Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|September 15, 2019
- Pharmaceutical Technology-09-15-2019
- Volume 2019 eBook
- Issue 2
Quality Culture Drives Patient Confidence in Drug Products
Author(s)Rita C. Peters
While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.
Advertisement
While patients generally trust that the drugs they take are safe, product recalls, drug shortages, reports of potential contaminants, and publicized regulatory enforcement actions can shake public confidence in the drug supply. While FDA looks to encourage voluntary compliance over the “stick” approach of tighter enforcement, bio/pharma companies are encouraged to build a quality culture throughout the organization, starting with top executives at the company.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 4–5
Citation
When referring to this article, please cite it as R. Peters, “Quality Culture Drives Patient Confidence in Drug Products," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).
Articles in this issue
about 7 years ago
What’s New in Regulations and Complianceabout 7 years ago
Generics: Getting Beyond “File First, Figure it Out Later”about 7 years ago
Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)about 7 years ago
Why Pharmacopoeia Compliance Is Difficult (eBook)about 7 years ago
Why Pharmacopoeia Compliance Is Necessary (eBook)about 7 years ago
Resources, Guidelines, and Guidance Documentsabout 7 years ago
Regulatory and Standard Setting OrganizationsAdvertisement
Related to this article
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Advertisement
Advertisement