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Annex 13 Investigational Medicinal Products 2010

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EU Guidelines to Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use

Annex 13 - Investigational Medicinal Products


Annex 13 Titel

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In our handy format DIN A 6 to have this important guideline always with you:

appr. 47 pages

Investigational medicinal products should be produced in accordance with the principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products (The Rules Governing Medicinal Products in The European Community, Volume IV). Other guidelines published by the European Commission should be taken into account where relevant and as appropriate to the stage of development of the product. Procedures need to be flexible to provide for changes as knowledge of the process increases, and appropriate to the stage of development of the product.

In clinical trials there may be added risk to participating subjects compared to patients treated with marketed products. The application of GMP to the manufacture of investigational medicinal products is intended to ensure that trial subjects are not placed at risk, and that the results of clinical trials are unaffected by inadequate safety, quality or efficacy arising from unsatisfactory manufacture.

Equally, it is intended to ensure that there is consistency between batches of the same investigational medicinal product used in the same or different clinical trials, and that changes during the development of an investigational medicinal product are adequately documented and justified.

The production of investigational medicinal products involves added complexity in comparison to marketed products by virtue of the lack of fixed routines, variety of clinical trial designs, consequent packaging designs, and the need, often, for randomisation and blinding and increased risk of product cross-contamination and mix up.

Furthermore, there may be incomplete knowledge of the potency and toxicity of the product and a lack of full process validation, or, marketed products may be used which have been re-packaged or modified in some way.

These challenges require personnel with a thorough understanding of, and training in, the application of GMP to investigational medicinal products.

Co-operation is required with trial sponsors who undertake the ultimate responsibility for all aspects of the clinical trial including the quality of investigational medicinal products.

The increased complexity in manufacturing operations requires a highly effective quality system.

The Annex also includes guidance on ordering, shipping, and returning clinical supplies, which are at the interface with, and complementary to, guidelines on Good Clinical Practice.


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