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June 05, 2013
The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
June 02, 2013
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
May 28, 2013
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.
The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.
May 14, 2013
FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.
May 02, 2013
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
April 23, 2013
FDA issues draft guidance to minimize medication errors.
April 17, 2013
FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
April 12, 2013
Prefilled-syringe line features automation and novel disinfection techniques.
April 02, 2013
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.