Follow
1 Departmental Organogram
2 Job responsibilities for newly joined employees are available
3 Persons engaged in analytical activity
i) Clean uniform
ii) Sterile garments for microbiology
4 SOP on cleaning
i) Glass apparatus
ii) General cleaning of department
iii) Specific area
5 Toilet facilities available
i) Adequate
ii) Clean
iii) Well ventilated
iv) Segregated from working area
6 Prohibited in working area
i) Smoking
ii) Chewing tobacco
iii) Eating /Drinking
7 Health checks for all personnel
i) Pre-employment
ii) Yearly
iii) Record
8 Safety
i) Fire extinguishers – adequacy
ii) First aid – adequacy
iii) Possibility of potential electrical hazards
9 Acceptance of RM & PM
i) Vendor list available
10 Received material
i) Sampling plan
ii) Sampled quantity
11 Testing and test related documentation
11.1 Specifications and STPs
i) Current
ii) Revision procedure
iii) Validation
iv) Authorisation
11.2 Documentation
i) Material Receiving Report
ii) Preservation of original data
iii) Final report
iv) Communication of status to related department
– Purchase
– Warehouse
– Accounts
– Production planning
– Product Development lab
11.3 Retesting procedure (all the tests are performed as per statutory requirements)
11.4 Collection of retained sample and retrieval system.
11.5 Working standards & reference standards
– Maintenance
– Documentation
12 In-process analysis (Spec and STP)
i) Current
ii) Revision procedure
iii) Validation
iv) Authorisation
13 Documentation
i) Sampling
ii) Tests performed
iii) Feedback procedure
iv) All the relevant logbooks are available and bound log books are in practice
14 Finished product analysis
14.1 Specification and STPs
i) Current
ii) Revision procedure
iii) Validation
iv) Authorisation
14.2 Testing
i) Physical
ii) Chemical
iii) Microbiological
14.3 Certificate of analysis
i) Primary data
ii) Checking of calculations
iii) Preservation of primary data
15 Control samples
i) Collection procedure
ii) Sample size
iii) Storage
iv) Retrieval system
v) Disposal
vi) Documentation
16 Instruments SOPs of Operation, Maintenance & Calibration
i) Operational logbooks are available and bound log books are in practice
ii) Calibration
iii) Documentation
17 Standardization of volumetric solution and documentation
18 Stability study
i) List of products under stability study
ii) Stability protocols & reports
iii) Temp & %RH monitoring records of the stability chambers
19 Investigation of OOS/OOT
20 Management of HPLC/GC columns
21 List of reagents & solvents
22 Document archiving & retrieval system
23 Management of analytical worksheets
23.1 Instrument IDs are mentioned in the analytical worksheets
24 Online documentation system
25 Microbiology Lab
25.1 Stock stains available
25.2 Microbial culture management
i) Name of organisms
ii) ATCC/NCTC numbers
iii) Sub-culturing of organisms
iv) Preservation of microbial culture
25.3 Disposal of microorganism, used culture media, used plates etc.
25.4 Testing area
i) Adequacy of space
ii) Adequacy of equipment
iii) Cleanliness
25.5 Environmental monitoring records
25.6 Water monitoring records
25.7 Growth promotion records of media
25.8 Calibration records
25.9 Validation of autoclave machine
25.10 Validation of LAF
25.11 Operational logbooks are available and bound log books are in practice
25.12 Master list of SOP, Specification & STPs are updated
