When QP declaration is required?

A QP declaration is required to be submitted with all applications for new marketing authorisations, renewals and submissions of relevant quality variations, concerning changes (addition or replacement) to the manufacturer of a starting material and / or to the registered manufacturer(s) of the active substance.

What is a QP certification?

Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU.

What is a QP in pharma?

A Qualified Person is a technical term used in EU pharmaceutical regulation. The regulations specify that no Batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements.

What is QP GMP?

QP declaration is required for marketing authorisations to confirm that the active substance has been manufactured in accordance with good manufacturing practice for medicinal products. Keywords: Qualified person’s (QP) declaration, good manufacturing practice (GMP), compliance.

What is batch release certificate?

Government batch release certificates issued by certain governmental authorities for specific biological products provide additional confirmation that a given batch has been released, without necessarily giving the results of testing. The latter are contained in the manufacturer’s certificate of analysis.

Who can be Qualified Person?

Registered Contractors (RC) The RC appointed to carry out the necessary rectification and repair works under the MWIS shall be an RGBC or RMWC who is qualified to carry out minor works belonging to the class, type and item for which they are registered.

How can I become a Qualified Person in pharma?

Applicants are expected to have an Honours Bachelor degree ideally 2.1 or above extending over 3 or 4 years in one of the following disciplines: chemistry, pharmaceutical chemistry, biological sciences, medicine and technology; other disciplines may also be considered as suitable.

Is GMP a legal requirement?

Active substance manufacturers must comply with GMP. In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP. Importers of active substances intended for the EU market are also required to register.

How many types of registered qualified persons are there?

There are 3 different types of Registered Qualified Person (RQP): a vet who is registered with the Royal College of Veterinary Surgeons (RCVS) a pharmacist who is registered with the General Pharmaceutical Council (GPhC) or the Pharmaceutical Society of Northern Ireland.

What is Qualified Person UK?

“jobseeker” means an EEA national who satisfies conditions A, B and, where relevant, C; “qualified person” means a person who is an EEA national and in the United Kingdom as— (a) a jobseeker; (b)

When was the QP declaration template developed for European Medicines Agency?

Template Template developed for European Medicines Agency by Fiona Lewis and Vanessa Crookes December 2009 21 May 2014 EMA/334808/2014 Compliance and Inspections Department Qualified Person’s declaration concerning GMP compliance of the active substance manufacture “The QP declaration template” Reference Number ____________________

Why do I need a QP declaration for a marketer?

Marketing authorisations require a QP declaration to confirm that the active substance has been manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products for human and veterinary use, Part II: Basic Requirements for Active Substances used as Starting Materials2.

What is the legal basis for the qualified person?

The Legal Basis for the Qualified Person is defined in the DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 6 NOVEMBER 2001 ON THE COMMUNITY CODE RELATING TO MEDICINAL PRODUCTS FOR HUMAN USE.