Role Of The QP Flashcards
What does EU Directive 2001/83/EC Article 51 pertain to?
Legal duties for the quality assurance of human medicine
What does UK SI 2021/1916 Schedule 7 part 3 address?
Legal duties for quality assurance of human medicine in the UK
What are the key responsibilities of a Qualified Person (QP) for each batch of human medicine?
Manufactured and assembled in accordance with:
* National Law
* Marketing Authorisation (MA)
What must be certified for each batch of human medicine?
Certification in a register (or equivalent)
What additional requirements are there for imports from outside the EU/EEA?
Full Qualitative Analysis
Full Quantitative Analysis of active constituents
All other tests comply with the MA
Where MRA in place accept on CofA
What is accepted when a Mutual Recognition Agreement (MRA) is in place?
Acceptance on Certificate of Analysis (CoA)
What safety features must be affixed to packaging according to FMD 2011/62/EU?
Safety features for authenticating medicine packaging (not applicable for UK/NI)
What is the responsibility of the qualified person referred to in Article 48?
To ensure that each batch of medicinal products is manufactured and checked in compliance with laws and marketing authorization requirements.
This applies to both products manufactured within Member States and those imported from third countries.
What must be done for medicinal products coming from third countries?
Each production batch must undergo a full qualitative analysis, a quantitative analysis of at least all active substances, and all necessary tests to ensure quality.
This must be in accordance with the requirements of the marketing authorization.
What safety features must be affixed to the packaging of medicinal products intended for the Union market?
The safety features referred to in point (o) of Article 54.
These features are critical for ensuring product safety.
Under what condition can batches of medicinal products be exempt from controls when marketed in another Member State?
If they are accompanied by control reports signed by the qualified person.
This ensures that proper checks have been conducted in the original Member State.
What must be ensured regarding manufacturers of imported medicinal products from third countries?
They must apply standards of good manufacturing practice at least equivalent to those laid down by the Community.
This is essential for maintaining quality control.
What is the qualified person’s certification requirement when medicinal products are released for sale?
The qualified person must certify that each production batch satisfies the provisions of the Article in a register or equivalent document.
This documentation must be kept up to date and available for competent authority review.
How long must the register or equivalent document be kept available for review?
For at least five years.
This period may be specified further by the provisions of the Member State concerned.
Fill in the blank: The qualified person may be relieved of responsibility for controls if appropriate arrangements have been made by the Community with the _______ country.
exporting
