Self Inspection Check List (Quality Assurance)

Annexure – IX Self Inspection Check List (Quality Assurance)

Sr. No.	Check Points	Yes / No	Remarks
Generals:
01	Does each section have relevant standard operating procedures [SOPs]?	Yes / No
02	All the persons working in the Quality Assurance Department are trained with job responsibilities of Quality Assurance Department and Quality Policy of the Company.	Yes / No
03	All the documents are kept in Lock and key.	Yes / No
04	All the documents are approved by responsible QA officials?	Yes / No
05	Are documentation control system     for obsolete and master documents are adequately controlled and kept properly like BPR, SOPs etc.	Yes / No
06	Induction training conducted for new employees? If yes, training index, module and record of induction training are updated.	Yes / No
07	Are the change controls logging and evaluation of change control is updated? Check the record.	Yes / No
08	Are the SOPs / Master Manufacturing records are properly documented & reviewed by QA.	Yes / No
09	Are Self Audit were done as per plan? Check the records. Are Audit Observations of self audit are complied?	Yes / No
10	Available Validation Protocols are properly documented / reviewed by QA. Check the Protocol (if required)	Yes / No
11	Qualification documents (IQ/OQ/PQs) are available? Arranged properly and segregated plant wise?	Yes / No
12	Are Control /Referenced samples of finished product are maintained for a period of at least one year after date of joining	Yes / No
13	Annual product review of all products are available in QA according to year wise	Yes / No
14	Are Site Master File for all plants is updated?	Yes / No
15	Out of Specifications are prepared along with its justifications are properly documented. Check the Record (if required)	Yes / No
16	Facility            Audit   Compliances    are       properly documented and check the observations are complied	Yes / No
17	Market Complaints      are       investigated     and documented properly.	Yes / No
18	SOP distribution log is logged in properly and documented.	Yes / No
19	Master of BPR, SOP and other documents are kept for review and reference purpose in QA	Yes / No
20	Master and other documents are destroyed properly with prior authorization.	Yes / No
21	Annual product review of all products are available in QA according to year wise	Yes / No
22	Are Site Master File for all plants is updated?	Yes / No
23	Out of Specifications are prepared along with its justifications are properly documented. Check the Record (if required)	Yes / No
24	Facility            Audit   Compliances    are       properly documented and check the observations are complied	Yes / No
25	Training Modules of the respective departments are available?	Yes / No
26	Does Quality Assurance have authority to approve /reject plant, equipment, process and procedure changes?	Yes / No
27	Deviations are prepared along with its justifications are properly documented. Check the Record (if required)	Yes / No
28	Are Master Validation Plan manufacturing plants updated? It is received and approved by Quality Assurance Person?	Yes / No
29	Are blank Batch Production Records by responsible individual and as per SOP issued?	Yes / No
30	Check traceability of executed production records, which is kept properly batch?	Yes / No
Cleaning and General housekeeping
01	Is cleaning done regularly?	Yes / No
02	Is pest control maintained in the department?	Yes / No
03	Are working benches and records cabinets checked for the cleanliness regularly?	Yes / No
04	Windows and Doors are checked for the cleanliness regularly?	Yes / No
Specific point related to c GMP of Regulatory Body
01	Batch certification  as per customer requirement/regulatory agencies	Yes / No
02	Technical  Agreement	Yes / No
03	Good distribution practices	Yes / No
04	Notification of change to respective customers	Yes / No
05	Assessment of the marketing application & manufacturing authorization	Yes / No
06	Procedure for release of batches as per respective customer regulations	Yes / No
07	Verification of manufacturing authorization or product license.	Yes / No
08	Rapid alert notification of a quality defects.	Yes / No