PHARMACEUTICAL QUALITY AUDITS: A REVIEW

  • Princy Agarwal M.Pharma Research Scholar, Department of Pharmaceutical Quality Assurance, Bhupal Noble’s Institute of Pharmaceutical Sciences, Bhupal Noble’s University, Sevashram Road, Udaipur-313001, Rajasthan, India
  • Amul Mishra Associate Professor, Department of Pharmaceutics, Bhupal Noble’s Institute of Pharmaceutical Sciences, Bhupal Noble’s University, Sevashram Road, Udaipur-313001, Rajasthan, India

Abstract

Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. It is one of the means to examine pharmacy programs and ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose. These audits can be extended to suppliers and contractors as well. An audit will assess the strengths and weaknesses of quality assurance and quality assurance processes, the results of which assists in improving processes and building a better system for company benefits. This article focuses on various aspects of quality auditing in the pharmaceutical industry including its principles, objectives, importance and benefits and planning along with the deficiencies that are likely to occur during the process. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.
Keywords: Quality audit, Auditor, Audit planning, Internal audit, Audit procedures, Audit deficiencies

References

1. Kumar S, Tanwar D, Arora N. The role of regulatory GMP audit in pharmaceutical companies. Int J Res Dev Pharm Life Sci 2013;2:493-8.
2. Kaur J. Quality audit: Introduction, types and procedure [Internet]. Place Unknown: Pharma Pathway; 2017. Available from: http://pharmapathway.com/quality-audit-introduction-types-and-procedure/. [Last accessed 19 Mar 2018]
3. Biswas P. ISO 9001. Internal audit [Internet]. Place Unknown: Word Press; 2015. Available from: http://isoconsultantpune.com/iso-90012015-internal-audit-by-pretesh-biswas-apb-consultant/. [Last accessed on 19 Mar 2018]
4. Bernacchi T. The pharmacy audit: what is it and are you prepared? J Managed Care Pharm 1999;5:94-8.
5. Shah M. Quality audit: a tool for continuous improvement and compliance. Place unknown: Pharma Tips. Available from: http://www.pharmatips.in/Articles/Quality-Audit-A-Tool-For-Continuous-Improvement-And-Compliance.aspx. [Last accessed on 19 Mar 2018]
6. Professional Development Committee, the Institute of Cost Accountants of India. Exposure Draft: Guidance Note on Internal Audit of Pharmaceutical Industry; 2013. Available from: http://icmai.in/upload/Institute/Comments_Invited/ED-IA-Pharma.pdf. [Last accessed 19 Mar 2018]
7. Vedanabhlata S, Gupta VN. A review on audits and compliance management. Asian J Pharm Clin Res 2013;6:43-5.
8. Sharma S, Kohli S, Potdar M. Current good manufacturing practices: Audit. Place Unknown: Word Press; 2008. Available from: https://drpotdar.wordpress.com/2008/04/30/audit/. [Last accessed 19 Mar 2018]
9. Active Pharmaceutical Ingredients Committee (APIC). Auditing guide; 2016. Available from: http://apic.cefic.org/pub/Auditing/APIC_CEFIC_AuditingGuideAugust2016.pdf. [Last accessed 19 Mar 2018]
10. BSI standards publication: European committee for standardization. Guidelines for auditing management systems; 2011. Available from: http://qic-eg.com/wp-content/uploads/2015/08/BS-EN-ISO-19011-2011.pdf. [Last accessed 19 Mar 2018]
11. Chartered Institute of Internal Auditors. How to gather and evaluate information; 2017. Available from: https://www.iia.org.uk/resources/delivering-internal-audit/how-to-gather-and-evaluate-information/?downloadPdf=true
12. Performance Review Institute. Internal auditor techniques: Data gathering [Internet]. Place Unknown: Performance Review Institute; Available from https://docs.google.com/ viewerng/viewer?url=https://visionpdf.com/download/1-internal-auditor-techniques-data-gathering-performance-rev.html?reader%3D1. [Last accessed 19 Mar 2018]
13. Association of Accountancy Bodies in West Africa (ABWA): Accounting Technicians Scheme (West Africa). Principles of auditing. ABWA Publishers. Second edition; c2009. p. 101-10. Available from: http://www.icanig.org/documents/ ATSWA_ PRINCIPLES_OF_AUDITING.pdf. [Last accessed 19 Mar 2018]
14. Kaplan Financial Knowledge Bank. The audit planning process. UK: Kaplan Financial; c2012. Available from: http://kfknowledgebank.kaplan.co.uk/KFKB/Wiki%20Pages/The%20Audit%20Planning%20Process.Aspx. [Last accessed 19 Mar 2018]
15. Roger CPA Review Blog. The 10 steps in planning an audit; 2009. Available from: https://www.rogercpareview.com/ blog/10-steps-planning-audit. [Last accessed 19 Mar 2018]
16. Choudhary A, Bake A. Internal audit or self-inspection defects and regulatory compliance checklist. Place Unknown: Pharmaceutical guidelines; 2013. Available from: https:// www.pharmaguideline.com/2013/05/pharmaceutical-self-inspection-defects.html [Last accessed 19 Mar 2018]
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How to Cite
Agarwal, P., & Mishra, A. (2019). PHARMACEUTICAL QUALITY AUDITS: A REVIEW. International Journal of Applied Pharmaceutics, 11(1), 14-22. https://doi.org/10.22159/ijap.2019v11i1.29709
Section
Review Article(s)