A Comprehensive Review on Documentation Practices in the Pharmaceutical Manufacturing Industry

Thanuja R.; K. Vinod Kumar; Byreddy Divya Sree; Karthick S.; T Reshma

doi:10.35516/jjps.v17i4.1405

Authors

Thanuja R. Department Pharmaceutical Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research, K R Palli Corss, Chiyyedu, Anantapur, Andhra Pradesh, India.
K. Vinod Kumar Department Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research, K R Palli Corss, Chiyyedu, Anantapur, Andhra Pradesh, India.
Byreddy Divya Sree Department Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research, K R Palli Corss, Chiyyedu, Anantapur, Andhra Pradesh, India.
Karthick S. Department Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research, K R Palli Corss, Chiyyedu, Anantapur, Andhra Pradesh, India.
T Reshma Department Pharmaceutical Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research, K R Palli Corss, Chiyyedu, Anantapur, Andhra Pradesh, India.

DOI:

https://doi.org/10.35516/jjps.v17i4.1405

Keywords:

Documentation, Validation Protocols, SOP's, FDA, Pharmaceutical Industry

Abstract

This review sheds light on the crucial role of documentation in the pharmaceutical manufacturing industry, a sector where quality control and regulatory compliance are critical. Documentation, from standard operating procedures to validation protocols, underpins quality assurance systems by shaping and improving manufacturing processes. We examine its significance in maintaining product quality, patient safety, and meeting regulatory requirements, particularly in FDA and EMA audits. Additionally, we explore the digital transformation in documentation practices, introducing of electronic batch records, and the associated challenges and opportunities. The paper underscores the necessity for robust, accurate, and timely documentation, emphasizing it as a pledge to product quality, patient safety, and public health.

References

Sreelekha S., Kumar K.V., Mahammed N., Reshma T., Sree G.U., Basha S.S. and Bhuvaneswari M. Quality by Design Approaches in Pharmaceutical Development and Solid Dosage Forms Production: A Narrative Overview. Jordan Journal of Pharmaceutical Sciences. 2023; 16(4): 770-84. DOI: https://doi.org/10.35516/jjps.v16i4.908

Kumar K. Good Documentation Practices (GDPs) in Pharmaceutical Industry. Journal of Analytical & Pharmaceutical Research. 2017; 4(2):00100. DOI: https://doi.org/10.15406/japlr.2017.04.00100

Simonovski N. and Gjorgjeska B. Documentation as an integral part of quality assurance in the pharmaceutical industry. Knowledge–International Journal. 2022; 54(4): 807-11.

Ventegodt S. M. and Merrick J. M. The pharmaceutical industry and documentation. Journal of Alternative Medicine Research. 2011; 3(4):453.

Aghajani E., Nagy C., Vega-Márquez O.L., Linares-Vásquez M., Moreno L., Bavota G., Lanza M. and editors. Software documentation issues unveiled. 2019 IEEE/ACM 41st International Conference on Software Engineering (ICSE). 2019; IEEE. DOI: https://doi.org/10.1109/ICSE.2019.00122

Bloswick A. and Skowron H.A. Informed consent documentation in pharmaceutical industry-sponsored clinical trials. Ethics & Medicine: An International Journal of Bioethics. 2015; 31(1):51-9.

Jiang X., Zhou Y., Ming W., Yang P. and Wu J. An overview of soft open points in electricity distribution networks. IEEE Transactions on Smart Grid. 2022. DOI: https://doi.org/10.1109/TSG.2022.3148599

Figer B.H., Sapra K.P., Gogtay N.J. and Thatte U.M. A comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies. Perspectives in clinical research. 2020; 11(1):13. DOI: https://doi.org/10.4103/picr.PICR_122_18

Kolekar P. and Bhagwat A. Good documentation practices: a need of pharmaceutical industry. Asian Journal of Research in Chemistry. 2021; 368-374. https: //doi.org/10.52711/0974-4150.2021.00063. DOI: https://doi.org/10.52711/0974-4150.2021.00063

Serge S. and Serracino-Inglott A. Standard operating procedures in pharmaceutical quality systems. 2012.

Salvarina I., Gravier D. and Rothhaupt K.O. Seasonal bat activity related to insect emergence at three temperate lakes. Ecology and Evolution. 2018; 8(7):3738-50. DOI: https://doi.org/10.1002/ece3.3943

Orwa J., Keter L., Ouko S., and Kibwage I. Influence of manufacturing practices on quality of pharmaceutical products manufactured in kenya. East African Medical Journal. 2004; 81(6). https: //doi.org/10.4314/eamj.v81i6.9177. DOI: https://doi.org/10.4314/eamj.v81i6.9177

Mousa M., Hilal Y. and Swed A. Determination of iron in liposomal dosage forms by flame atomic absorption spectrometry after an acidic digestion. Jordan Journal of Pharmaceutical Sciences. 2020; 13(4).

