Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 13
Recent documents issued by WHO (9) and the
PIC/S (1) have added to the original ALCOA attributes
as indicated above. The PIC/S document actually
states, "Some key concepts of GDocPs are summa-
rized by the acronym ALCOA: Attributable, Legible,
Contemporaneous, Original, and Accurate. The fol-
lowing attributes can be added to the list: Complete,
Consistent, Enduring, and Available. Together, these
expectations ensure that events are properly docu-
mented and the data can be used to support informed
decisions." WHO refers to ALCOA+ in the title of Ap-
pendix 1 to their 2018 document. The last two docu-
ments also address the concept of quality culture (10).
The impact to an organization 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 PIC/S, Draft Guidance: Good Practices for Data Man-
agement and Integrity in Regulated GMP/GDP Envi-
ronments (PIC/S, August 2016).
2. statista.com 2019.
3. EC, EudraLex,The Rules Governing Medicinal Prod-
ucts in the European Union, Volume 4, Good Manu-
facturing 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 Pos-
itron 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.
PT
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