Safety Features for Medicinal Products for Human Use
regulatory,

Safety Features for Medicinal Products for Human Use

This document sets out frequently-asked questions and answers concerning the implementation of the rules on the safety of medicinal products for human use.
These rules are enshrined in Articles 47a, 54 (o) and 54a of 2001 / 83 / EC Directive, and Commission Delegated Regulation (EU) 2016 / 1612.

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Guideline on the sterilization of the medicinal product, active substance, excipient and primary container
regulatory,

Guideline on the sterilization of the medicinal product, active substance, excipient and primary container

Guidance is provided on the appropriate methods of sterilization for sterile products.
Although, terminal sterilization using a reference condition of the European Pharmacopoeia (Ph. Eur.)
is the method of choice when possible
sterilizing processes, sterilizing filtration or aseptic processing,
an additional post-aseptic processing terminal heat treatment), could be accepted as an alternative.

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regulatory,

FDA Quality Considerations for Continuous Manufacturing

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).

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regulatory,

Reflection paper on the qualification of non-genotoxic impurities

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

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