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Flashcards in Role of QP Deck (11):

Which directive defined legal duties of QP?

75/319/EEC - human
85/851/EC - Vet
Consolidated into 2001.83.EC and 2001.82.EC


What are the legal duties of a QP?

Each batch of product has been maufactured in compliance with: National Law + Req of MA + GMP
Each batch of product imported from outside EU/EEA: full qualitative test + quantitative on API + other tests required by MA
Testing exempt where MRA in place - base certification on CoA received
QP must cerfity in a register or equivalent document before release
Each batch of product has a safety feature affixed on the outer packaging - FMD 2011.62.EC
IMP are manufactured and assembled according to:
The appropriate authorisations
all testing has been carried out and resutls comply with PSF
Imported IMP - EU GMP
Comparators outside EU - EU GMP equivalent, if not test


What is the structure of Annex 16?

1. Scope
2. Principle
3. Introduction
4. General
5. Batch testing and release of products MFG in EC/EEA
6. Batch testing and release of products imported from third country
7. Batch testing and release of products imported from a MRA third country
8. Routine duties of a qualified person


What are the routine duties of a QP

Per Annex 16 Section 8
Before certifying a batch prior to release the Q.P. doing so should ensure, with
reference to the guidance above, that at least the following requirements have been
a) the batch and its manufacture comply with the provisions of the marketing
authorisation (including the authorisation required for importation where
b) manufacture has been carried out in accordance with Good Manufacturing
Practice or, in the case of a batch imported from a third country, in
accordance with good manufacturing practice standards at least equivalent to
c) the principal manufacturing and testing processes have been validated;
account has been taken of the actual production conditions and
manufacturing records;
d) any deviations or planned changes in production or quality control have been
authorised by the persons responsible in accordance with a defined system.
Any changes requiring variation to the marketing or manufacturing
authorisation have been notified to and authorised by the relevant authority;
e) all the necessary checks and tests have been performed, including any
additional sampling, inspection, tests or checks initiated because of
deviations or planned changes;
f) all necessary production and quality control documentation has been
completed and endorsed by the staff authorised to do so;
g) all audits have been carried out as required by the quality assurance system;
h) the QP should in addition take into account any other factors of which he is
aware which are relevant to the quality of the batch


What are the key principle of Annex 16?

Only one QP responsible for releasing all parts of each production batch in the EU
Acknowledges potentially complex arrangments for MFG of medicinal products
QP may not be able to be invovled with every asepct of MFG
May need to rely on advice/decisions of others
QP need to establish this reliance is well founded: Personal knowledge + Expertise of people invovled + confidence in the quality system
If some MFG outside EU - MFG and testing must be in accordance with MA and EU GMP
Importance of TA in line with Chapter 7 of GMP guide
Cover: deviations, OOS, complains and other matter QP needs to know
All MFG at a single site - within EU
QP certifies and releases
Can delegate certain checks and controls - within a defined quality system
Different stages of MFG at different sites of same company
Each stage should be under responsibility of a QP
Certification of finished proudct batch by a QP of the MAH resonsible for releaseing batch to market
Certifying QP may take acount of certification of earler stages by the releant QPs
Arrangment to be defined in a wirtten agreement
Certain intermediates watdes contracted to a different company
QP of MAH respnosible for batch release (contract giver) - responsible for final certification and release
Can take accoutn of cerificaiton by QP of contractor acceptor
Arrnagements to be defined in a written contract
Bulk assembled at different sites into finished product batches and released under a single MA
Either bulk QP release
or QP release at assembly site
Take account of certification
Written agreement
Bulk MFG assembled at different sites into serveral fninshed product batches and released in different MA
QP assembly site certifies and release
Take account of bulk QP
Finished product pruchased and release under own MA
Purchasers QP certifies finisehd product for release
Take acc by QP of MFG


What do you expect to see in a BMR?

Product name/strength and dosage form
Dates and time: Start + significant steps + completion
Names: who did what + approved sig list + initials
Check of critical operations: Weighing + dispensing + reconciliations
Specific batch number / analytical reference
Results of IPC
Reconciliation data for production yields
Critical info: sterilisation records + EM reports + QC test results
Deviations/atypical events


What are the KPIs of a QMS?

Product returns due to errors
Rejected lots
BMR non conformances
Deviations and investigations
Internal and external audits
Adherene to programme and findings
CAPA closeout
Batches reworked
PQRs done on time


What is the legal basis of the QP code of practice?

Art 52 2001.83.EC
MS shall ensure that duties of QPs are fufilled either by appropriate admin means or by making QPs subject ot a prof code of conduct
SI 2004.1031: part 6 para 43(3): Code of practice


What are the regulatory basis for the QP?

GMP directive (Human) 2003.94.EC: Art 7
GMP directive (Vet) 91.412.EC: Art 7
CT Directive (Human): Art 13
Codification directive 2001.82.EC: MFG and importation Art 44-57
Codification directive 2001.83.EC: MFG and importation Art 40-53
Eudralex Vol 4: Annex 13 and Annex 16
Eudralex Vol 10: CT


What is the purpose of the code of practice?

Provide operational guidelines for carrying out the functions of the QP
In the interests of QP + patients + CA + employers


Content of a PQR?

Per Ch1 Eudralex (QMS)
Product Quality Review
1.10 Regular periodic or rolling quality reviews of all authorised medicinal products,
including export only products, should be conducted with the objective of verifying
the consistency of the existing process, the appropriateness of current specifications
for both starting materials and finished product, to highlight any trends and to identify
product and process improvements. Such reviews should normally be conducted and
documented annually, taking into account previous reviews, and should include at
(i) A review of starting materials including packaging materials used in the
product, especially those from new sources and in particular the review of
supply chain traceability of active substances.
(ii) A review of critical in-process controls and finished product results.
(iii) A review of all batches that failed to meet established specification(s) and
their investigation.
(iv) A review of all significant deviations or non-conformances, their related
investigations, and the effectiveness of resultant corrective and preventive
actions taken.
(v) A review of all changes carried out to the processes or analytical methods.
(vi) A review of Marketing Authorisation variations submitted, granted or
refused, including those for third country (export only) dossiers.
(vii) A review of the results of the stability monitoring programme and any
adverse trends.
(viii) A review of all quality-related returns, complaints and recalls and the
investigations performed at the time.
(ix) A review of adequacy of any other previous product process or equipment
corrective actions.
(x) For new marketing authorisations and variations to marketing
authorisations, a review of post-marketing commitments.
(xi) The qualification status of relevant equipment and utilities, e.g. HVAC,
water, compressed gases, etc.
(xii) A review of any contractual arrangements as defined in Chapter 7 to
ensure that they are up to date.
1.11 The manufacturer and, where different, marketing authorisation holder should
evaluate the results of the review and an assessment made as to whether corrective
and preventive action or any revalidation should be undertaken, under the
Pharmaceutical Quality System. There should be management procedures for the
ongoing management and review of these actions and the effectiveness of these
procedures verified during self-inspection. Quality reviews may be grouped by
product type, e.g. solid dosage forms, liquid dosage forms, sterile products, etc. where scientifically justified.
If not MAH then the responsibilities must be in a TA