1 Departmental Organogram
2 Job responsibilities for newly joined employees are available
3 Training record available
4 Health check programme
i) All new employees are medically checked before employment and certified fit
ii) All new employees are medically examined at least once in a year
iii) Details major illness available
iv) Details of communicable diseases, open lesion etc. available
5 Garments and uniforms
6 Sufficient number of clean uniforms available
7 Is specified area uniform are made of lint free material to prevent particle shedding
8 The normal range of uniforms includes
i) Caps or hair covers
ii) Beard and moustache cover
iii) Factory foot wears
iv) Nose and mouth masks
v) Gloves
vi) Cover all
vii) Safety glasses / protective glasses
9 Standard Operating Procedure available for
i) Gowning and de-gowning procedure
ii) Training and development and its evaluation
10 Building and facilities
i) Layouts
ii) Maintenance records
11 Design and construction features
i) Suitable in size and surfaces
ii) Suitable for cleaning
iii) Suitable for maintenance
iv) Suitable for Operations
v) Suitable for material handling
12 Adequate space for equipment
i) Cleaning
ii) Operation
iii) Maintenance
13 Different activities are carried out in different area
i) Separate area available for material receiving from
warehouse
ii) Separate area available for in-process material
iii) Separate area available and used for manufacturing,
checking / sorting packing
iv) Separate area available for packed finished goods awaiting transfer to finished goods warehouse
v) Quarantine area for unreleased finished packs
vi) Separate area available for IPQC testing in production facilities
14 Adequate lighting is provided in all area.
15 Adequate ventilation provided.
16 Temp. , Humidity and dust levels are adequate.
17 Plumbing
Potable water is supplied under continuous positive pressure
18 Drains are of adequate size and adequate mechanical device to prevent back siphonage. They are regularly disinfected.
19 Sewage and refuse
i) Sewage, trash and other refuse in and from the
building and immediate premises is disposed off in a
safe and sanitary manner.
20 Washing and toilet facilities are adequate
21 Adequate washing facilities are provided
Which include
Water
Soap / detergent
22 Sanitation
i) Premises are kept clean and in well sanitized conditions
23 Written SOPs available for
i) Area cleaning and sanitation
24 Maintenance
i) Building are well maintained condition
ii) Records of repairs kept
iii) Water leakage are not there
iv) Dust extraction are not effective
25 Documents – following documents are available:
i) Environmental control records (wherever applicable)
ii) Preventive maintenance programme
iii) Water analysis
iv) Job responsibility of sanitary supervisor
v) Record of building and service repairs done
vi) Validation report of Purified Water system.
vii) Validation report of HVAC and dust extraction systems.
viii) Equipment maintenance
26 SOP available for
i) Cleaning and sanitation of areas
ii) Maintenance of building and services
27 Equipments
i) Equipments are suitably located
28 Equipment can be easily cleaned
Operated
Maintained
29 Equipment generate minimum dust
30 All equipment possess unique identification numbers
31 All equipments are validated for their use
32 All equipment have status labels all the time
i) Status label become a part of the BPR
33 Instruments / gauges used along with the equipment are calibrated and record maintained
34 Documents- following documents are available
i) List of equipment with unique numbers
ii) Equipment validation reports
iii) Preventive maintenance reports
iv) Records of repair, cleaning/sanitation and inspection/certification of equipment
35 Dispensing operation ensure
i) Identification
ii) Quantity
iii) Avoid contamination
36 Production and process control
36.1 Written procedures and deviations
i) All written procedures are reviewed routinely and revised ,if required
ii) SOP compliance is verified
36.2 Change-in of components
i) Weighing measuring and sub-dividing operations of components are examined by a second person
ii) Each component is added to the batch by one person and verified by another person
36.3 Calculation of yield
i) Actual yield and percentage yields are determined at the conclusion of each appropriate phase
37 Equipment identification
i) All equipment and storage containers are identified at all the time
ii) Major equipment/lines are identified by unique identification number
38 Sampling and testing of in-process materials
i) Inprocess controls are described in writing
ii) Rejected in-process materials are identified and controlled under a quarantine system
iii) Records of destruction of rejected materials are maintained
39 Time limitations on production
i) Time limitations for completion of each phase of production are available and followed
ii) Deviation, if any ,are justified and documented
40 Documents
i) Self inspection reports available
ii) In-process specification available
41 Following SOPs are available:
i) SOP on SOP
ii) Self inspection
iii) Deviation procedure
iv) Change Control Procedure
v) Relevant masters lists
vi) Function check of balances
42 Packaging and labelling operations
i) Written procedure exits to assure that correct labels and labelling and packaging materials are used
ii) Bulk product and packing materials are well registered
iii) Packed goods awaiting transfer to FG ware house are well segregated
iv) Suitable dust extraction system exist whenever required
v) Bulk material containers and hoppers are well closed and correctly identified
vi) Different, but similar looking product lines are run at sufficient distance
vii) Packaging lines are not started unless all packing materials required for the batch are available
viii) During lunch and tea breaks and shift closure no containers are kept without seal
ix) Packing lines are having line boards prominently displayed to indicate current operations
43 Drugs product inspection
i) Packed and labelled products are examined during packaging/labeling operations and records maintained
ii) Reserve samples are collected
iii) In-process examination results are kept in BPR
iv) Expiration dating
v) Expiration dates appear on the labeling in accordance with the requirements of the law
44 Documents
i) Records of packaging operation of each batch available.
ii) Records of destruction of rejected packaging material available.
45 Equipment cleaning and use log
i) Written records in suitable form for equipment cleaning, usage and repairs is available
ii) Batch production and control record available
iii) BPR is available for each batch produced
iv) BPR always accompanies the production phase
v) Line clearance is done routinely
vi) Line clearance records are maintained