BioPharm International - March2020

BioPharm International - Regulatory

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www.biopharminternational.com March 2020 BioPharm International eBook 7 • Original: Original or source data are the record, report, notebook etc. where the data point was initially recorded. • Accurate: The data recorded must be complete, consis- tent, truthful, and represen- tative of facts. • Complete: Information that is critical to recreating and understanding an event. This would include any repeat or reanalysis performed on a lab- oratory test sample. • Consistent: The data are pre- sented, recorded, dated, or time-stamped in the expected and defined sequence. • E n d u r i n g : T h e d at a o r information must be main- tained, intact, and accessible throughout their defined retention period. • Available: The data or infor- mation must be able to be accessed at any time during the defined retention period. Data integrity has always con- cerned regulatory authorities, but it is important to understand what is prompting the renewed discus- sion of ALCOA and the introduc- tion of ALCOA+ when discussing data integrity issues. Many of the concepts for ALCOA have been captured in the regulations as far back as 1978. A GROWING INDUSTRY Since that time, the industry has changed dramatically. The gener- ic-drug industry has grown and in the United States alone accounts for more than 80% of the prescrip- tions written today (2). Coupled with the emergence of biosimi- lars, virtual companies, contract m a nu f ac t u r i n g or ga n i z at ion s, rapid adva nces i n automat ion and information technology, and the globalization of the industry have resulted in reinterpretation of the attributes associated with maintaining the integrity of data throughout the product lifecycle, whether those data are generated from electronic, paper-based, or hybrid systems. I n add it ion, t here has b een an increase in citations interna- tionally by the FDA, European M e d i c i n e s A g e n c y ( E M A ) , Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organization (WHO), and other health authorities. These changes and increased violations have brought about a resurgence and need to reeducate the industry on the basic principles and con- cepts regarding the proper control of data used to support the quality and safety of medicines. DATA INTEGRITY REGULATIONS The A LCOA acrony m has been used since the 1990s; however, the requirements governing data ele- ments have been in regulations for a much longer period of time. EudraLex chapter 4 states, "Suitable controls should be implemented to ensure the accuracy, integrity, availability, and legibility of doc- uments. Instr uction documents should be free from errors and available in writing" (3). The US Code of Federal Regulations (CFR) refers to these elements in various sections of the regulations (4–8). An example for language speak- ing to the element of attributable is in 21 CFR 211.194(a)(7), which states, "The initials or signature of the person who performs each test and the date(s) the tests were performed." Language in 21 CFR 58.130 (e) addresses the elements of contemporaneous and legible by stating, "All data generated during the conduct of a nonclinical labo- ratory study, except those that are generated by automated data col- lection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data." Recent documents issued by WHO (9) and the PIC/S (1) have added to the original ALCOA attributes as indicated above. The PIC/S docu- ment actually states, "Some key con- cepts of GDocPs are summarized by the acronym ALCOA: Attributable, Legible, Contemporaneous, Original, and Accurate. The following attri- butes can be added to the list: Complete, Consistent, Enduring, and Available. Together, these expecta- tions ensure that events are prop- erly documented and the data can be used to support informed deci- sions." WHO refers to ALCOA+ in the title of Appendix 1 to their 2018 document. The last two documents also address the concept of quality culture (10). The impact to an orga- nization is that the quality culture must ensure that data supporting the quality and safety of a product must now meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues. REFERENCES 1. PIC/S, Draft Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PIC/S, August 2016). 2. statista.com 2019. 3. EC, EudraLex,The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Chapter 4. 4. 21 CFR 11: Electronic Records; Electronic Signatures 5. 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies 6. 21 CFR 211: Current Good Manufacturing Practice for Finished Pharmaceuticals 7. 21 CFR 212.50: Current Good Manufacturing for Positron Emission Tomography Drugs 8. 21 CFR 820: Quality System Regulation 9. WHO, Annex 5, Guidance on Good Data and Record Management Practices (WHO, June 2016). 10. S. Schniepp, Pharmaceutical Technology 42 (10) 2018. BP Regulatory Sourcebook Data Integrity

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