Procedure for self inspection 1of 2

1.0	PURPOSE Self inspection is an independent review and evaluation of entire manufacturing operations which cover current Good manufacturing Practices (cGMP) adopted during manufacturing, testing and packaging operation of the plant. It also verifies the effectiveness of Quality Assurance program and its compliance with the regulatory affairs. This procedure will provide: 1.1  An overall view of the operational strengths and weaknesses of quality system. 1.2  An opportunity to study the defects in the system. 1.3  A chance to remove and maintain product quality.
2.0	SCOPE Self inspection serves the purpose of confirming to the top management of the company that various operations are being performed as per the guidelines issued. It also gives the indication that the defects pointed out and remedial steps suggested are completed in a time bound program.
3.0	RESPONSIBILITY Head –Respective Department
4.0	ACCOUNTABILITY Head –QA
5.0	PROCEDURE
5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.2 5.2.1 5.3 5.3.1 5.3.2 5.3.3 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.5 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.6 5.6.1 5.6.2 5.6.3	Preparation of Self Inspection Schedule:  Head QA / Designee in consultation with all departments shall prepare Yearly audit schedule as per     annexure–I .Self inspection year will be continue from January to December. This schedule shall be sent to the concerned department head / designee and the identified auditors for their information and course of action. The schedule shall be prepared to cover all the functional departments twice in a year. Carry out of the self inspection within the±3 days from the schedule date and ensure the availability of auditor and auditee. The availability of auditor that participate in Self inspection shall be confirmed as per annexure II. Self Inspection Team: Self inspection team will consist of Production Incharge, Quality Assurance Head, Quality Control Head and Incharge Utilities or any other Person authorized by the Quality Assurance Head. Correspondence: Head QA (Location) shall circulate the yearly self-inspection schedule in the month of December. Scheduled inspection shall be reminded at least 5 days in advance. All correspondence shall be through mail. Conducting The Audit:  5.4.1     The audit for following needs to be conducted: ·         Personnel ·         Premises including personnel facilities ·         Maintenance of building and equipment ·         Storage of raw material, Packaging material and finished products ·         Equipments ·         Utilities ·         Production and in-process controls ·         Quality Control ·         Quality System ·         Documentation and Data control ·         Sanitation and hygiene ·         Calibration of instruments or measurement system ·         Results of previous self – inspections and any corrective steps taken ·         Label control ·         Medical checkup ·         Organogram ·         Recall procedure & complaint management.  ·         Qualification, validation and revalidation programme. The auditors and auditiee shall mutually discuss and fix up the date of the audit in the scheduled date or appropriate date within time frame. The audit will commence with reference of cGMP norms, SOP’s, procedure work, instruction, Previous audit reports etc. The auditor shall deeply examine the implementation and compliance of the cGMP norms, last audit report, SOP’s, established system and procedures for any type of deviations and recommendation. Self – inspection will be done as per checklist (Annexure No.III). Based on the findings, Auditor shall make a report in the Annexure-IV comprising of audit observation, recommendation for improvement and action plan for the findings. The action plan (compliance for audit observation) shall be given by Auditee and agreed action plan shall be recorded in the Annexure IV. The observations are classified as Critical, Major and minor based on the impact of the observation on quality, safety, purity of the products and GMP. The general guideline to be followed to classify is as given below: Critical: Which directly affects the quality, safety and purity of product and not complying with GMP                     practice. Corrective action to be taken immediately.                     Major: Which indirectly affects the quality, safety and purity of product and not complying with GMP                practice. Corrective action to be taken immediately.  Minor: Defects, which can be noted and corrected at scheduled program. Auditee shall provide the tentative completion date with name of the designated responsible person for ensuring that the agreed action plan is complied upon within the TCD based on the category of observation. The dully-signed copy of the report shall be submitted to QA department for information and record. QA department in turn shall provide a copy of the report to both the departments. Compliance of Audit Report:    The auditee shall ensure that the compliance of agreed corrective action and preventive measures on or before the agreed date as mentioned in the audit report. The head QA/ designee shall verify the compliance of the agreed action plan with corrective and preventive action on or after the last tentative completion date mentioned in the report (Except for the exceptionally lengthy TCD’s). In case of deviation from the TCD QA Head shall discuss thoroughly with the auditee and grant permission for the revised TCD. When action could not be completed due to unforeseen event or unavoidable circumstances, proper justification shall be provided and in case the deviation in TCD is due to negligible / Lack of knowledge or any other reason preventive action shall be provided to avoid the recurrence. QA Head/ Designee shall discuss thoroughly with auditee and grant permission for the revised TCD. In any case, however the next due date (TCD) shall be arrived at by studying all factors which led to delay and revised TCD will be strictly followed through QA and Auditee will together complete the action and close the NCR. Send the completed audit report to Head QA for his records after closing. Final summary of Audit Report:   After completion of the audit of all departments, Head QA or his designee shall verify all the audit points and their corrective action on critical non-conformance. The summarized version of audit report shall be discussed by Head QA in Management Review Meetings. Alternately a brief report may be sent to Head- Corporate Quality Assurance.. Head QA ensures the implementation of decisions taken in the management review meeting in relation to audit points. Frequency: Self inspection shall be conducted at least twice a year.
6.0	REFERENCES  cGMP Guideline    SOP guideline by  D.H. Shah

