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 QP agreement?
Q: A contract manufacturer's QP certifies a finished product, confirming the compliance with GMP . ... Usually the Technical or Quality Agreement contains an annex, describing the requirements of the marketing authorisation like manufacturing process, test methods and specifications.
What is a QP certificate?
Qualified Person . A Qualified Person (QP) is responsible for assuring the quality of medicines. That's why it's important that QPs are rigorously trained, with an in-depth understanding of pharmaceutical manufacture.
What is a QP release?
In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). For a QP to certify a batch of a drug product the QP is required to be named on a licence known as an MIA (Manufacturer's/ Importation Authorisation).
How do you become QP certified?
1) A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study ...
What does EudraLex stand for?
EudraLex is the collection of rules and regulations governing medicinal products in the European Union .
How do you qualify to be a European citizen?
- QP has to be named by the Marketing Authorization Holder in the EU and must be registered/ accepted by the EU member state where the company resides.
- QP has to be linked to an existing European Manufacturing Authorization and license [EU/European Consumer Centre (ECC)]
What does QP mean in drugs?
QP — The slang term for a quarter pound of marijuana . This is the amount that your drug dealer friend in high school probably bought from his “guy” and then grossly overcharged you for the labor of breaking it up into eighths and grams.
Who is responsible for batch release?
The finished product batch should be certified by a Q.P. of the manufacturing authorisation holder responsible for releasing the batch to the market. 5.4 A bulk production batch is assembled at different sites into several finished product batches which are released under a single marketing authorisation.
What is batch release meaning?
A batch release is a certification of a medicinal product or a drug by an authorized person . The batch release must be done before the products are introduced into free trade.
What is a QP role?
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 quality?
A Qualified Person (QP) is a key figure in the quality assurance of medicines produced by pharmaceutical companies.
What do you mean by the term qualified person?
A qualified person ( electrical equipment ) is a person who has received training in, and has demonstrated skills and knowledge in the construction and operation of electrical equipment and installations. ... The definition of a qualified person will depend on the unique circumstances in each workplace.
Who can be a QP?
Information on the criteria to become a Qualified Person. An eligible QP is either a pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations.
Who can be a qualified professional for a person?
Qualified professional means a professional engineer, surveyor, financial analyst or planner providing services within the scope of the person's license, education or experience.
How does OSHA define a qualified person?
“Qualified” means one who, by possession of a recognized degree, certificate , or professional standing, or who by extensive knowledge, training, and experience, has successfully demonstrated his ability to solve or resolve problems relating to the subject matter, the work, or the project.
