European Medicines Agency (EMA) updates to the certification and batch release annex, published in 2002, will make it more relevant to the globalised and fragmented biopharmaceutical supply chain.
“Due to the increased complexity of supply chains the current guidelines on certification and release of batches manufactured [outside Europe] have become open to interpretation. This in turn, has led to lack of harmonisation in requirements between member states”, the EMA wrote .
This lack of harmonisation has raised questions about what documents are needed to move batches between countries in the European Union. The EMA plans to publish a draft of the revised document in December 2012 to harmonise the interpretation of legislation and GMP guidance across Europe.
Remote Qualified Persons
Part of the update will address the role of Qualified Persons (QP) now the supply chain is outsourced and globalised. “The QP may be quite far removed from and may have lost personal familiarity with the products and the manufacturing sites”, the EMA wrote.
However, the responsibilities of QPs are still the same as when they were located at the site where production and quality control testing of a batch occurred. The EMA wants to reemphasise the role of the QP and for prerequisites for release of a batch to be “clearly and unambiguously determined”.
“Specifically, the extent of personal involvement of the QP versus reliance on quality systems and other personnel particularly needs to be clarified where manufacture takes place at a site which is remote from the QP”, the EMA wrote.
In drafting new documents the EMA will consider the impact on active pharmaceutical ingredients, excipients and finished products. The EMA will also check if guidance on investigational medicinal products needs revising.