Procedure for self inspection 2 of 2

K. Methods Validation
1		Have all in-house methods been validated?
2		Is there a written SOP relating to the validation of analytical methods?
3		Does methods validation provide data to demonstrate ¨       Linearity? ¨       System precision? ¨       Method precision? ¨       Method specificity? ¨       Method sensitivity? ¨       Method ruggedness? ¨       Accuracy? ¨       Solution stability? ·         Robustness?
Microbiology
Sr. No.		Requirements		Compliance							Remarks
				Yes		No		N/A
	A. SOPs
	1		Are a complete index of SOP, STP available.
	B. Personnel
	1		Are the training records of the employees working in the department up-to-date?
	2		Have the employee’s undergone training as per their job.
	3		Are detailed, written job descriptions available for all employees?
	C.  Facilities
	1		Is the laboratory maintained in a good state of repair?
	2		Is the laboratory neat and orderly with sufficient space for equipment and operations?
	3		Is the good housekeeping followed?
	4		Are the laboratory instruments / equipments are qualified
	5		Is the clean room maintained in a good state of repair?
	6		Is there an SOP for the cleaning and disinfection of the clean room?
	7		Are there records of the preparation of disinfectants?
	8		Are disinfectants labelled with expiration dates?
	9		Are cleaning records available and correctly filled out?
	D. Equipment and Instrumentation
	1		Is there an approved preventive maintenance program for all equipment used in the laboratory?
	2		Is there evidence that it is followed?
	3		Is there an approved calibration schedule for all instrumentation in the laboratory?
	4		Is there evidence that it is followed?
	5		Are there written procedures for operating the equipment?
	6		Is there a valid calibration sticker on each instrument?
	7		Are temperature recorders attached to all incubators and refrigerators?
	8		Are there an approved SOP that requires the routine checking and signing of temperature charts?
	9		Is there an SOP defining cleaning and sanitization procedures for the incubators and refrigerators?
	10		Is there documented evidence that it is being followed?
	11		Examine the most recent validation file for the autoclave.
	12		Was the validation performed as per schedule?
	13		Do the results meet the relevant acceptance criteria?
	14		Validation of Fo value of autoclave.
	E. Sample Receipt, Storage, and Documentation
	1		Is a specific person responsible for the receipt of samples for testing?
	2		Is there a written SOP describing sample receipt and recording (logging in)?
	3		Where are samples stored before and after testing?
	4		Are samples retained after completion of testing?
	5		What happens to samples after testing and reporting are complete?
	6		Are all test samples recorded in the laboratory logbook?
	7		Are all items clearly labelled?
	F. Test Procedures
	1		Are there approved test procedures available for all tests performed in the laboratory?
	2		Is there a written procedure for ensuring that all Pharmacopoeial procedures are updated when a supplemental monograph is issued?
	3		Examine the work currently being performed. Product Name : Batch No.: Test Procedure :
	4		Is it up-to-date?
	5		Is it being accurately followed?
	6		Has the test method been validated for precision and reliability?
	7		Are records available for the preparation of media used for performing the test?
	8		Is the medium labelled with an expiration date?
	9		Is labeling done in accordance with an approved SOP?
	10		Is the analysis recorded in the analyst’s Test Data Sheet (TDS) prior to beginning work?
	11		Has the analyst recorded all the relevant details of the product being tested, including the attachment of printouts or records of weighing?
	12		Is there a reference to the test method used in the analyst’s TDS?
	13		Are review sheets of Instrument Operating Procedure (IOP) /Equipment Operating Procedure (EOP) updated?
	14		Is there a written Microbial monitoring programme for non-sterile products?
	15		Does a procedure exist for media preparation?
	G. Recording Results
	1		Examine an analyst’s Test Data Sheet (TDS).
	2		Is it neatly filled in and legible?
	3		Are all calculations recorded?
	4		Are numbers rounded in accordance with an approved SOP?
	5		Is there a statement in the TDS as to whether or not the sample passes the test?
	6		Is the analyst’s signature recorded in the TDS?
	H. Stock Cultures
	1		Is there an SOP for the receipt and handling of American Typed Culture Collection (ATCC) / National Collection of Typed Culture (NCTC) cultures?
	2		Are cultures received with a certificate of analysis?
	3		How often are ATCC / NCTC cultures transferred?
	4		Identification of master cultures.
	I. OOS
	1		Is there an SOP for OOS handling
	2		Does the responsibilities are clearly mentioned in the SOP for the handling of the OOS?
	3		Does the SOP describe a procedure for invalidating results?
	4		Does the procedure require a written explanation of the reason for the retest?
	J. Environmental and Periodic Monitoring ( Clean Room )
	1		Is there an SOP for environmental monitoring in the clean room?
	2		Do results conform with the limit stated in the SOP?
	3		When out-of-limit results were obtained, was corrective action implemented in accordance with the SOP?
	4		Examine records of monitoring for the past three months.
	5		Are there records of checking laminar airflow velocities?
	6		Are there records of checking air changes?
	7		Check the trend charts of environment control (settle plate exposure and air sampling) in production areas.
	K. Methods Validation
	1		Have all in-house methods been validation?
	2		Is there a written SOP relating to the validation of microbiological methods?
	3		Does validation of methods provide data to demonstrate ¨       Method of Sensitivity ¨       Recovery of organism ¨        Effect of any inactivating anti microbial agent
	L. Water System
	1		Is there a written procedure which identifies the validation requirements of the water system?
	2		Was the system installed and validated according to written protocol prior to release to production?
	3		What are the tests done for the monitoring of the water system? Are results within limits?
	4		Check the updated schematic diagram of sampling points of potable/purified water.
	5		Are samples taken according to required frequency?
	6		Are all components of the systems are properly identified?
	7		Check the trend charts of seasonal variation for potable water.
	8		Check the trend charts of purified water IP.
	M. Other Document
	1		Are there updated schematic diagrams of location plan of settle plate exposure and air sampling in microbiology lab & production areas?
	2		Validation of cleaning / use of disinfectants in production areas.
	3		Validation of Microbiology testing area.
	4		Are the media stocks prepared in accordance to First In First Out (FIFO) rule?
	5		Identification of master cultures.
	6		Identification of environment control isolates & isolates of microbial limit test water analysis.
	7		Calibration of UV hour meter and intensity check of UV lights on LAF bench and Pass box.
	8		Fertility check of agar strips used for air sampling.