Huang J., Serra T., Garcia P. and Irwin S.H. To batch or not to batch? The release of USDA crop reports. Agricultural Economics. 2022; 53(1):143-54. DOI: https://doi.org/10.1111/agec.12667

Alkhatib H., Barqawi A. and Alhawmdeh E. Effect of casein incorporation on the release of diltiazem HCl from hypromellose-based matrix tablets. Jordan Journal of Pharmaceutical Sciences. 2018; 11(2).

Stasis A., Whyte J. and Dentten R. A critical examination of change control processes. Procedia CIRP. 2013; 11:177-82. DOI: https://doi.org/10.1016/j.procir.2013.07.053

Bradley G. Benefit Realisation Management: A practical guide to achieving benefits through change: CRC Press. 2016. DOI: https://doi.org/10.4324/9781315569055

Masli A., Peters G.F., Richardson V.J. and Sanchez J.M. Examining the potential benefits of internal control monitoring technology. The Accounting Review. 2010; 85(3):1001-34. DOI: https://doi.org/10.2308/accr.2010.85.3.1001

Torkzadeh G. The Quality of User Documentation an Instrument Validation. Journal of management information systems. 1988; 5(2):99-108. DOI: https://doi.org/10.1080/07421222.1988.11517827

Allenet B., Bedouch P., Rose F-X., Escofier L., Roubille R., Charpiat B., et al. Validation of an instrument for the documentation of clinical pharmacists’ interventions. Pharmacy World and Science. 2006; 28:181-8. DOI: https://doi.org/10.1007/s11096-006-9027-5

Agalloco J.. Why Validation? Handbook of Validation in Pharmaceutical Processes: CRC Press. 2021; 1-4. DOI: https://doi.org/10.1201/9781003163138-1

Bower J., McClung J., Watson C., Osumi T., and Pastre K. Recommendations and best practices for reference standards and reagents used in bioanalytical method validation. the Aaps Journal. 2014; 16(2):352-356. https: //doi.org/10.1208/s12248-014-9566-y DOI: https://doi.org/10.1208/s12248-014-9566-y

Carlucci S., Bai L., de Dear R. and Yang L. Review of adaptive thermal comfort models in built environmental regulatory documents. Building and Environment. 2018; 137:73-89. DOI: https://doi.org/10.1016/j.buildenv.2018.03.053

Glick S., Guggemos A., editors. IPD and BIM: benefits and opportunities for regulatory agencies. Proc, 45th Associated Schools of Construction National Conference. 2009.

Harrigan E., Leahy R. and Youtcheff J. Superpave manual of specifications, test methods and practices. SHRP-A-379. Strategic Highway Research Program. 1994.

Hall P., editor Towards testing with respect to formal specification. Second IEE/BCS Conference: Software Engineering, 1988 Software Engineering 88. IET. 1988.

Narayana S., Pati R., and Vrat P. Research on management issues in the pharmaceutical industry: a literature review. International Jogdpurnal of pharmaceutical and Healthcare Marketing. 2012; 6(4):351-375. https: //doi.org/10.1108/17506121211283235. DOI: https://doi.org/10.1108/17506121211283235

Butcher N.J., Mew E.J., Monsour A., Chan A-W., Moher D. and Offringa M. Outcome reporting recommendations for clinical trial protocols and reports: a scoping review. Trials. 2020; 21(1):1-17. DOI: https://doi.org/10.1186/s13063-020-04440-w

Newman E. and Kaloupek D.G. The risks and benefits of participating in trauma‐focused research studies. Journal of Traumatic Stress: Official Publication of The International Society for Traumatic Stress Studies. 2004; 17(5):383-94. DOI: https://doi.org/10.1023/B:JOTS.0000048951.02568.3a

Wilkinson A. Protocol transplant biopsies: are they really needed? Clinical Journal of the American Society of Nephrology. 2006; 1(1):130-7. DOI: https://doi.org/10.2215/CJN.00350705

Khoja S.S., Khoja S.S., Khoja F.S., Khoja S.S. and Pirani N.A. A Review on Quality Agreement requirement in Pharmaceuticals by Regulatory Authority in Compliance to cGMP Guidelines. PharmaTutor. 2017; 5(5):24-8.

Jefford M. and Moore R. Improvement of informed consent and the quality of consent documents. The lancet oncology. 2008; 9(5):485-93. DOI: https://doi.org/10.1016/S1470-2045(08)70128-1

Chowdary B. and George D. Improvement of manufacturing operations at a pharmaceutical company. Journal of manufacturing Technology Management. 2011; 23(1):56-75. https: //doi.org/10.1108/17410381211196285 DOI: https://doi.org/10.1108/17410381211196285

Doolani S., Wessels C., Kanal V., Sevastopoulos C., Jaiswal A., Nambiappan H., et al. a review of extended reality (xr) technologies for manufacturing training. Technologies. 2020; 8(4):77. https: //doi.org/10.3390/technologies8040077 DOI: https://doi.org/10.3390/technologies8040077