Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

Hazard Analysis and Critical Control Points as a QRM tool

  • , Priya School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India
  • Meenu Chaudhary School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India


For several years, quality risk management (QRM) has been such an integral component of healthcare as well as pharmaceutical product manufacturing. Effectual QRM can help companies make better informed and smarter choices, and furnish regulators with more prominent confirmation of an organization's capacity to manage possible dangers. In the pharmaceutical sector, the Hazard Analysis and Critical Control Points (HACCP), a QRM tool is comparatively a new approach. It is a globally perceived management system that gives rules to the pharmaceutical and food industries. HACCP approach emphasizes the hazards, with the overarching goal of ensuring that drug products are safe to use because the production of drug products is prone to health together with safety concerns. The HACCP system offers guidance to a considerable extent for quality control, by detecting, assessing, monitoring, and validating the crucial procedures and operations in the manufacturing of pharmaceutical products. The presented review article provides HACCP as a risk assessment tool, which could be applied to various parts of drug quality so that it might promote and assist the adoption of quality practices by pharmaceutical industries with the objective of improving HACCP efficiency together with company performance.

Keywords:  HACCP, Hazards, QRM, Quality

Keywords: HACCP, Hazards, QRM, Quality


Download data is not yet available.

Author Biographies

, Priya, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India

School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India

Meenu Chaudhary, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India

School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India


1. Sivadasu S, Gangadharappa HV, Quality risk management: a review, International Journal of Pharmaceutical Sciences Review and Research, 2017; 44(1):142-148
2. Reddy VV, Quality risk management in pharmaceutical industry:a review, International Journal of Pharmtech Research, 2014; 6(3):908-914
3. Lotlikar MV, Quality risk management (qrm): a review, Journal of Drug Delivery & Therapeutics, 2013; 3(2):149-154 https://doi.org/10.22270/jddt.v3i2.447
4. Pharmaceutical CGMPS for the 21st century - A risk-based approach, FDA, 2004
5. Pharmaceutical quality system, ICH Harmonized Tripartite GuidelineQ10, 2008
6. Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). Draft Consensus Guideline Q11, 2011
7. Risk Management: Guidelines and Best Practices Missouri Information Technology Advisory Board Project Management Committee Risk Management Subcommittee, 2003.
8. Risk Management - Vocabulary - Guidelines for Use in Standards, International organization for Standardization, 2002
9. Nauman M, Bano R, Implementation of quality risk management (qrm) in pharmaceutical manufacturing industry, IOSR Journal of Pharmacy and Biological Sciences, 2014; 9(1):95-101 https://doi.org/10.9790/3008-091495101
10. Shelar SS, Quality risk management (qrm) in pharmaceutical industry: tools and methodology, International Journal Of Innovative Research In Technology, 2020; 7(1):811-816
11. WHO Guideline On Quality Risk Management Working document QAS/10.376/Rev.2 August 2012
12. Guidance for Industry: Quality Risk Management Version 1.0 Drug Office Department of Health Guidance. Available at: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guidance%20for%20industry_QRM_201312.pdf
13. Venkatesh MP, Nagendra SR, Pramod KTM, Opportunities and challenges in the implementation of ICH Q9 with emphasis to a WHO approved pharmaceutical plant, International Journal of Research in Pharmacy and Science, 2017; 7(2):15-22
14. Sharma A, Jeyaprakash MR, Bora R, Chandra A, Impact of quality risk management process in pharmaceutical industry to curtail the non-conformity, International Journal of Pharmaceutical Quality Assurance, 2020; 11(1):179-185. https://doi.org/10.25258/ijpqa.11.1.28
15. WHO Technical Report Series No 908, 2003 Annex.7
16. World Health Organization, Quality Assurance of Pharmaceuticals, A Compendium of Guidelines and Related Materials, Volume 2. Geneva, 2004.
17. Jain, S. Quality by design (QBD): a comprehensive understanding of implementation and challenges in pharmaceuticals development", International Journal of Pharmacy and Pharmaceutical Sciences, 2014; 6(1):29-35.
18. Bauman, H, HACCP: Concept, development, and application, Food Technology, 1990; 44(5):156-158.
19. Mortimore, S. and Wallace, C. HACCP: A Practical Approach, 2" Ed. Aspen Publishers, Gaithersburg, MD. 2000
