What is qp release

Perform a QP Risk Assessment of your Supply Chain Europe has market-specific quality requirements that must be achieved before the drug product can be used.

The entire supply chain end-to-end must be documented in a supply chain map see diagram 1 and risk-assessed. This includes everything from active pharmaceutical ingredient API to finished drug product. Using Consultants and Third Parties When using a consultant or third party for aspects of your QP release activities, it is essential the consultant is appropriately trained in all aspects of the supply chain they have been asked to play a part in.

A robust supply chain will typically involve multiple QPs engaged at different stages in the manufacturing process. It is also important to include this in all quality agreements to circumvent any impact to QP release.

In the QP study summary, it is important to document background information on the clinical trial, including a copy of the study protocol. In addition, a supply chain map see Diagram Regulatory Expectations of Supply Chain must be provided. This should include all manufacturing sites of the starting materials, packaging materials for the medicinal product and any other materials deemed critical through risk assessment of the manufacturing process.

You will be expected to provide detail for all manufacturing sites, including sub-contracted sites, considered to have potential impact on product quality, safety and efficacy. This is clarified by performing aformal risk assessment for the supply chain. Comparator sourcing. Label design. EU Qualified Person. Project Mangement.

Related Resources. The Alliance to Zero held its first onsite event last week in order to establish our working groups. We look forward to creating a common language and progressing our work in the months ahead. October 18th ClinStorage can release products manufactured in third countries for you. Do you want us to contact you?

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