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	SELF INSPECTION SCHEDULE	QA/017/F01-02
Annexure II	DEATILS OF SELF INSPECTION TEAM	QA/017/F02-03
Annexure III	SELF INSPECTION CHECKLIST	QA/017/F03-00
Annexure IV	SELF – INSPECTION- AUDIT SUMMARY	QA/017/F04-03

8.0	ABBREVIATIONS

Abbreviations				Full Forms
SOP				Standard Operating Procedure
cGMP				Current Good Manufacturing Practice
TCD				Target Completion Date
NCR				Non Conformance Report
9.0	DISTRIBUTION
Master Copy					Head Quality Assurance Department
Controlled office Copy No. 1					Quality Assurance Deptt.
10.0	REVISION HISTORY
S.No.	Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

Annexure I

SELF INSPECTION SCHEDULE

Department

Jan

Feb

Mar

Apr

May

June

July

Aug

Sep

Oct

Nov

Dec

PRODUCTION DEPARTMENT

LIQUID

QUALTIY CONTROL

QUALITY ASSURANCE

TABLET (Compression, Granulation & Coating)

PACKING  & STORE

EXTERNAL DEPARTMENT

LOTION & STORE

SOAP

Annexure II

DEATILS OF SELF INSPECTION TEAM

DATE OF AUDIT:

