Quality Audit plan and reports

Topic on Quality audit plan and reports full description ,planing for organisation to face audit.to gain a knowledge about what is quality audit and reports

1. Quality Audit Plan and Reports Presented By : Chetan G Mali FY M Pharm (Quality Assurance) Roll No: 10 College Name : Ravindra Gambhirrao Sapkal College Of Pharmacy, Nashik 1

2. INDEX Introduction Reasons of Quality Auditing Scope and Objectives Types of Audit Audit Planning Audit Report Protocol and reports 2

3. INTRODUCTION Defination:- Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. Quality audit means a systematic examination of a quality system. Quality audits are typically performed at defined intervals Any failure in their proper implementation may be published publicly and may lead to a revocation of quality certification 3

4. REASONS FOR QUALITY AUDITING: In order to internal: Determine the level of compliance Build confidence (hopefully) in GMP and the QA system Build interdepartmental trust, understanding, and communication (if the audit is done properly and tactfully) Determine measures necessary to improve Premises, equipment, environment Operations, actions, procedures Personnel/training Provide a stimulus for improvement Recommend corrective action 4

5. In order to external : Establish and monitor capability of supplier or contractor to deliver goods and services that are fit for purpose (and on time, and in the quantity required) Build mutual confidence Promote understanding and communication between the parties involved (both sides can learn!) And in general, as listed for “internal” 5

6. SCOPE AND OBJECTIVES 6

7. TYPES OF AUDIT 7

8. Internal Audit (First Party) : Increase the potential for early identification of regulatory concerns based on FDA interpretations and current compliance focus Identify compliance deficiency and deviations from industry standards and company requirements Provide a benchmark of compliance with other companies and regulatory expectations. Inform management about regulatory risk Foster continuous improvement and forward quality Provide a tool by which the company can stay ahead of rapidly increasing regulatory demands 8

9. Benefits Of Internal Audit : Tells you the health of a quality system Identify the root of a problem and plan for corrective and preventive actions with timeline Achieve better allocation of resources Able to avoid potentially big problem Continuous improvement 9

10. Implementing The Internal Audit System : Constitution of team Provide initial training Fix and audit schedule Carry out the audit Report the audit results Follow up 10

11. 2) External Audit (Second Party Or Third Party ): External audits are audits carried out by a company on its vendors or subcontractors. Furthermore, if work is contracted out, they must ensure that contractors are competent to complete it, in accordance with GMP. There are also strong business benefits to be derived from performing these audits: - building knowledge and confidence in the partnership arrangement ensuring that requirements are understood and met enabling reduction of certain activities ( eg. in-house QC testing of starting materials) reducing the risk of failure 11

12. Third Party : A customer wants an audit of your company but wants your company to pay for it. third-party audit occurs when a company has decided that they want to create a Quality Management System (QMS) that conforms to a standard set of requirements, such as ISO 9001 and hire an independent auditing company to perform an audit to verify that the company has succeeded in meeting these standards. 12

13. 3 ) Regulatory Audit : These audits are carried out by regulatory bodies against relevant regulations for the manufacture and supply of pharmaceutical products. National regulatory bodies, such as the Medicines Control Agency (MCA) in the UK and Food and Drug Administration (FDA) in the USA, are statutorily responsible for carrying out such audits. These audits may be unannounced (MCA currently performs about ten per cent of its UK inspections like this) as manufacturers are expected to be complying with GMP at all times. Regulatory bodies from other countries in which products are sold may also audit companies ( ie FDA audits European manufacturers). Regulatory inspectors are extensively trained and are Knowledable and Professionals 13

14. CONT: All MCA medicines inspectors are relevantly qualified and have a minimum of five years' appropriate experience in a manufacturing operation. Failure to pass a regulatory audit can lead practical experience of GMP and receive to restrictions on (or the withdrawal of) a manufacturing or import/export license. Regulatory audits vary considerably in scope, frequency and duration. Audits by the national regulatory body are likely to be regular and to cover systematically all areas of a facility, over a period of time. 14

15. 4 ) Product Audit: An in-depth examination of a particular product to evaluate whether it conforms to product specification, performance, standards, and customer requirements. 5) Process Audit : An analysis of elements of a process and appraisal of completeness, correctness of condition and probable effectiveness. 6) System Audit : A documented activity perform to verify, by examination and evalution of objective evidence, that applicable elements of the quality system are suitable and have been developed, documented and effectively implemented in accordance with GMP. 15

16. PROCESS OF AUDIT 16

17. AUDIT PLANNING BEFORE AUDIT DURING AUDIT AFTER AUDIT 17

18. BEFORE AUDIT Plan well in advance. Decide if there are any products or activities that you want to exclude from the audit. Get to know about your assessor. Even witness him auditing another site, if possible. Know your procedures and where they are located. Remove all absolute documentation. Ensure all uncontrolled documentation that you are working with are properly stamped “uncontrolled” Ensures all productive material, is identified by number and status. Ensure all materials are stored in authorized areas. Do not forget cover all shift patterns. 18

19. DURING AUDIT Be punctual and courteous. Make everyone aware that the auditors are likely to ask up to six questions: What is your quality policy? Tell me how do you do your job? Show me wherein your system it tells you to do this? Can I see some evidences? What action do you take if you have problems? What training have you received to help you to do this job? Be honest in your answers. Do not use terms like “usually "or “generally. They invite further questions. Do not fill in space between questions. If there is a gap, let the auditor fill it. Do not challenge or argue to excess. Make your point then stop. 19

20. AFTER AUDIT Do not argue at the exist meeting.it is too late. Do not rush into hasty corrective action.do it properly. Remain polite, even if you did not do well.it is not the auditor fault; it is your organization that failed. Shooting the messenger will not change a single thing!’ 20

21. AUDIT REPORTS 1)Title. The title used is “auditors report to the shareholders” 2)Address. The report is addressed to the company, it stakeholder or board of director. 3)Introductory. Indicating the date and the period covered in examining the financial statements by the auditor. 4)scope Paragraph. What the auditor did in the entire audit process. 5)opening Paragraph. States the Auditor’s conclusion/opinion on the results of audit examination. 6)auditor’s Name. 7)auditor’s Address. 8)Date Of The Report. 21

22. PROTOCOL AND REPORTS Defination :-A system of rules that explain the correct conduct and procedures to be followed in formal situations. The data collection protocol is the procedure for executing the above steps of the Plan to collect and record the data. It deals with management and administrative issues such as who does what and when. It also includes a plan for monitoring the data as they are collected to ensure quality. 22

23. References Pharmaceutical Dosage forms: Parenteral medication, Revised and Expanded. Edited by Kenneth E.Avis , Herbert A. libermann and Leon Lachmann , Volume -3, Second edition , Page no:-363-420 Pharmaceutical Quality group monograph no:-5 (revised): Pharmaceutical Auditing , IQA2001,ISBN 0906810 68X Audit Followed up. Retrieved on April 2010. By Electronic Version. http://www.auditnet.org/process.htm#ixzzOkHSIWg9 (2004) Internal Audit Polices and Procedures Chapter 14. Electronic Version. 23

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