Need more information regards QP release India? When manufacture medicinal or investigational medicinal products in India, defined as a third country with respect to EU, the product has to be released by a Qualified Person (QP) for use in EU. With regard to QP release of products manufactured in India, there are some slight differences in the actual application process, and how it is handled compared to EU. This is because you must face the specific laws and regulations in India as well as the requirements set for EU. ClinStorage handles the complete manufacture process and related applications.
A QP release of products manufactured in India will work as the application process for a QP release certificate in any other country outside of EU, but will be a subject to some variations in its characteristics. A QP release of products manufactured in India will be based on the QA release of the company is situated in India, where the manufacturing process takes place. Further, to gain sufficient knowledge of the manufacture and controls, the QP or delegate typically performs audit/s of the facilities in India used.
What does it mean to be a QP release in India?
As stated before, the QP will be needed if the manufacturing takes place within the boundaries of India which is applicable to Indian laws and regulations. The actual QP release for use of products in EU, is the be performed by a QP certified from a competent authority in EU
With that said, the QP will not have to be an actual employee and/or manufacturer, but is required that the sponsor or the Market Authorization holder to have a contract with the company i.e. ClinStorage, in question to act as their QP for EU.
What is needed from a QP to gain the status to be release for EU?
Requirements for a QP release:
- QP certified with a European authorization
- Thorough and skilled examination of process and controls, and documentation associated.
- Legal agreements in place
- Be an employee with any European manufacturing authorization, from a the Medical Products Agency.
This is a must when acting as a QP release in India, and other third countries outside of EU boundaries. This is required, not optional.
ClinStorage will assist you all the way from the design of product to importation and release for use in EU
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