INTERNAL AUDIT: A CRUCIAL OBJECTIVE TO ACHIEVE cGMP

ABOUT AUTHORS:
MR. Gunjegaonkar S.M., MR. Shelke T.T.
Assistance Professor.
Dept. of Pharmacology JSPM’s Charak College of Pharmacy and research,
Wagholi, Pune. Maharashtra.
*gunjeshiv@gmail.com

Internal audit is designed programme to seek any short comings in quality assurance systems and to suggest corrective action. It also monitors implementation and compliance with current good manufacturing practices.

A.OBJECTIVES:
1. Ensure that companies operations remain compliance with and implements cGMP.
2. Assist in ensuring continuous quality improvement.
3. Cover all corrective aspects in production and quality control.

REFERENCE ID: PHARMATUTOR-ART-1860

SPECIAL OCCASIONS MAY DEMAND ADDITIONAL INTERNAL AUDIT:
e.g. Recalls
Repeated rejections
Inspection announced by National Drug Regulatory Authority Authorization

B.SELECTION OF INTERNAL AUDITORS:
i. HODs from Production ,Q.C ,Q.A , and Engineering with good working experience, communication skill and awareness regarding ISO.
ii. The evaluation should be impartial.
iii. Frequency may depend upon company requirements and size of company.

C. AUDIT PLANNING:

Sr No.	SEQUENCE OF PROCESS	OWNER	PROCESS OUTPUT
1	Prepare an audit plan		Annual audit plan
2	According to importance of the functions to be audited, prepare and release department wise ”Audit Schedule”, describing the Date, Dept. to be audited, auditee, applicable clauses/ process, timings and auditors. The audit schedule shall cover all clauses and all Dept each time. Release the audit schedule at least 03 days prior to audit.		Audit Schedule
3	While scheduling, ensure that auditor should not have the direct responsibility of the area to be audited		Audit Schedule
4	Provide “Audit Schedule” and blank copies of “Audit Report” and “Non conformity report” to auditor.		Audit Report

	Prepared By	Verified By	Authorized By
Signature:
Date:
Name:	Ahire K.R.	Dosi B.P.	Dosi B.P.
Designation:	QA Chemist	QA Manager	QAManager

OBJECTIVE:
To Provide Documented Procedure for review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements.

SCOPES:
To define role/responsibility of various functions responsible for internal audit

RESPONSIBILITY:
1. Board of Internal Audit and Management Review Committee: Arranges for the internal audit and gathers all information for the Management Review.
2. QA Management Committee: Provides all information as required by the Board of Internal Audit and Management Review Committee and is responsible for follow-up corrective and preventive actions.
3. QA Internal Auditor(s): Conduct the internal audit according to GMP.

PURPOSE:
This document describes the conduct of the Management review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements of ISO Guide and is effectively implemented.

PROCEDURE:
1. The QA Management Committee, by consensus, selects three qualified individuals for the Board of Internal Audit and Management Review Committee. Members to the Committee serve until they are replaced.
2. The Board of Internal Audit and Management Review Committee arranges for the annual internal audit to be conducted.
3. The date for the audit is established by mutual agreement between the Board of Internal Audit and Management Review Committee and the General Manager Production and Asst. Manager Production (AMP).
4. The audit is conducted by any member of the board or Internal auditor qualified to participate on the Certification Board so long as the auditor is not a member of the QA Management Committee, is qualified and knowledgeable in certification, auditing.
5. The audit must be conducted at least every 12 months.
6. During the audit, personnel responsible for the area audited are immediately notified of the outcome of the audit of their area.
7. During an audit, it is possible that a difference of opinion can arise as to the severity of an observation. It is important not to spend too much time debating the merits of the observation. If it does not appear that the difference of opinion can be resolved, then the auditee should be
8. Results of internal and external audits
9. Feedback from clients and interested parties related to the fulfillment of the Certification Process
10. Feedback concerning impartiality
11. Follow-up actions from previous Certification Program Management Review Reports
12. The status of corrective or preventive actions
13. The fulfillment of objectives
14. Changes that could affect the management system
15. Appeals and complaints
16. The Board of Internal Audit and Management Review Committee submit their Certification Program Management Review Report to the QA Management Committee.
17. The Certification Program Management Review Report with the response to the internal audit is discussed at the next meeting of the full Board. The expected output of the review includes decisions and actions related to:
18. Improvement of the effectiveness of the management system and its processes.
19. Resource needs.
20. Decisions and actions of the Board are documented in the Board Minutes and all open Corrective/Preventive Actions are reviewed and their status documented at all subsequent quarterly Board Meetings.
21. Effectiveness of completed actions is reviewed at the next Program Management Review.

REFERENCE:

In-House

ABBREVIATIONS:

Nil

INTERNAL AUDIT CHECK LIST

INTERNAL AUDIT CHECK LIST FOR QC DEPARTMENT

Sr. No.	Check points	Observation (yes/no)	Comments	Recommendation	Action taken by
1	Is the control copy of QC department SOPs available?
2	Are the personnel having knowledge of current GMP requirements?
3	Is the housekeeping maintained?
4	Is the weighting balance having proper tag of calibration status?
5	Is the balance calibration record available?
6	Are the calibrated standard weights available?
7	Is the calibration certificate available?
8	Is the standard weights are properly stored?
9	Are the status labels available on each instrument?
10	Is the instrument calibration record available?
11	Check the temperature and humidity record.
12	Check the cleaning record.
13	Check the cleaning of sampling devices.
14	Are all the sampling devices properly stored?
15	Lab and storage areas uncluttered (i.e. aisles and exits free from obstructions).

