The Role of Regulatory GMP Audit in Pharmaceutical Companies.

The Role of Regulatory GMP Audit in Pharmaceutical Companies.

• 1.
  THE ROLE OFREGULATORY GMP AUDIT IN PHARMACEUTICAL COMPANIES Presented By :- Guided By:- Jitendra K. Sonawane Dr.L.R.Zawar M.Pharm (QA) H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur
• 2.
  Contents ▪ Introduction. ▪ Componentsof audit ▪ Objectives of Auditing ▪ Importance of Audit in Pharmaceutical Industry ▪ Purpose of FDAAudits ▪ Standard Operating Procedures for Auditing ▪ Compliance classifications. ▪ Types of auditor. ▪ Auditing procedure ▪ References
• 3.
  INTRODUCTION ➢ Auditing isa critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. ➢ The general definition of an audit is an evaluation of a person, organization, system, process, enterprise, project or product. ➢ Internal Audit Standard Board (ICAB) defines auditing is the independent examination of financial information of any entity, whether profit oriented or not, and irrespective of its size or legal form, Internal auditing is fundamental to any quality improvement initiative.
• 4.
  ➢ In particular,the FDA cGMP’s for pharmaceutical products require that an organization conduct internal quality audit to determine the effectiveness of its quality system. ➢ Auditors are typical part of the Quality Assurance (QA) or Regulatory Compliance function for examine the data trail to determine whether company policies and procedures are followed.
• 5.
  Components of audit 1.Risk Assessment 2. Scope Statement 3. Audit Program 4. Audit Procedures 5. Workpapers 1. Risk Assessment:- Identifies relevant risk factors that challenge an organizational area and further considers their relative significance.
• 6.
  2. Scope Statement:- Identifiesthe activities that will be covered during the course of the audit. This includes the project justification, the project description, the deliverables, and the success criteria. 3. Audit Program:- Is the document that contains the listing of audit procedures as well as the objectives of the audit. 4. Audit Procedures :- Are the specific tasks that the auditor follows to gather, analyze, and document during the audit. 5. Workpapers :- Are the detailed documentation from interviews and testing that conducted to complete the audit program.
• 7.
  Objectives of Auditing 1.To determine the conformity or non-conformity of the quality system in meeting the specified requirements. 2. To determine the effectiveness of the implemented quality in meeting the specified Quality objectives. 3. To provide the Audit team with an opportunity to improve the Quality system. 4. To meet the regulatory requirement 5. To permit listing of the audited organizations Quality systems in a register.
• 8.
  Audits are generallyinitiated for one or more of the following reasons: 1. To initially evaluate the supplier where there is a desire to establish a contractual relationship. 2. To verify that an organization own quality system continues to meet specified requirements and is being implemented. 3. Within a framework a contractual relationship to verify the suppliers quality system continues to meet specified requirements and is being implemented. 4. To evaluate an organization’s own quality system against quality system standard.
• 9.
  Importance of Auditin Pharmaceutical Industry: Auditing has become one of the important key for the success of a pharmaceutical company. Regulatory agencies play a very important role in the pharmaceutical companies by assuring the good quality so that safe and effective product should be delivered to the public. 1. Pharmaceutical manufacturers commonly use audits as effective mechanism to verify compliance with GMPs. 2. Audits are intended to verify that manufacturing control systems are operating under the state of control. 3. Audit can detect potential problems to permit timely correction.
• 10.
  4. To assessthe effectiveness of these QA systems and to ensure it follow GMP, self inspection and other regulatory audits must be performed. 5. To ensure the quality, all pharmaceutical manufacturers are required to establish and implement as effectivepharmaceutical QA system. 6. Audits can be used to establish with a high range of confidence to remain adequate level of control by Management 7. Medicinal products have to be of high quality as people lives depend on it, although end product testing of samples from each batch is important, it is not enough to ensure quality which must be built in to the manufacturing processes.
• 11.
  Purpose of FDAAudits Thepurpose of the Audits conducted by the Regulatory Authorities such as FDA is: 1. To determine that the rights, safety and welfare of subjects have been protected 2. To assess adherence to FDA regulations and statutory requirements 3. To determine the quality and integrity of data submitted in support of healthcare products registration pending FDA approval. 4. To ensure that the facility is in compliance with FDA rules and regulations. 5. To know that product development was done appropriately and the cGMP are up to FDA standards.
• 12.
  Standard Operating Proceduresfor Auditing A pharmaceutical company has to prepare a standard operating procedure for auditing which includes the following points: ✓ 1. Information regarding the company policy pertaining to auditing. ✓ 2. Composition of the auditing team with clarity on their authority and responsibility ✓ 3. Statement of purpose scope of audits ✓ 4. Chosen areas subjected to auditing ✓ 5. Frequency of auditing ✓ 6. Written reports on audits including their distribution ✓ 7. Corrective action to be taken as a result of deficiencies uncovered during the auditing including time-tables and provision for reaudits when appropriate.
• 13.
  Compliance classifications: 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
• 14.
  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, administrative, or judicial) 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.
• 15.
  Types of auditor A.First-Party Audit: B. Second-Party Audit C. Third-Party Audit 1. First-Party Audit: This type of audit also known as internal audit or self-audit those auditing and those being audited all belong to the same organization. (Ex. Q.A Department). 2. Second-Party Audit: A second-party audit refers to a customer conducting an audit on a supplier or contractor. (EX. QSR, ISO 9001 or ISO 13485 standards.) 3. Third-Party Audit: Neither customer nor supplier conducts this type of audit. A regulatory agency or an independent body performs a third-party audit for the purpose of compliance or certification or registration. (EX. FDA investigator conducting a cGMP inspection at a pharmaceutical company.
• 16.
  Auditing procedure There aretotal 10 steps of the audit process: 1. Notification 2. Planning 3. Opening meeting 4. Field work 5. Communication 6. Draft audit 7. Management response 8. Final meeting 9. Report distribution 10.Feedback
• 18.
  References 1. Cutting, Thomas(January 12, 2008). "How to Survive an Audit". PM Hut. http://www.pmhut.com/how-to-survive-anaudit. Retrieved December 13, 2009. 2. http://en.wikipedia.org/wiki/Audit" 3.http://ezinearticles.com/?10-Steps-to-Maximize-Your- Energy- Audit&id=3633861 4."http://en.wikipedia.org/wiki/Management_representationn" 5. Nyholm, J, 2009 "Persistency, bioaccumulation and toxicity assessment of selected brominated flame retardants" 6. Anderson, K. "Intelligence-Based Threat Assessments for Information Networks and Infrastructures: A White Paper",2005.
• 19.
  Thank You