Sr. No.	NAME	DEPARTMENT	DESIGNATION	SIGN & DATE

Annexure III

Self Inspection checklist for Warehouse

Sr. No.	Requirements	Compliance			Remarks
		Yes	No	N/A
A. SOP
1	Is a complete index and a complete set of applicable SOPs available in the department?
2	Are the index and the SOP's current?
3	Are the of SOP’s available at the respective places?
B.  Personnel
1	Are their 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 ·      Warehouse / Weighing techniques
3	Are all employees following the garmenting SOP, including, where necessary, masks, gloves, and beard covers?
C.  Facilities
1	Is access to the department restricted to authorized personnel only?
2	Are materials stored in separate areas according to status?
3	Are different materials and different batches of the same material stored on separate pallets to prevent mix-ups?
4	Is the department maintained in a good state of repair?
5	Is the department neat and orderly with sufficient space for equipment and operations?
6	Where appropriate, are all work areas clearly labelled with the name and the batch number of the product being processed?
7	Is there adequate physical separation between different operations to prevent mix-ups and / or Cross Contamination?
8	Is there an SOP describing precautions to be taken when weighing highly sensitive drugs, including cleaning procedures after weighing?
9	Is there an SOP for monitoring the temperature and the relative humidity in the department?
10	Is there documented evidence that it is followed?
D.  Cleaning
1	Are there written procedures for cleaning the warehouse and dispensing room?
2	Is there documented evidence that the cleaning procedures are being followed?
3	Is there a written procedure for cleaning the dispensing room. ¨       Between batches of the same product? ¨       Between batches of different products?
E.  General
1	Is there a valid calibration status affixed to equipment?
2	Is there an SOP describing the receipt of components and the Examination to be done? Is the examination documented?
3	Where a shipment contains more than one batch, is each batch tested and released separately?
4	In the event that containers are damaged, does the SOP specify the corrective action to be taken? Is there documented evidence that the SOP is followed?
5	Are containers of raw materials cleaned externally on receipt? Is cleaning in accordance with a written SOP?
6	Can materials be located easily within the warehouse according to the assigned location?
7	Are all items in the warehouse labelled as to their status?
8	Have all items designated released been tested and, if necessary, retested according to an approved SOP?
9	Is there a separate area for the storage of rejected materials?
10	Is stock rotated according to the FIFO rule?
11	Where the FIFO rule is deviated from? Is there written justification of the deviation?
12	Is access to the printed packing material area restricted to authorized personnel?
13	Are all printed packaging materials stored in a restricted access area?
14	Are packaging materials of different product, strengths, dosage form, or quantity of contents stored separately?
15	Is all instrumentation in the department labelled with a valid calibration tag?
16	Is there an SOP for checking the accuracy of the balance used for dispensing of packaging material?
17	Examine records of these checks. ¨       Are they performed according to the frequency shown in the SOP? ¨       Where necessary, has appropriate corrective action been implemented?
18	Is there an SOP for checking the accuracy of the machine used for dispensing material?
19	Examine records of these checks. ¨       Are they performed according to the frequency shown in   the SOP? Where necessary, has appropriate corrective action been implemented?
20	Is there an SOP describing the dispensing of printed packaging materials?
21	Is there an SOP for dispensing additional packaging materials if the quantity initially dispensed to production was not sufficient?
22	Is there an SOP for the return of printed packaging materials to the warehouse? ¨       Is it followed? ¨       Is the return recorded?
24	Are finished goods awaiting release stored in a separate area from raw materials?
25	Is there an SOP for the distribution of finished goods after release?
26	Examine the distribution records for products. Are the goods distributed according to FIFO?
F.  Sampling
1	Is there an SOP describing sampling operations, including a sampling plan?
2	Examine the status board of the sampling room. Is the material currently being sampled recorded on it? Is the airflow system operational? Is the sampler appropriately gowned? Are the containers that are to be sampled clean of external dust and powder?
3	Select one of the raw materials currently under quarantine. Is the material recorded as having been sampled?
4	Is sampling equipments are stored in a manner to prevent its contamination?
G.  Weighing
1	Are all instruments in the department labelled with a valid calibration tags?
2	Is there an SOP requiring the inspection of the area for cleanliness prior to and at the end of dispensing operations?
3	Is the operation documented on the status board?
4	Examine the record of the daily check of balances in the department. ¨       Is it complete and accurately filled out? ¨       Are all results within the specifications? ¨       If not, is there a record of the implementation of       corrective action? ¨       Perform a visual examination of the weights used       for the check. ¨       Are they in a good state of repair? ¨       Do they bear a valid calibration tag?
5	Is there an SOP describing the receipt of raw materials for weighing operations?
6	Are all the materials required for one weighing operation assembled together in a defined area?
7	Is there an SOP describing weighing operations? Does it require verification of vendor tare weights?
8	Check a weighing operation being performed. ¨       Is all documentation filled in up to the ingredient being weighed? ¨       Is the weigher appropriately attired? ¨       Is all equipment used clean at the start of the operation?
9	Examine the staging area for weighed batches. Are all the ingredients for one batch assembled together?
H.  Others
1	How the stock checks inspections is done?
2	How the consumable stocks are maintained?
3	Are the spares parts inventory for the equipments in the area are maintained?
4	Check the inventory management system?
5	Is there an SOP describing the management of the inventories?

