The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.

1. GMP COMPLIANCE AUDIT
Presented by :
Megha G. Bhise
Department of Regulatory affairs
Parul Institute of Pharmacy, Parul University,
Vadodara

2. CONTENT
Introduction
Goals of GMP audit
GMP Audit Services
GMP audit Process
Parts of GMP Audit
Classification of GMP Compliances
Benefit GMP audit Compliances
GMP Audit checklist.

3. INTRODUCTION
A comprehensive GMP audit provides a How well your organization is complying
with GMP regulations, and it also shows in fine detail where your company needs to
improve.
A GMP audit is a comprehensive, third-party inspection of a production company. It
is meant to identify operational flaws and legal violations.
A GMP audit is a process by which an external or internal individual or team verifies
that a manufacturer is following its documented Good Manufacturing Practices

4. Cont…
The Quality systems approach in GMP includes following systems:
1) Production
2) Materials
3) Facilities and Equipment
4) Packaging/labeling
5) Laboratory Controls

5. GOALS OF GMP AUDIT
GMP audits with important goals:
1) Audis are intended to verify that manufacturing and Control systems are operating
under a state of control.
2) Audits permit timely correction of potential problems.
3) Audits can be used to establish a high degree of confidence to remain under an adequate
level of control by managements

6. GMP AUDIT SERVICES
There are two audit services to ensuring GMP compliance:
A. Onsite GMP audit
An on-site GMP audit is by far the best way to check if a company is GMP compliant and
ready for an official regulatory audit.
An on-site audit involves the following:
• Pre-audit discussion to determine the audit scope and plan.
• Audit preparation which includes a review of some documents from SOP, SMF, previous
regulatory audit reports – deficiencies noted and responses provided.
• Performance of the audit and discussion of audit findings as well as coaching/training any of
staff involved in the audit.
• Compiling a report of audit.

7. Cont..
B. Desktop GMP Audits:
The Desktop Audit format was developed by the Australian TGA.
This format is now used by other international regulatory authorities and is a more budget-
friendly audit that doesn’t involve sending consultants on-site.
A desktop GMP audit involves:
• Company sending key documents e.g. Validation master plan, batch release records, etc. to
the assigned auditor on our side.
• The auditor reviewing the documents for compliance.
• The auditor will then call you for clarification if required .
• Once all the issues have been discussed, then auditor will compile a final report.

8. GMP AUDIT PROCESS
Plans Opening
Meeting
Collects facts
and Evidence
Documents
Relevant
Information
Prepares A
Written Report

9. PARTS OF GMP AUDIT
GMP Audit consists of following parts, covering:
1. Personnel: The checklist covers a supplier's procedures for reporting employee illnesses,
employee dress codes, handling procedures, training methods, and supervision policies.
2. Plant and Grounds: Auditors assess building functionality, surrounding lot cleanliness
storage units, glass and light bulb protection, and proper ventilation.
3. Sanitary Operations: Facility and equipment cleaning, toxic substance storage
practices, single-use paper disposal procedures, and pest control effectiveness.
4. Sanitary Facilities and Controls: Consistent use of potable water; water temperature
and pressure appropriate for manufacturing use; adequate plumbing and floor drainage
systems.

10. Cont…
5. Equipment and Utensils: Equipment made from non-toxic, corrosion-resistant material;
surfaces and contours designed to prevent the accumulation of microorganism growth.
6. Processes and Controls :Quality control checks on all raw materials and : work areas
for microorganisms; cross-contamination.
7. Warehousing and Distribution: Proper storage procedures, records of previously
shipped loads by individual containers, stock rotation, proper safety labeling.
8. Defect Action Levels: Procedures put in place to immediately address product defaults.

11. CLASSIFICATION OF GMP COMPLIANCE
1. NAI-(No Action Indication)
2. VAI - (Voluntary Actions Indicated)
3. OAI - (Official FDAAction Indicated)
1) NAI (No Action Indication):
No objectionable conditionsor - practices (e.g., violations of 21 CFR Parts 50, 54, 56, 312,
511, and 812) were found during the inspection, or the significance of the documented
objectionable conditions found does not justify further FDA action. No objectionable
conditions or practices were found by the FDA.

12. Cont…
2. VAI (Voluntary Actions Indicated) :
Objectionable conditions - were found and documented, but the Center is not
prepared to take or recommend any further regulatory (advisory or administrative)
action because the objectionable conditions do not meet the threshold for regulatory
action.
A VAI classification should be made only if a FDA-483 has been issued.
3. OAI (Official FDAAction Indicated):
 If objectionable conditions were found, one of the actions listed below should be
recommended.
a) Subjects under the care of the investigator would be or have been exposed to an
unreasonable and significant risk of illness or injury
b) Subjects' rights would be or have been seriously compromised.
c) Data integrity or reliability is or has been compromised.

13. BENEFITS OF GMP COMPLIANCE
Gain greater knowledge of the quality issues affecting the organization
Develop increased awareness of regulatory expectations
Recognize commonly seen GMP deficiencies and learn how to reduce them in
your organization
Understand the inspection process and how you can prepare for it.
Identify quality-critical areas in your own organization e.g. technical agreements,
training, record keeping, delegation
Receive guidance on changing legislation and increasing complexity in the
manufacturing and distribution chain for medicinal products.

14. AUDIT CHECKLIST FOR THE DRUG
INDUSTRY
Sanitation and Hygiene.
Validation and Revalidation Program.
Calibration of Instruments or measurement systems.
Recall Procedures.
Complaints management.
Labels Control.
Result of Previous Self-Inspection and corrective step taken.

15. REFERENCES
1. https://www.pharmout.net/services/gmp-consulting-services/gmp-compliance-
audits/
2. https://www.qima.com/gmp-food-audits-and-compliance/gmp-audit
3. https://www.thefdagroup.com/blog/gmp-audits
4. Cutting, Thomas (January 12, 2008). "How to Survive an Audit". PM Hut.
http://www.pmhut.com/how-to-survive-anaudit. Retrieved December 13, 2009.
5. Patel KT, Chotai NP. Vendor qualification for pharmaceutical excipients–GMP
requirements and approach. Die Pharmazie-An international Journal of
Pharmaceutical Sciences. 2010 Nov 1;65(11):783-90.