Quality of medicines questions and answers: Part 2

Table of contents

These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP.

They provide the EEA's harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures.

If a question is not addressed, marketing-authorisation holders are encouraged to contact the European Medicines Agency (EMA) for further information.

These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents.

Key:

Acceptability of two different appearances (shape, dimensions, colour) for a single strength tablet in a single Marketing Authorisation

Appearance of tablets of different strengths

Definition of ‘active substance’ in relation to mixtures

Active substance - Veterinary Medicinal Products (VMP) containing 100% Active Substance (V) NEW Sept. 2018

Design of in-use shelf life for solid oral dosage forms in multi-dose containers

Claims for in-use shelf-life for solid oral dosage forms in multi-dose containers

Packaging

Particles originated from the container closure system

Quality data requirements to demonstrate suitability of multidose containers for preservative free eye drops NEW October 2018

Reduced testing of starting materials

Setting specifications for impurities in veterinary medicinal products

Specific type of products – Dry product inhalers

Specific types of product - Graduation of measuring devices for liquid dosage forms

Specific types of product - Need for in vitro dissolution studies with alcohol for modified-release oral products including opioid drug products

Specific types of product - Needle safety systems

Specific types of product - Orally inhaled products

Specific types of product - Quality of investigational medicinal products

Specific types of product - Eye drops

Specific types of product - Veterinary medicinal products

Stability - Article-58 products

Stability - Declaration of storage conditions

Stability - Endotoxin testing and sterility testing at the end of shelf-life

Stability - Generics versus the innovator product

Stability - Reduced design in stability studies

Stability - Stability issues of pharmaceutical bulk products use in manufacture of the finished product

Storage

Water

How useful was this page?

Add your rating
Average
2 ratings
3 ratings
1 rating
3 ratings
2 ratings