Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario. We are continuing with our no deal planning to ensure we are fully prepared.
This guidance provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).
The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C
The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines state that qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified
This document provides guidance for the production of Water for Injection (WFI) by means other than distillation. The principles may be applied to other qualities of water produced, meeting other specifications.
The following guideline is to be seen in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014
Answer: The safety features consist of two elements placed on the packaging of a medicinal product: (1) a unique identifier, a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed
“Suspect” medicines can be divided into three main categories of products as follows: (a) substandard medicines Also called “out of specification”, these are authorized medicines that fail to meet either their quality standards or their specifications, or both …