Tuesday, August 30, 2011

EU GMP Guide: New Requirements added for Batch Certification

In Part III of the EU GMP Guide, a document on internationally harmonised requirements for batch certification has been added. It is applicable in the context of Mutual Recognition Agreements (MRA), Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAA) and other appropriate arrangements on GMP with the European Union.
Each batch of medicinal product transferred between countries having appropriate arrangements on GMP, must be accompanied by a batch certificate issued by the manufacturer in the exporting country. In the framework of MRAs all manufacturing sites must be located in the country issuing the certificate or in another MRA country, if reciprocal arrangements are in force. In the framework of the European Union's ACAA with Israel (once in operation) all quality control sites must be located in Israel or the EU.
The respective certificate should be issued further to a full qualitative and quantitative analysis of all active and other relevant constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation of the importing country. It shall attest that the batch meets the specifications and has been manufactured in accordance with the marketing authorisation of the importing country. The batch certificate should be signed by the person responsible for certifying that the batch is suitable for release for sale or supply/export. For the EU, that's the Qualified Person (QP).
Where applicable this batch certificate shall also be used for non-finished medicinal products such as intermediates, bulk or partially packed products.
The certificate may also be used for active pharmaceutical ingredients (API) and investigational medicinal products (IMP) used in clinical trial authorisations.

Click here to download the full document

Thoughts, ideas and quality.

Its been a long time in my endeavour to blogging or more precisely writing my thoughts. Not because, I was too occupied, or lack ideas, but somehow I was lagging the enthusiasm for writing. Anyhow, better later than never and so I am back again.

In one of my earlier post, I mentioned about quality as an idea. This is just an extension of my earlier though emphasising on thought and idea and their correlation with quality.

Ideas emerge from thoughts and thoughts are numerous, continuous, useful or may be gibberish at times, but thoughts provide a good soil for ideas to grow. A thoughtful mind is full of ideas which are are instantaneous, triggered by passion for resolving issue or to find ways of moving forward.

Quality is perception towards object or happening. An idea is an impetus to this perception. Ideas emerge when there are thoughts. 

Quality of thoughts, design ideas and will generate same quality of ideas.