What is a QP statement?
What is a QP Declaration? A QP Declaration is a document stating GMP compliance (equivalent to EU GMP) of an investigational medicinal product (IMP) manufactured in a non-EU member state (e.g. United States or China).
What is a QP in Europe?
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 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.
How do you get QP certified in NC?
Bachelor’s degree in Social Work, Social Services, Human Services or Special Education required; Master’s degree a plus. Minimum 2 years experience working with persons with population served is required; 1-year experience if paired with Master’s degree.
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 status in NC?
Persons who meet the requirements specified for Qualified Professional (QP) status have the knowledge, skills, and abilities required by the population and age to be served may deliver supports within the requirements of the staff definition specified in the service definitions.
What is a qualified professional in North Carolina?
What is a QP – Qualified Professional? 10A North Carolina Administrative Code 27G .0104 STAFF DEFINITIONS. “Qualified professional” means, within the MH/DD/SAS system of care: (a) an individual who holds a license, provisional license, certificate, registration or permit issued.