Self Inspection Check List (Quality Control)

Annexure –  VIII Self Inspection Check List (Quality Control)

Sr. No.	Check Points	Yes / No		Remarks
General :
01	Are objective and principles of cGMP understood and applied?		Yes / No
	Does each section have relevant standard operating procedures [SOPs]?		Yes / No
03	Are all analytical activities & procedures related to APIs validated initially and reviewed periodically?		Yes / No
04	Are training conducted as per training programme? Check the record available and update		Yes / No
05	Is every person aware of company's quality policy		Yes / No
06	Has the quality control laboratory got adequate equipment for the performance of QC functions		Yes / No
Cleaning and General housekeeping
01	Is cleaning done regularly?		Yes / No
02	Is pest control maintained in the laboratory?		Yes / No
03	Is glassware cleaned properly?		Yes / No
04	Are working benches and records cabinets checked for the cleanliness regularly?		Yes / No
Raw material testing
01.	Are master specifications and method of analyses for all raw materials are available?		Yes / No
02.	Are they written and approved by two responsible officials?		Yes / No
03.	Is raw material analysis register/note book maintained? Check records of any two raw materials.		Yes / No
04.	Are raw material records checked by Q.C. Officer / manager?		YES/NO
05.	Check the Traceability of Raw materials & records as per Q.C. ref. No. [Control No.].		Ok/Not Ok
06	Are records related to preparation & Standardization of working standard available and maintained?		Yes / No
07.	Check Working standards for following‑ -Label -Storage -WS No. -effective date /use before date		Ok/Not Ok
08.	Are primary standards of Raw materials -Checked -Identified -Original bottles preserved -Records		Ok/Not Ok
09	Are IR/UV chart of RM available		Ok/Not Ok
10	Do available records tally with each other for content?		Ok/Not Ok
11	Does Q.C./warehouse assign control No./Q.C. Ref no. in FIFO.		Ok/Not Ok
12	Does `sampled' sticker pasted on a container from which sample is taken? [check as per SOP]		Ok/Not Ok
13	Are sample bottles labeled properly		Ok/Not Ok
14	Does under test label on all container, from which sample are taken.		Ok/Not Ok
In-process & finished product testing
01	Check reference standards (IP/BP/USP): -Lot No -Storage condition -usage instruction		Ok/Not Ok
02	Are master specification & test method are available for all in-process & finished product.		Yes/No
02	Are master specification & test method are available for all in-process & finished product.		Yes/No
03	Check and verify the specifications and test procedures are in compliance with those registered with Marketing Authorization / submitted ANDA for a few products.		Yes/No
04	Intimation test reports (ITR) are properly filed.		Ok/Not Ok
05	Are graphs, chromatogram, ITR is preserved?		Yes/No
06	Are test protocols/Chemist note book checked For a)Correctness, as per specifications b)         Signatures		Yes/No
07	Certificate of analysis of finished product for every product is feeded in computer.		Yes/No
08	Are analytical method Validation for finished product		Ok/Not Ok
09	Are calibration records of following Q.C. instruments available HPLC, GC, IR, UV, POLARIMETER etc.,		Yes/No
10	Are Q.C. instrument labeled accordingly?		Yes/No
11	Check the Calibration tag for a) Instrument names and tags no. b) Calibration  on c) Next calibration due on d)         Calibrated by (Initial)		Yes/No
12	Are the laboratory reagent and other chemicals supplied, identified, tested and expiration dated?		Yes/No
13	Are there Procedures for the preparation, standardization storage and usage working standard / reference method?		Yes/No
Packaging material
01	Is master specification s & test method for all Packaging material available?		Yes/No
02.	Are all SOPs available for each equipment		Yes/No
03.	Are packaging materials examined by Q.C.		Yes/No
04.	Is record of packaging material testing maintained.		Yes/No
05.	Are they approved against master label, printed packing material		Yes/No
06.	Check the Temperature record of control (Reserve) samples.		Ok/Not Ok
07.	Check the calibration tags & calibration record of packaging material lab instrument		Ok/Not Ok
Microbiology lab
01.	Are all specification & GTP's available		Yes/No
02.	Are all related SOPs are available for each area		Yes/No
03.	Is entry procedure to sterility test area defined and followed.		Yes/No
04.	Are records kept for a) Standardization b) Fumigation c) Sub-culturing d) Cleaning of Laminar Flow/Area		Ok/Not Ok
05	Are methods used in micro lab validated?		Yes/No
06	Are growth promotion properties of each batch of medium tested?		Yes/No
07	Check the followings No. of sterility repetitions Bacterial counts exceeding limits Investigation / action taken reports [if, any]		Yes/No
08	Check the record for Endotoxin testing is completed?		Yes/No
09	Check the water testing reports are complete and updated?		Ok/Not Ok
10	Check the area temp. Monitoring record of incubators are maintained?		Yes/No
11	Check the calibration records of micro lab?		Ok/Not Ok
12	Validation record of Autoclave available?		Yes/No
13	Cleaning records pre-filters, Autoclave etc. match with expected numbers?		Ok/Not Ok
Stability lab
01	Stability study conducted as per current guidelines?		Yes/No
02.	Check the supporting documents / spectra / TLC plates and date of stability study		Ok/Not Ok
03.	Check the Temperature & humidity record of stability room.		Ok/Not Ok
04.	Check the protocol are available for every product kept on stability		Ok/Not Ok
05.	Check the validation of stability of stability indicating method		Ok/Not Ok
06.	Does the physical inventory of these samples		Yes/No
Sr. No.	Check Points		Yes / No
6.0	Specification and STPs		Yes / No
6.1	Availability of Current version of STPs		Yes / No
6.2	Availability of Current version of  Specifications		Yes / No
6.3	List of current version of STPs		Yes / No
6.4	List of current version of Specifications		Yes / No
7.0	Documentation		Yes / No
7.1	GRN		Yes / No
7.2	Preservation of Raw data		Yes / No
7.3	Final report		Yes / No
7.4	Is Good Documentation practice being followed		Yes / No
8.0	Training Program		Yes / No
8.1	Training schedule		Yes / No
8.2	Training needs identification		Yes / No
8.3	Training records of personnel		Yes / No
9.0	Out Of Specification		Yes / No
9.1	Is there SOP for Out of Specification		Yes / No
9.2	Is there any Out of Specification		Yes / No
9.3	Records are available for Out of Specification		Yes / No
10.0	Qualification of Analyst		Yes / No
10.1	Is there a SOP for Qualification of analyst		Yes / No
10.2	Is the analyst Qualified as per the SOP		Yes / No
11.0	Working and Reference Standards		Yes / No
11.1	Is there a List of reference Standards		Yes / No