20. Wagh DG, Shahi SR, Magar DR, Ingle TB, Khadbadi SS, Gugulkar R, Karva GS, Quality by design in product development: A review, Indo Journal of Pharmaceutical Research, 2015; 5:1667-80
21. O'Neill, Peter, Sohal, Amrik, Teng, Wei C ,Quality management approaches and their impact on firms ׳ financial performance-An Australian study, International Journal of Production Economics, 2016; 171: 381-393. https://doi.org/10.1016/j.ijpe.2015.07.015
22. Cormier RJ, Mallet M, Chiasson S, Magnu'sson H, Valdimarsson G Effectiveness and performance of HACCP-based programs, Food Control, 2007; 18(6): 665-671. https://doi.org/10.1016/j.foodcont.2006.02.019
23. Wallace CA, Holyoak L, Powell SC, Dykes FC, Re-thinking the HACCP team: An investigation into HACCP team knowledge and decision-making for successful HACCP development, Food Research International, 2012; 47(2):236-245. https://doi.org/10.1016/j.foodres.2011.06.033
24. Ross-Nazzal, J, From Farm To Fork: How Space Food Standards Impacted The Food Industry And Changed Food Safety Standards. In S. J. Dick and R. D. Launius (Eds.) Societal Impact of Spaceflight, Washington, DC: NASA, 2007; 219-236
25. Sandrou K, Arvanitoyannis S, Application of hazard analysis critical control point (haccp) system to the cheese-making industry: a review, Food Reviews International, 2000; 16(3):327-368 https://doi.org/10.1081/FRI-100100291
26. National Research Council (US) Subcommittee on Microbiological Criteria. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients, Washington (DC): National Academies Press (US), 1985
27. Anon. Recommendations of the US National Advisory Committee on Microbiological Criteria for Foods: I HACCP principles, II meat and poultry, III seafood, Food Control, 1991; 2(4):202-211 https://doi.org/10.1016/0956-7135(91)90188-3
28. Woodcock J, The concept of pharmaceutical quality. American Pharmaceutical Review, 2004, 7(60):10-15
29. Mayes T, HACCP training. Food Control, 1994; 5(3):190-5. https://doi.org/10.1016/0956-7135(94)90082-5
30. Mortimore S, Wallace C, HACCP: A Practical Approach, 2"Ed. Aspen Publishers, Gaithersburg, MD, 2000.
31. Ababouch, L, The role of government agencies in assessing HACCP. Food Control, 2000; 21(2):137-142. https://doi.org/10.1016/S0956-7135(99)00071-7
32. Cusato S , Tavolaro P, Oliveira CAF, Implementation of Hazard Analysis and Critical Control Points System in the Food Industry:Impact on Safety and the Environment, 2019
33. Umi R, Norazmir, M.N. A systematic review on hazard analysis and critical control points (haccp) in southeast asia countries, Indian Journal of Public Health Research & Development, 2021; 12(2):420-425
34. Quinn BP, Marriott NG, HACCP plan development and assessment: a review, Journal of Muscle Foods , 2002; 13(4):313-330 https://doi.org/10.1111/j.1745-4573.2002.tb00339.x
35. Tompkin, RB, HACCP in the meat and poultry industry. Food Control 1994. https://doi.org/10.1016/0956-7135(94)90075-2
36. Mayes T, How can the principles of validation and verification be applied to hazard analysis? , Food Control, 1999, 10(4/5), 277-279. https://doi.org/10.1016/S0956-7135(99)00018-3
37. Weddig, LM, HACCP: A Systematic Approach to Food Safety, 3' Ed., The Food Processors Institute, Washington, D.C. 1999, pp. 81-84
38. NACMCF. Hazard analysis and critical control point principles and application guidelines. Journal of Food Protection. 1998; 61:762-775.
39. Sandle T, Mattia MD, Leavy C, Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control: Assessing microbial risks and to determining environmental monitoring locations, European Journal of Biomedical and Pharmaceutical Sciences, 2019; 243:18-45 https://doi.org/10.37521/ejpps.24302
40. King, P, Implementing a HACCP program, Food Management, 1992; 27(12):54,56,58
41. Sohrab, Risk assessment a pre-requisite for application of HACCP in food industries, Indian Food Packer, 1999; 53(4):43-50
42. Tompkin, RB, In HACCP in Meat, Poultry and Fish Processing Advances in meat research series, Blackie Academic & Professional, London, 1995: 72-108 https://doi.org/10.1007/978-1-4615-2149-5_5
43. Snyder, OP, HACCP in the retail food industry, Dairy, Food and Environmental Sanitation, 1991; 11(2):73-81.
44. Kvenberg J, Stolfa P, Stringfellow D, Garrett ES, HACCP development and regulatory assessment in the United States of America. Food Control, 2000; 11:387-401. https://doi.org/10.1016/S0956-7135(99)00090-0
45. Sperber WH, The modern HACCP system, Food Technology, 1991; 45(6):116, 118, 120.
46. Lupin HM, Internal auditing of HACCP-based systems in the fishery industry, INFOFISH International, 2000; 4:56-64.
47. Sperber WH, The role of validation in HACCP plans, Dairy, Food and Environmental Sanitation, 1999; 19(12): 912-920.
