OR WAIT null SECS
March 07, 2017
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
March 02, 2017
The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.
February 28, 2017
Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
February 21, 2017
Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.
February 17, 2017
The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.
February 15, 2017
Process conditions can corrode stainless-steel surfaces, necessitating corrective and preventive maintenance.
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.