Audit-Ready Processes in the Pharmaceutical Industry: A Brief Review
DOI:
https://doi.org/10.37285/ijpsn.2024.17.1.6Abstract
An audit-ready process in the pharmaceutical industry refers to a systematic approach implemented by pharmaceutical companies to ensure compliance with regulatory requirements and industry standards. It involves establishing and maintaining procedures, controls, and documentation that enable efficient and effective audits by regulatory authorities, external auditors, or internal audit teams. This study begins by providing an overview of the regulatory landscape in the pharmaceutical sector, highlighting the key regulations and guidelines that govern the industry. It explores the evolving expectations of regulatory authorities, emphasizing the need for pharmaceutical companies to maintain rigorous compliance and transparency throughout their operations. This study develops into the concept of an audit-ready process, defining its key components and characteristics. It examines the benefits of such processes, including improved risk management, enhanced operational efficiency, and increased stakeholder confidence. The study also explores the challenges associated with implementing audit-ready processes, such as resource allocation, training, and cultural shifts within organizations. This study analyzes various methodologies and frameworks that can be utilized to establish audit-ready processes in the pharmaceutical industry. It explores the principles of quality management systems, risk-based approaches, and data integrity frameworks, highlighting their relevance and applicability in ensuring audit compliance and readiness.
Downloads
Metrics
Keywords:
Audit-ready process, Regulatory requirements, Auditors, Quality management systems, Data integrity frameworks
Published
How to Cite
Issue
Section
References
Kannan, S., Morais, S. R., Prema, S., & Chitra, K.. Auditing as A Management Tool in Pharmaceutical Companies. International Journal of Pharmacy and Biological Sciences.2020; 10(1): 230-233.
Uddin, M. S., Al Mamun, A., Rashid, M., & Asaduzzaman, M. In-process and finished products quality control tests for pharmaceutical capsules according to pharmacopeias. Journal of Pharmaceutical Research International.2016; 1-9.
Ghose, Aditya, & Koliadis, G.. Auditing business process compliance. In International Conference on Service-Oriented Computing.2007; 1-9.
Karapetrovic, S., & Willborn, W. Generic audit of management systems: fundamentals. Managerial Auditing Journal.2000;15(6), 279-294.
Karapetrovic, S., Willborn, W., & Pickett, K. Quality assurance and effectiveness of audit systems. International Journal of Quality & Reliability Management.2000; 17(9), 959-970.
Arter, D. R.Quality audits for improved performance. Quality Press. 2003(pp.14-45)
Pickett, K. H. The internal auditing handbook. John Wiley and Sons. 2010.8:200.
Pickett, K. H. Spencer. The Internal Auditing Handbook. 2012(pp.1-19,311-393)
Kumar S, Tanwar D, Arora N. The role of regulatory GMP audit in pharmaceutical companies. International Journal of Research and Development in Pharmacy & Life Sciences 2013; 2:493-8.
Karen G, Gil B. Compliance Auditing for Pharmaceutical Manufacturers. New York: Inter pharm; 1994; 4-11.
Nikita N. Patel1, Parag R. Patel, Falguni A. Tandel, Karuna J. Patel, Ujjaval N. Limbachiya1, Charmy S. Kothari. World Journal of Pharmacy and Pharmaceutical Sciences. 2012; Volume 1, Issue 4, 1228-1249.
Alili Idrizi, E., Ahmeti Lika, S., Bexheti, D., Dauti, M., Janevik Ivanovska, E. Quality Audits - Viewpoints of Auditing in the Pharmaceutical Industry. 2022 AJMHS, Vol 60 (pp.40-89).
Kumar, R., & Sharma, V.Auditing: Principles and practice. PHI Learning Pvt Ltd. 2015;(pp.24-48).
Busch, R. S. Healthcare fraud: Auditing and detection guide. John Wiley and Sons. 2012; Vol 1(pp.12-32).
Nyholm, J.R. Persistency, bioaccumulation, and toxicity assessment of selected brominates flame retardants. Environmental Toxicology and Chemistry; 2009; 28, 1035-1042.
Anderson, K. Intelligence-Based Threat Assessments for Information Networks and Infrastructures. Global Technology Research, Inc. 1999; 11- 45.
Kaur, J.Quality audit: Introduction, types, and procedure. Pharma Pathway.2017;Vol-2(pp.12-27)
Choudhary, A., & Bake, A.Internal audit or self-inspection defects and regulatory compliance checklist. Pharmaceutical guidelines.2013;(pp-23-78)
Shah, M.Quality audit: A tool for continuous improvement and compliance.2018; 1-5.
Choudhary, A., & Bake, A. Internal audit or self-inspection defects and regulatory compliance checklist. Pharmaceutical guidelines. 2013; 2-27.
Shabrina Tri Asti Nasution, Iskandar Muda. Internal Audit Quality in Pharmaceutical Companies; Journal of Pharmaceutical Negative Results.2022; 10468–10473.
Tsim, Y. C., Yeung, V. W. S., & Leung, E. T. C. An adaptation to ISO 9001:2000 for certified organizations. Management Audit Journal.2002; 17(5), 245–250.
Lerche, I., & Glaesser, W. Environmental risk assessment. In quantitative measures, anthropogenic influences are human impact. Birkhäuser 2006; 2-10.
Congressional Research Service. A Review of risk assessment methodologies for the Subcommittee on Science, Research, and Technology. 1983; 3-7.
Lachin, J. M. Biostatistical methods: the assessment of relative risks. John Wiley & Sons. 2009; 8-33.
