Role & Duties Flashcards
Legal duties of a commercial human medicines QP
D 2001/83 - Article 51
SI 2012/1916 sc7 pt3
QP must ensure:
1. Batch is Certified & recorded in a register
2. Manufactured & assembled in accordance with national law
3. If imported from outside of EU:
a. Full qualitative analysis
b. Quantitative analysis of actives
c. Compliance with MA
d. Where MRA exists, CofA can be accepted
Legal duties for veterinary QP
R 2019/6 - article 97
SI 2013/2033 sch 2 pt 1
- Batch certified and recorded in a control report
- Manufactured and assembled in accordance with national law
- Imports from outside EU:
a. Full qualitative analysis
b. Quantitative analysis of actives
c. All other tests compliant with MA
d. Where MRA applies, can accept CofA
Legal duties of IMP QP
R 536/2014
SI 2004/1031sc43 pt6
- Each batch to be certified and recorded in a register
- Manufacturer & Assembled in accordance with: GMP, PSF & appropriate authorisations
- Imports from outside of EU - made to EU equivalent GMP
- Testing to be carried out and results comply with PSF
What are the QPs 2 overarching duties
- Protect patient from harm
- Protect their business from harm
What are the operational duties of a QP, and where would you find them?
Eudralex vol 4, ANNEX 16 part 1.6 & 1.7
Non-delegatable duties:
1. Certification is permitted under terms of MIA
2. Any additional duties & requirements of national legislation are complied with
3. Certification is recorded in a register of equivalent
Delegatable:
Investigations
TSE
Sites
QC
Activities
Validation
API
Inspections
Distribution
Excipients
Records
Supply chain
Marketing
Audits
GMP
Imports
Changes
Complaints
Agreements
Tamper
Source & spec
Under what circumstance can you release with an unexpected deviation
- Negligible impact on the quality, safety or efficacy of the batch
- Consideration of the need to include the batch on stability programme
- Must be within specification
- Cannot be a repeat
May require update/ variation to MA
What are the 5 parts which make up API declaration
A. Concerned sites (name & address)
B. MIAH in which QP declaration applies
C. GMP compliance (detail of audits)
D. QP declaration
E. Name & signature of QP
What is the legal framework of QPPV
EU: 2001/83 a 101-108
R 726/2004
UK: 2012/1916 part ii
CTR 2044 part 1
Eudralex volume 9
Purple guide
QPPV responsibilities
MA holder should have permanently at their disposal a QP responsible for PV
- Establish & maintenance of MAH PV system
- Prepare PV reports
- Answering requests from health authorities
Types of contract QP
- Part time
- Interim
- Sub-contracted
- Retained
Legal basis for QP code of practice
EU D 2001/83 article 52
Member state shall ensure that the duties of QPs as per a. 48 are fulfilled by means of appropriate admin measures or by making QP subject to a professional code of conduct
Structure or QP code of practice
- Intro
- Regulatory basis of QP
- Purpose of code
- Terminology
- General principals
- Principle duties of QP
- Performance of duties
- Membership & location of QPs
- Contracted QPs
- Outsourced activities
- CPD
- Professional conduct
- Professional bodies
- Disciplinary procedures
