GMP compliances of Audit

Presentation comprising all the GMP compliances of Audit

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: Production Materials Facilities and Equipment Packaging/labeling Laboratory Controls

5. GOALS OF GMP AUDIT GMP audits with important goals: Audis are intended to verify that manufacturing and Control systems are operating under a state of control. Audits permit timely correction of potential problems. 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: 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.. 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

9. PARTS OF GMP AUDIT GMP Audit consists of following parts, covering: Personnel: The checklist covers a supplier's procedures for reporting employee illnesses, employee dress codes, handling procedures, training methods, and supervision policies. Plant and Grounds : Auditors assess building functionality, surrounding lot cleanliness storage units, glass and light bulb protection, and proper ventilation. Sanitary Operations: Facility and equipment cleaning, toxic substance storage practices, single-use paper disposal procedures, and pest control effectiveness. 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 … Equipment and Utensils: Equipment made from non-toxic, corrosion-resistant material; surfaces and contours designed to prevent the accumulation of microorganism growth . Processes and Controls : Quality control checks on all raw materials and : work areas for microorganisms; cross-contamination . Warehousing and Distribution : Proper storage procedures, records of previously shipped loads by individual containers, stock rotation, proper safety labeling. Defect Action Levels: Procedures put in place to immediately address product defaults.

11. CLASSIFICATION OF GMP COMPLIANCE NAI-(No Action Indication) VAI - (Voluntary Actions Indicated) OAI - (Official FDA Action Indicated) 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 FDA Action 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 https://www.pharmout.net/services/gmp-consulting-services/gmp-compliance-audits/ https://www.qima.com/gmp-food-audits-and-compliance/gmp-audit https://www.thefdagroup.com/blog/gmp-audits Cutting, Thomas (January 12, 2008). "How to Survive an Audit". PM Hut. http://www.pmhut.com/how-to-survive-anaudit. Retrieved December 13, 2009. 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.