Self Inspection checklist Production

Sr.No	Requirements	Compliance					Remark
		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?
3	Are the of SOP’s available at the respective places?
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 ¨       Production techniques
3	Are all employees following the garmenting SOP, including, where necessary, masks, gloves, and beard covers?
C.  Facilities
1	Is the department maintained in a good state of repair?
2	Is the department neat and orderly with sufficient space for equipment and operations?
3	Are all the raw materials for one batch assembled on a pallet?
4	Where more than one pallet is designated for one batch, is each pallet clearly labelled?
5	Are all work areas clearly labelled with the name and the batch number of the product being processed?
D.  Prevention of Cross-Contamination
1	Are doors closed at all times?
2	Is a personnel clothing clean, unstained, and dust free, including foot wares?
3	Is pressure differential is maintained in working areas at all times during work?
4	Is there a record of the pressure differential?
5	Is dirty equipment covered prior to transfer to the washing room?
E.  Equipment and Facility Cleaning
1	Are pallets and drums brought into the area clean are free from powder /dust.
2	Is the equipment neat, clean, and rust free?
3	When not in use, are equipment covered so as to prevent accidental contamination?
4	Are the equipment constructed so that product contact surfaces are not reactive or absorptive, so that it will not contaminate or in any way affect the product being manufactured?
5	Are there specific procedures for the cleaning of major equipment items?
6	Select a major piece of equipment. Examine the following records: ¨       Machine history file ¨       Status Board
7	Visually inspect one piece of equipment that is not in use. Is it labelled with respect to its cleanliness status? Is it clean?
9	Do cleaning procedures include a requirement for the cleaning of accessories? (e.g., Scoops, ladles etc.)?
10	Is there documented evidence that it is being followed?
11	Is there a written procedure for washing the finger bags of fluid bed dryers?
12	Where compressed air is supplied to machinery, is it oil free and filtered?
13	Is there an SOP for filter replacement?
14	What filtration is provided to incoming air in fluid bed dryers?
15	Is there an SOP for the cleaning and replacement of these filters?
16	What measures are taken to prevent cross-contamination of product from these filters when inlet air is not functioning?
F.  Working Procedures
1	Examine the record of the daily check of balances in the department.
2	Is it complete and accurately filled out?
3	Are all results within the specifications?
4	If not, is there a record of the implementation of corrective action?
5	Perform a visual examination of the weights with which the check is performed. Are they in a good state of repair? Do they bear a valid calibration sticker?
6	Examine the batch record for a batch that is being processed. Product:  Batch No.:
9	Is the record completely and accurately filled out up to the appropriate stage of processing?
10	Are all in-process results within the defined limits?
11	Is there a written procedure for the cleaning of drums after use?
12	Examine the in-process storage area.
13	Are the inprocess material properly labelled?
14	Is there an SOP defining the maximum period of time that inprocess material may be stored prior to final pack?
15	Examine a sample of in process material to be sent to the laboratory for testing.
16	Is it labelled in accordance with the relevant SOP?
17	Do yield calculations conform to the relevant SOP?
18	If not, has a BMR been completed and an investigation conducted?
19	Is there a record of checking the sieve screens before use for signs of damage?
20	Is there an SOP for the receipt of punches and dies in the department?
21	Are punches lubricated in the department and, if so, with an approved lubricant?
22	Is there an approved SOP for in-process control?
23	Does the SOP state at what frequency tests must be performed by Production personnel?
24	Examine a batch record. Is the test frequency adhered to?
25	Do all test results conform to specifications?
G.  Equipment Calibration
1	Is there an approved annual program for the Calibration of all production equipment?
2	Select three equipment items and examine the Calibration records.
3	Are the equipment items identified with a distinguishing code number?
4	Is all critical instrumentation on the equipment items identified with a valid calibration tag?
5	Physically verify that all instruments found on the equipment   items are included in the Calibration file.

