ALCOA+ and Data Integrity

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-15-2020
Volume 2020 eBook
Issue 1
Pages: 10-13

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.

Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 10–13

Citation

When referring to this article, please cite it as S. J. Schniepp, “ALCOA+ and Data Integrity," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).

 

 

Articles in this issue
Guidelines_225.jpg
Resources, Guidelines, and Guidance Documents
Orgs_225.jpg
Regulatory and Standard Setting Organizations
PTebook0320_004-005_RegulatoryActionUpdate_Peters.gif
A ‘New Normal’ for Quality?
Pharmacopoeia 1_225.jpg
Monograph Development: Why and When to Participate (eBook)
Pharmacopoeia 3_225.jpg
Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon (eBook)
Pharmacopoeia 2_225.jpg
A Practical Approach to Pharmacopoeia Compliance (eBook)
PTebook_cellandgene.jpg
Inside FDA’s New Gene and Cell Therapy Guidances
PT ebook_ALCOA.jpg
ALCOA+ and Data Integrity
Recent Videos
CPHI Milan 2024: Compliance and Automation in Aseptic Processing
Related Content
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

Feliza Mirasol
November 19th 2024
Article

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

J&J’s Balversa Gains MHRA Marketing Authorization as Monotherapy for Bladder Cancer

Feliza Mirasol
November 8th 2024
Article

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification

Paul L. Pluta
November 8th 2024
Article

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

The Importance of Appropriate Supplier Oversight

Siegfried Schmitt
November 2nd 2024
Article

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.