
i) Collection procedure
ii) Sample size
18 Batch Documentation
i) BMR/BPR completion/review
ii) Collection
iii) Archiving system
iv) Retrieval system
v) Disposal records
vi) Availability of distribution records
iv) Documentation
19 Instruments SOPs of Operation, Maintenance & Calibration
i) Equipment logbook
ii) Calibration
20 Market Complaints
i) SOP
ii) Documentation
iii) Feed back
21 Product recall procedure
22 Risk Assessment log register is available
23 Follow up of CAPAs