48. Dahiya S, Khar RK, Chhikara A, Opportunities, challenges and benefits of using haccp as a quality risk management tool in the pharmaceutical industry, Quality Assurance Journal, 2009; 12(2):95-104 DOI: 10.1002/qaj.446 https://doi.org/10.1002/qaj.446
49. Patil R, Gangadharappa HV, Kiran HC, Sandhya K, Planning of Hazard Analysis Critical Control Point (HACCP) in Pharmaceuticals, International Journal of Pharmaceutical Sciences Review and Research, 2016; 37(1):149-154
50. Bas M, Ersun SA and Kivanc G, Implementation of HACCP and prerequisite programs in food businesses in Turkey, Food Control, 2006; 17:118-126. https://doi.org/10.1016/j.foodcont.2004.09.010
51. Taylor E, HACCP in small companies: benefit or burdens, Journal of Food Control, 2001; 12: 217-222 https://doi.org/10.1016/S0956-7135(00)00043-8
52. Panisello PJ, Quantick PC, Technical barriers to hazard analysis critical control point, Food Control, 2001; 12(3):165-173. https://doi.org/10.1016/S0956-7135(00)00035-9
53. Mortlock MP, Peters AC, Griffith CJ, Food hygiene and hazard analysis critical control point in the United kingdom food industry: practices, perceptions and attitudes, Journal of Food Protection, l999; 62(7):786-792. https://doi.org/10.4315/0362-028X-62.7.786
54. Panisello PJ, Quantick PC, Knowles MJ, Towards the implementation of HACCP: results of a Uk regional survey, Food Control, l999; 10(2):87-90. https://doi.org/10.1016/S0956-7135(98)00161-3
55. Giampaoli J, Sneed J, Cluskey M and Koenig HF, School foodservice directors' attitudes and perceived challenges to implementing food safety and HACCP programs, The Journal of Child Nutrition & Management, 2002; 26(2)
56. Youn S, Sneed J, Training and perceived barriers to implementing food safety practices in school food service, The Journal of Child Nutrition & Management, 2002; 26(1).
57. Yadav H, Mahna R, Rekhi TK, HACCP system and difficulties in its implementation in food sector paripex, Indian Journal Of Research, 2015; 4(7):306-309
58. Maldonado ES, Henson SJ, Caswell JA, Leos LA, Martinez PA, Aranda G, Cadena JA, Cost-benefit analysis of HACCP implementation in the Mexican meat industry, Food Control, 2005; 16:375-381. https://doi.org/10.1016/j.foodcont.2004.03.017
59. Singh D, Kumar A, Singh A, HACCP In Clean Food Production: An Overview, International Journal of Research, 2018; 6(12):128-134 https://doi.org/10.29121/granthaalayah.v6.i12.2018.1096
60. Bauman HE. The origin and concept of HACCP. In: Pearson AM, Dutson TR, editors. HACCP in meat, poultry and fish processing. London: Chapman & Hall; 1995.P. 1-7. https://doi.org/10.1007/978-1-4615-2149-5_1
61. McAloon TR. HACCP implementation in the United States. In: Mayes T, Mortimore S, editors. Making the most of HACCP: learning from others' experience. England: Woodhead; 2003. P. 61-80. https://doi.org/10.1533/9781855736511.2.61
62. Ehiri JE, Morris GP, McEwen J, Implementation of HACCP in food businesses: the way ahead, Food Control, 1995; 6(6):341-5 https://doi.org/10.1016/0956-7135(95)00045-3
63. Bansal G, Parashar B, Dhamija H, The Application of haccp and Risk Management in the Pharmaceutical Process, Asian journal of pharmaceutical and clinical research, 2013; 6(2):21-25
64. Sandle T, Aseptic transfer risk assessment: a case study, Journal of Validation Technology, 2015; 21(1):1-10
65. Annalaura, C, Giulia D, Stefano C, The application of quality risk management to the bacterial endotoxins test: use of hazard analysis and critical control points, PDA Journal of Pharmaceutical Science and Technology, 2013; 67(5):553-67 https://doi.org/10.5731/pdajpst.2013.00938
66. Sandle T, Current methods and approaches for viral clearance, American Pharmaceutical Review, 2015; 18:1-4.
67. Ziegler I, Borbély-Jakab J, Sugó L, Kovács RJ, Revision of viable environmental monitoring in a development pilot plant based on quality risk assessment: a case study, PDA Journal of Pharmaceutical Science and Technology, 2017; 71(3):234-244 https://doi.org/10.5731/pdajpst.2016.007096
68. Bonan B, Martelli N, Berhoune M, Maestroni ML, Havard L, Prognon P, The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs, International Journal for Quality in Health Care 2009; 21(1), 44-50 https://doi.org/10.1093/intqhc/mzn052
69. Sandle T, Application of quality risk management to set viable environmental monitoring frequencies in biotechnology processing and support areas, PDA Journal of Pharmaceutical Science and Technology, 2012; 66(6):560-579 https://doi.org/10.5731/pdajpst.2012.00891
70. Bissett L, Developing decontamination strategies and monitoring tools, British Journal of Nursing, 2010; 19(16):12-17 https://doi.org/10.12968/bjon.2010.19.Sup6.78212
208 Views | 18 Downloads
How to Cite
Priya , Chaudhary M. Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review. JDDT [Internet]. 15Oct.2021 [cited 1Dec.2021];11(5-S):167-75. Available from: https://jddtonline.info/index.php/jddt/article/view/5094