Self Inspection checklist for Engineering

Sr. 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?
3		Are the of SOP’s available at the respective places?
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 ¨       Engineering techniques
3		Are all employees following the garmenting SOP, including, where necessary, masks, gloves, and beard covers?
C. Calibration Records
1		Are there written procedures which describes calibration process?
2		Is there an approved annual calibration schedule?
3		Is there a tracking procedure in place to ensure that every instrument included in the program actually undergoes calibration on time?
4		Is the master list of instruments and calibration procedures available in the area? Are they maintained and updated?
5		How is new equipment entered into the calibration system?
6		Are there written SOPs describing in detail how to perform calibrations?
7		Examine the calibration history of critical instruments.
8		Is there written evidence that the calibration standard used were within calibration?
9		What procedure is followed if the results of the calibrations do not comply with the limits?
10		How the damaged or faulty test instrument is handled?
11		How the external calibration contractor approved?
D. Preventive Maintenance Records
1		Is there an approved annual preventive maintenance program?
2		Are there written procedures for preventive maintenance for all utility equipment?
3		Are there written records of performance?
4		Examine the preventive maintenance history of equipments?
5		Is there written evidence for each machine that the preventive maintenance was performed in accordance with the relevant SOP?
6		Is the master list available which identifies that all equipments are included?
7		Are the maintenance manuals, drawings, wiring diagrams and parts list of equipments under preventive maintenance program?
8		Are all documents properly signed and dated?
E. Breakdown Maintenance Records
1		Is there a record of breakdown maintenance for each piece of production equipment?
F. Equipment Qualification
1		Is there an approved program for the qualification of equipments?
2		Examine the IQ/OQ protocols.
3		Physically verify that all instruments found on the equipment are included in the protocols.
4		Cross-check with the calibration records that the equipment items have the same classification the qualification protocol as in the calibration report.
5		Are the qualification reports approved by all appropriate personnel?
6		Are the reports completely and accurately filled out?
G. Drawings
1		Is there a complete set of approved drawings for systems and equipment available in the department?
2		Check equipment items/systems and examine the available drawings.
3		Are the drawings the latest edition?
4		Is the drawing QA approved?
H. Alarms Procedures
1		Is there a well defined alarming system available? Specify the use.
2		Is there an SOP for responding to alarms for critical systems?
3		Is there procedure followed?
I. Filter Integrity Test Records
1		Is there an SOP for performing HEPA filter integrity tests?
2		Is the procedure adhered to?
3		Examine records of the most recent tests performed.
4		Is it found in order?
J. Airflow Velocity Test Records
1		Is there an SOP for performing the test?
2		Is the procedure adhered to?
3		Examine records of the most recent tests performed.
4		Is it found in order?
K. Air Changes Test Records
1		Is there an SOP for performing the test?
2		Is the procedure adhered to?
3		Examine records of the most recent tests performed.
4		Is it found in order?
L.		AHU Cleaning Record
1		Is there an SOP for cleaning procedure for AHU?
2		Examine records of the most recent cleaning activity performed.
M		Water System
	A. SOPs
	1		Is a complete index and a complete set of applicable SOPs available to The system operator?
	B. Personnel
	1		Has the system operator undergone training in ¨       GMP? ¨       SOPs?
	2		Are the training records up-to-date?
	C. Walk-Through of System
	1		Perform a walk-through inspection of the entire system.
	2		Is the general environment clean and tidy for ¨       Potable water storage? ¨       The purified water production system? ¨       The purified water storage system?
	3		Is the system leak free, rust free, and well maintained?
	4		Are system controls such as electrical panels and switches protected so as to prevent accidental tampering?
	5		Is access to the main water holding tank for the factory restricted?
	6		Are the covers to the main water holding tank locked?
	7		When was the main water holding tank last cleaned / sanitized?
	8		Is this recorded and is it in accordance with the relevant SOP?
	9		When the purified water production system was last sanitized?
	10		Was it in conformance with the relevant SOP?
			Are user points well maintained, with flexible tubing stored in such a way as to minimize contamination?
	D. System Drawings
	1		Is a complete set of up-to-date system drawings available to ¨       The system operator? ¨       Maintenance personnel?
	2		Compare the drawings with those in the most recent validation file. Are they the same?
	3		Have any changes been authorized by Quality Assurance?
	4		Has a change control form been completed?
	5		If any changes have been made, has the validation file been updated and any necessary testing performed?
	6		Did the results meet the specifications?
	E. System Operating Records
	1		Examine the daily records for the water system for two months preceding the audit.
	2		Have they been completed on a daily basis?
	3		If any faults or breakdowns in the system were noted, was an unusual events. Report form completed and distributed to concerned personnel?
	F. System Maintenance Records
	1		Examine records of performance of preventive maintenance. Do they include the following? ¨       Cleaning and sanitation of the main water holding tank ¨       Cleaning and sanitation of the purified water production system ¨       Cleaning and sanitation of the purified water storage system
	G. System Validation File
	1		Examine the validation file for the purified water system
	2		Was the validation performed according to schedule?
	3		Does the report indicate that the system is operating in a repeatable and reliable manner?
	4		Have any non conformity's with the validation protocol been indicated in the report, explained, and suitably authorized?

