Batch Release without a QP - Is this possible?

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7/8 May 2024

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One might think that the release of a batch of a medicinal product without the certification of a QP is not possible.  Batch certification by a QP is one of the essential requirements in the EU GMPs before a batch can be released to the market.

In Article 48, the Directive 2001/83 requests that EU Member States have to assure that each holder of a manufacturing authorization has to have at least one QP. Annex 16 to the EU-GMP Guidelines states that "the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)."

However one company in Spain has released products to the market without the QP. This was observed in an inspection by the Spanish Agency of Medicines and Medical Devices. The results were now published in the EudraGMDP database (Report No : ES/NCR/GMP/1/2018).

In this company, "batches have been released for several months without QP certification". It seems that in this company there is not too much to do for a QP, because a "complete absence of records of activities, use, cleaning and maintenance in the authorized manufacturing areas and equipment" was also observed.  Furthermore "unauthorised areas were used for manufacturing medicinal products".

Of course, the respective manufacturing authorisation was suspended and the current valid GMP certificate withdrawn. All batches not certified by a QP are being recalled.