Bernacchi, T. The Pharmacy Audit: What Is It and Are You Prepared? Journal of Managed Care Pharmacy.1999; 5, 93-98.
Kumar, S., Tanwar, D., & Arora, N..The role of regulatory GMP audit in pharmaceutical companies. International Journal of Research and Development in Pharmacy and Life Sciences. 2013; 2, 493-498.
National Research Council. Science and judgment in risk assessment. National Academies Press.1994; 2-9.
Linna, A., Korhonen, M., Mannermaa, J.-P., Airaksinen, M., & Juppo, A. M.. Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturers. European Journal of Pharmaceutics and Biopharmaceutics.2008; 69(2), 786-792.
Lieberman, D. Using a Practical Threat Modeling Quantitative Approach for data security.2009;(pp.2-5).
Goh, T.N., & Xie, M.Improving on the Six Sigma paradigm.TQM Magazine.2004; 16(4), 235-240.
Aksoy, T., & Bozkus, S.. Establishment of Effective Internal Audit Function: Recommendations for Best Practice. Journal of Modern Accounting and Auditing.2012; 8(9), 1283-1290.
Bota-Avram, C., Pop, A., & Bota-Avram, F. The future perspectives of the internal audit function. Annales Universitatis Apulensis Series Oeconomica.2009; 1(11), 19.
Mitra, A. Six Sigma education: a critical role for academia. TQM Magazine.2004; 16(4), 293-302.
Vedanabhatla, S., & Gupta, N. V. A review on audits and compliance management. Asian Journal of Pharmaceutical and Clinical Research.2013; 6, 43-45.
McAdam, R., & Evans, A. Challenges to Six Sigma in a high technology mass manufacturing environments. Total Quality Management, 2004; 15(6), 699-706.
ISO/FDIS 9001.Quality management systems-requirements. Geneva: International Standards Organization.2000; 3-45.
Narayana, Sushmita & Pati, Rupesh & Vrat, Prem. Research on management issues in the pharmaceutical industry: A literature review. International Journal of Pharmaceutical and Healthcare Marketing. 2012; 6-14.
Hung YC, Huang SM, Lin QP, ‐Tsai ML. Critical factors in adopting a knowledge management system for the pharmaceutical industry. Industrial Management & data systems. 2005 Feb 1;105(2):164-83.
Dubey N, Gupta H, Sharma RK, Dubey N, Dubey N. Pharmaceutical quality management system: Current concept. Journal of Advanced Pharmacy Education & Research. 2011; 2:120-4.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).Q9 Quality Risk Management. Geneva: ICH.2005 ;( pp.2-28).
Chowdary BV, George D. Improvement of manufacturing operations at a pharmaceutical company: a lean manufacturing approach. Journal of Manufacturing Technology Management. 2012; 23(1):56-75.
Narayana SA, Pati RK, Vrat P. Research on management issues in the pharmaceutical industry: a literature review. International Journal of Pharmaceutical and Healthcare Marketing. 2012 Nov 23;6(4):351-75.
Martin, A. Auditing a QC microbiology laboratory. In M. R. Saghee, T. Sandle, & E. C. Tidswell, Microbiology and sterility assurance in pharmaceuticals and medical devices. New Delhi: Business Horizons.2011;(pp. 237-258)
J. S. Snell, D. F. J. Brown, & C. Roberts .Sharp, I. R.Quality audit and quality system review in the laboratory. J, Quality assurance: Principles and practice in the microbiology laboratory. Colindale: Public Health Laboratory Service.1999 ;(pp.6-18).
Kundu S, Paul D, Patra R and Ray J .Systematic Study about the Audit of Medical Device, International Journal of Research in Pharmaceutical Sciences.2023;14(2), pp. 79-87.
Sandle, T., & Saghee, M. R.Auditing clean rooms. In M. R. Saghee & T. Sandle (Eds.), Cleanroom management in pharmaceuticals and healthcare. UK: Euromed, Passfield.2012; pp. 551-566.
Sutton, S. Qualification of a contract microbiology laboratory. J Validation Technol.2010; 16(4), 52-59.
Haleem RM, Salem MY, Fatahallah FA, Abdelfattah LE. Quality in the pharmaceutical industry-A literature review. Saudi pharmaceutical journal. 2015;Oct 1;23(5):463-9.
Kaur, G., Khanna, S. and Nasa, A. Six Sigma in Pharmaceutical regulatory affairs. Presented at 59th Indian pharmacy congress, Varanasi India.2007; pp-2-8.
Agarwal, Princy & Mishra, Amul. Pharmaceutical quality audits: A review. International Journal of Applied Pharmaceutics. 2019; 11-14.
Merrill, R. A. Food safety regulation: reforming the Delaney Clause. Annual Review of Public Health.1997;18(1), 313-340.
Hannon, Megan The Challenges of Remote Auditing Faced by the Pharmaceutical Industry.2020;Vol. 15;(pp.9-17).
Taleb, N. N.The fourth quadrant: a map of the limits of statistics. An Edge original essay, Edge.2008;(pp.9-22).
Leonard, Steinborn. International Organization for Standardization ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories. 2004; 383-415.
Badr, I. Applying Total Quality Management in Pharmaceutical Industry. 2022; 98-106.
Agarwal PR, Mishra AM. Pharmaceutical quality audits a review. International Journal Applied Pharm. 2019; (pp.11:14-22).
Kamble, P., & Kumar, A. International Journal of Research Publications In Engineering And Technology.2016; 2(12), 4-6.
Manuselis, G., Rausch, M., & Wilson, P. Quality assurance in clinical microbiology. Clinical Lab Sci.1989; 2, 34-36.
