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|October 13, 2016
FDA Warns Swiss Company
Author(s)Pharmaceutical Technology Editors
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
Advertisement
FDA issued a
During the inspection, FDA found the company had failed to establish quality control unit responsibilities and procedures for reviewing out-of-specification results and customer complaints. Investigators were told that the company had no independent quality unit.
Specific quality issues that were observed included a failure to test finished batches of drug product for identity and strength of active ingredients and a failure to identify components sourced from suppliers. A lack of proper cleaning and maintenance was also observed.
FDA recommended the company engage a qualified consultant to help meet CGMP requirements. The agency stated it may refuse admission of drug products that have not been manufactured under CGMP guidelines.
Source:
Advertisement
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