INTERNAL AUDIT CHECK LIST FOR PRODUCTION DEPARTMENT

Sr. No.	Check points	Observation (Yes/No)	Comments	Recommendation	Action taken by
1	Is the control copy of production department SOPs available?
2	Are the personnel having knowledge of current GMP requirements?
3	Are the lots of raw material properly stored?
4	Are the lots of raw material having proper labels of status?
5	Is the housekeeping maintained?
6	Is the weighting balance having proper tag of calibration status?
7	Is the balance calibration record available?
8	Are the calibrated standard weights available?
9	Is the calibration certificate available?
10	Is the standard weights are properly stored?
11	Is the reactor area cleaned?
12	Is the status label of reactor available?
13	Is the BMR requisition slip record available?
14	Check the calibration status of temperature gauges.
15	Check the calibration status of pressure gauges.
16	Check the status of centrifuge.
17	Check the cleaning of centrifuge and centrifuging area.
18	Check the condition of centrifuge bags.
19	Check the status of dryer.
20	Check the cleaning of dryer and drying area.
21	Check the calibration status of temp, Gauge of dryer.
22	Check the trays and trolley condition.
23	Check the status of sifter.
24	Check the cleaning of sifting area.
25	Check the status of multi mill.
26	Check the cleaning of milling area.
27	Check the finished product packing area.
28	Check the availability and stock of packing materials.
29	Check the temperature and humidity record.
30	Check the cleaning of sampling devices.
31	Are all the sampling devices properly stored?
32	Check the general cleaning and housekeeping of plant.
33	Check the test request slip record.
34	Check the personnel hygiene.
35	Check the safety equipments.
36	Check the other records.
37	Is ECR available?
38	Check the ECR.
39	Check the condition of reactors.
40	Are there work instruction labeled on all equipments.
41	Are records maintained for Solvent Receipt, Usage & Recovery In Plant?
42	Check the records of Solvent Receipt, Usage & Recovery In Plant.
43	Is there any training record for new employee?
44	Check the training record and training schedule.
45	Is the pipeline properly marked with directional arrows?
46	Is logbook of all Equipment properly maintained?

INTERNAL AUDIT CHECK LIST FOR MAINTENANCE DEPARTMENT

Sr. No.	Check points	Observation (Yes/No)	Comments	Recommendation	Action taken by
1	Is the control copy of Maintenance department SOPs available?
2	Is the personnel having knowledge of current GMP requirements?
3	Is the preventive maintenance schedule available?
4	Check the preventive maintenance records.
5	Are equipments labeled with last maintenance date and next due maintenance date?
6	Are the equipment qualifications available?
7	Check the equipment qualification record.
8	Is the temperature gauges calibration record available?
09	Check the temperature gauges calibration record.
10	Are the pressure / vacuum gauge calibration record available?
11	Check the calibration record.
12	Check the break down maintenance record.
13	Check the DM water generation record.
14	Check the AHU maintenance record.
15	Check the AHU’s filter cleaning record.
16	Check the AHU’s differential pressure record.
17	Is there any training schedule for new entrant in maintenance department?
18	Are new entrant trained after join maintenance department?
19	Are there any documents for postponement of the schedule maintenance?
20	Is the department follow the postponement of the schedule maintenance and send it to review by QA department?
21	Is there check list for each equipment for preventive maintenance?
22	Check the equipment check list.
23	Are all electrical motor labeled and well maintained?
24	Check the status of the electrical motor.
25	Check the maintenance status of DG Set.
26	Is the maintenance store area clean?
27	Check the housekeeping of maintenance store area.
28	Are all storage tanks properly labeled?

INTERNAL AUDIT CHECK LIST FOR STORE

Sr. No.	Check points	Observation (Yes/No)	Comments	Recommendation	Action taken by
1	Is the control copy of store department SOPs available?
2	Is the personnel having knowledge of current GMP requirements?
3	Is the incoming raw materials entry register available?
4	Is the housekeeping maintained?
5	Is the sampling booth area cleaned?
6	Is the weighting balance having proper tag of calibration status?
7	Is the balance calibration record available?
8	Are the calibrated standard weights available?
9	Is the calibration certificate available?
10	Is the standard weights are properly stored?
11	Is the quarantine, approved and rejected area designated?
12	Are the UNDER TEST label pasted on all the incoming raw materials?
13	Are the SAMPLE label pasted on all the sampled raw materials?
14	Are the APPROVED labels pasted on all the approved raw materials?
15	Are the raw materials stored at their respective place?
16	Check the cleaning and housekeeping condition record of quarantine, approved and rejected area.
17	Are the packing materials stored separately?
18	Is the cleaning and housekeeping maintained at packing material store area?
19	Is the temperature and relative humidity record maintained for all respective area?
20	Is the approved vendor list available?
21	Is the FIFO system follow?
22	Check the production requisition slip record?
23	Check the issuance record?
24	Check the dispatch record?
25	Check the general cleaning and housekeeping of store?
26	Check the personnel hygiene?
27	Check the safety equipments?
28	Check the drum storage yard for cleaning, housekeeping and status?
29	Check the proper segregation at drum storage yard?
30	Check the other records?

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INTERNAL AUDIT: A CRUCIAL OBJECTIVE TO ACHIEVE cGMP

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