Self Inspection checklist for Quality Control

Sr. No.	Requirements	Compliance				Remarks
		Yes	No		N/A
A. SOPs
1	Is a complete index and a complete set of applicable SOP, STP, STS available in the department?
B. Personnel
1	Are the training records of the employees working in the department up-to-date?
2	Have the employees undergone training as per                               GLP Analytical techniques
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	Are prepared solutions labelled according to respective SOP.?
D.  Instrumentation and Calibration
1	Is there an approved preventive maintenance program for all equipment / instruments used in the laboratory?
2	Is there evidence that it is followed?
3	Is the program based on manufacturer’s recommendations?
4	If not, is there a documented rationale for the alteration of the schedule?
5	Is there documented evidence that the person who performs the preventive maintenance is qualified to do so?
6	Are there written procedures for operating the instruments?
7	Are there written procedures for calibrating the instruments?
8	Is there a valid calibration sticker on each instrument?
9	Examine the calibration records for the instruments. ¨       Are they up-to-date? ¨       Are the results within limits?
10	Is there an SOP for corrective action in the event that an instrument is found to be out of calibration?
11	Where standards are used to calibrate an instrument, is there a written procedure for their preparation?
12	Where ever applicable, the instruments are calibrated to the traceable standards?
13	Does the schedule includes all the relevant software used in Q.C.
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 and reporting? If not, What happens to samples after testing and reporting are complete?
6	Is there a time limit on how long a sample may remain in the laboratory prior to testing?
7	Are the reserve samples kept as per procedure?
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 pharmacopoeia procedures are updated when a supplemental monograph is issued?
3	Examine the work currently being performed on the HPLCs. Product Name  : Batch No. :
4	Is it up-to-date?
5	Is it being accurately followed?
6	Has the test method been validated for precision and reliability?
7	Is the analysis recorded in the analyst’s notebook prior to beginning work, including the physical appearance of the sample?
8	Has the analyst recorded all the relevant details of the product being tested, including the attachment of printouts or record of weighing?
9	Is there documented evidence that system suitability was determined prior to use of the chromatography in the analysis?
10	Is there a reference to the test method used in the analyst’s Test Data Sheet (TDS)?
11	Do retention samples form part of laboratory records.
12	Is written cleaning procedure available for all equipment and glassware?
13	Are laboratory records having name of Product and Batch number?
14	Are laboratory records indicating date of receipt of sample and expiry date?
G. Recording Results
1	Examine an analyst’s Test Data Sheet.
2	Is it neatly filled in and legible?
3	Are any cross-outs initialled and dated?
4	Is there an SOP for TDS maintenance?
5	Is there a record of the instrument used for testing together with any raw data?
6	Are all calculations recorded?
7	Are all charts, graphs, and printouts labelled with the ¨       Product name and batch number? ¨       Date of the test?
8	Are numbers rounded in accordance with an approved SOP?
9	Do the dates on graphs/charts match with the dates of analysis?
10	Is there a statement in the TDS as to whether or not the sample passes the test?
11	Is the analyst’s signature recorded in the TDS?
12	Are references of Instruments/Equipment's and volumetric solution used given in the TDS.
H. Reference Standards / Working Standards
1	Examine a reference standard.
2	Is it stored appropriately?
3	Is document available for receipts of same?
4	Is the standard tested internally to confirm its quality?
5	Is there a written SOP for the preparation of working standards?
6	How often are working standards prepared?
7	What expiration date is given to working standards?
8	Has the expiration date been validated?
9	Are working standards certified against compendia standards?
10	Is there a record of the preparation of volumetric solutions?
11	Are volumetric solutions freshly prepared?
12	If stored, what expiration date are they given?
13	Examine a test where a volumetric solution was used. Was the titre correctly recorded in the notebook?
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.  Evaluation of Results
1	Is there an SOP for review of test data and calculations?
2	Are raw data reviewed prior to release from the laboratory by a person other than the analyst who performed the test?
3	Are TDS routinely reviewed by a supervisor?
4	Do reviewers sign the TDS to indicate that it has been reviewed?
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?

M