Self Inspection checklist for Quality Assurance

S.No.		Requirements		Compliance						Remarks
				Yes		No		N/A
	A. SOP
	1		Are a complete index and a complete set of applicable SOPs available in the department?
	2		Are the index and the SOP's current?
	B.  Personnel
	1		Are training records of the employees working in the department up-to-date?
	2		Have the employees undergone training in the following areas? ¨       GMP ¨       SOP's ¨       Quality Assurance Procedures
	3		Are all employees following the garmenting SOP, including, where necessary, masks, gloves, and beard covers?
	4		Is an up-to-date organizational chart of the Quality Assurance Department available?
	C. Batch Record Review
	1		Is there an SOP for batch record review prior to release?
	2		Is there a comprehensive checklist for batch record review prior to release?
	3		Examine recently released batch records. Product  :                           Batch No.: Product  :                           Batch No.: Product  :                           Batch No.:
	4		Are the records complete with respect to the following? ¨       The master formula is signed as true copy. ¨       Any changes to the master formula are QA authorized prior to manufacturing ¨       All relevant signatures are present. ¨       All relevant data are present. ¨       All relevant data are accurate. ¨       Yield calculation at each stage of production. ¨       All calculations are verified by a second individual.
	D. Change Control Records
	1		Are all changes that may impact product quality authorized by Quality Assurance prior to implementation?
	2		Examine recent change control records.
	3		Have the forms been completed and closed?
	4		Were any required tests performed and the results evaluated prior to closing the forms?
	5		Have all relevant documentation been updated? Verify that validation protocols have been revised where appropriate.
	E. Self-Inspection
	1		Is there an SOP that requires that self-inspection be performed in all departments?
	2		Is self-inspection performed according to the frequency stated in the SOP?
	3		Do all personnel required by the SOP to participate in inspections actually do so?
	4		Are written reports available for all inspections performed during the year?
	5		Is there written evidence of corrective action implemented as a result of the inspections?
	F. Complaints
	1		Is there an SOP for dealing with complaints?
	2		Examine recent complaints. Product  :                         Batch No.: Product  :                         Batch No.: Product  :                         Batch No.:
	3		Do the files contain all the relevant data?
	4		Have the files been signed by the relevant personnel?
	5		Could any of the above complaints affect other batches of the product and, if so, has an investigation been initiated and appropriate action taken?
	6		Examine the list of complaints for the year preceding the audit. Are there products that have several complaints and, if so, has appropriate corrective action been implemented?
	G. Rejected Batches
	1		Examine the list of rejected batches for the current year. Select three batches. Product  :                         Batch No.: Product  :                         Batch No.: Product  :                         Batch No.:
	2		List the reason (s) for the rejection.
	3		Specify at which stage of production the batches were rejected.
	4		Is there a written investigation, including conclusion as to the cause of the failure and, if appropriate, follow-up action for each of the batches?
	5		Are there any products that have more than one rejected batch and, if so, has corrective action been recommended and implemented?
	H. Recalls
	1		Is there a written procedure for the recall of drug products that ensures that responsible officials of the firm are notified in writing of the recall?
	2		Have there been any recalls during the current year?
	3		List the disposition of the recalled goods.
	4		Is the disposition adequately justified with a               documented investigation and conclusions authorized by Quality Assurance?
	5		Could the reason for the recall implicate other batches of the product and, if so, has an investigation been initiated and appropriate action taken?
	I. Validation
	1		Is there a written procedure for carrying out validation of drug products?
	2		Is Master Validation Plan available?
	3		Is it followed?
	4		Check the validation file of any one of the products being manufactured.
	J. Others
	1		Are there standard operating procedures for pest control?
	2		Is it followed?
	3		IS there standard operating procedure for qualification and Validations?
	4		Check whether it is followed.
	5		Is there standard operating procedure for training?
	6		Is it adhered to?

Annexure IV

SELF – INSPECTION- AUDIT SUMMARY

Date Of Audit		:			Location	:
Time Of Audit		:			Department	:
Auditor		:			Auditee	:
Sr. No.	Observation		1.      Critical 2.      Major 3.      Minor	Action Plan	Responsibility	TCD	Response received On	Closure Status	Remarks