Quality of medicines questions and answers: Part 1

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.


Requirements for selection and justification of starting materials for the manufacture of chemical active substances in veterinary medicinal products

Removal of heavy metals tests from a specification - Substances with a Ph. Eur. monograph in existing marketed products

Active Substance - Active-substance-master-file (ASMF) procedure

Active substance – API mix

Active substance - Declaration by the qualified person on the good-manufacturing-practice status of the active substance manufacturer

Active Substance - Good-manufacturing-practice compliance for sterilisation of an active substance

Active Substance - Starting materials of herbal origin

Change in the appearance of tablets during storage

Data submission

European Pharmacopeia (Ph. Eur.) - Harmonised Ph. Eur. Chapters 2.6.12, 2.6.13 and 5.1.4

European Pharmacopeia - Monograph on tablets

European Pharmacopeia (Ph. Eur.) - Harmonised chapter uniformity of dosage units

Impurities - Calculation of thresholds for impurities

Impurities - Residual solvents

Manufacture of the medicinal products - Process control

Vancomycin drug products

Removal of heavy metals tests from a specification - Substances without a Ph. Eur. monograph in existing marketed products


Use of peptones in the manufacture of active substance


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