Significance of Personnel Hygiene Practices in Pharmaceutical Industry
Personnel hygiene is very important in the pharmaceutical industry to prevent or reduce any kind of contamination which can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors must to be upheld. Good personnel hygiene policies and practices are the foundation for successful product safety and purity. They are the backbone of a meaningful Good manufacturing Practices (GMP). Proper personnel training and sanitation are of prime importance. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. All personnel should undergo medical check-up which may be a prerequisite for safe working condition. Personnel hygiene policies and procedures are to be followed by all personnel including management, visitors, production, sanitation and maintenance staff, for reducing the chance of product contamination. Personnel hygiene practices and procedures play a vital role in pharmaceutical industry in order to achieve a good quality and safe product.
2. Frederick T. The do’s and don’ts of food plant personal hygiene practices. Food Safety Magazine [Internet]. 2005 [cited 2021 Oct 09]. Available from:
3. FDA’s Current Good Manufacturing Practice (cGMP) - 21CFR § 211 define the “current good manufacturing for the Finished Pharmaceuticals [Internet]. 2021 Jan 10 [cited 2021 Oct 11] Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211& show FR=1 &subpartNode= 21:18.104.22.168.11.2
4. Hall J. Personal hygiene standards. In Food hygiene auditing [Internet]. Springer, Boston [cited 2021 Oct 09]; 1997:112-27. MA. Available from:
5. Sutton S. Hand washing, hygiene, CGMP, and science. Journal of GXP Compliance [Internet]. 2010 [cited 2021 Oct 12]; 14(1):62 Available from:
6. Rackham M, McHattie GV, Teasdale EL. Occupational hygiene measurement strategy in the pharmaceutical industry. Occupational Medicine [Internet]. 1989 Mar 1 [cited 2021 Oct 12]; 39(1):15-18. Available from:
7. Melero B, Diez AM, Rovira J. Basic Sanitation. Handbook of Fermented Meat and Poultry [Internet]. 2014 Oct 02 [cited 2021 Oct 09]; 441-49. Available from:
8. Aarnisalo K, Tallavaara K, Wirtanen G, Maijala R, Raaska L. The hygienic working practices of maintenance personnel and equipment hygiene in the Finnish food industry. Food control [Internet]. 2006 Dec 1 [cited 2021 Oct 13];17(12):1001-11. Available from:
9. Shobowale EO, Adegunle B, Onyedibe K. An assessment of hand hygiene practices of healthcare workers of a semi-urban teaching hospital using the five moments of hand hygiene. Nigerian medical journal: journal of the Nigeria Medical Association [Internet]. 2016 May[cited 2021 Oct 13]; 57(3):150 Available from:
10. Premnath S. Handbook of pharmaceutical quality assurance. Bengaluru: 1st Edition; 2016:63-82.
11. Instructions to be displayed in different areas [Internet]. [cited 2021 Oct 20]. Available from:
12. Gowning-procedure-food-packaging [Internet]. [cited 2021 Oct 20]. Available from:
13. People at work with secondary gowning [Internet]. [cited 2021 Oct 20]. Available from:
14. Bhusnure OG, Dongare RB, Gholve SB, Giram PS. Chemical hazards and safety management in pharmaceutical industry. Journal of Pharmacy Research [Internet]. 2018 [cited 2021 Oct 13];12(3):357-69. Available from:
15. Pai DR, Kamath KK, Subrahmanyam EVS, Shabaraya AR Personal Training for Pharmaceutical Industry. Int. J. of Pharm. Quality Assurance [Internet]. 2016 [cited 2021 Oct 12]; 7(3):55-61. Available from:
16. Reham M, Haleem MY, Salem FA, Fatahallah LEA. Quality in the pharmaceutical industry – A literature review. Saudi Pharma J [Internet].. 2015 [cited 2021 Oct 12]; 23(5):463-69. Available from:
17. Maintaining Hygiene in the Pharmaceutical Industry: A Glimpse of Effective Practices to Implement 9.1. [Internet] 2020 [cited 2021 Oct 14] Available from: https://lindstromgroup.com/in/article/maintaining-hygiene-in-the-pharmaceutical-industry-a-glimpse-of-effective-practices-to-implement/
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM