Role + Duties of QP Flashcards
What are legal duties of Commercial QP?
UK SI 2012/1916 Sh7 part 3
2001/83/EC Article 51
Ensure each batch is manufactured and assembled in line with MA and national law
For products manufactured outside of the UK, the batch needs to undergo full qualitative analysis and quantitative analysis for active components and undergo all other tests to meet MA requirements (Exception for approved countries for batch importation- SWI, AUS, ISR, NZ, CAN, USA, JP, EU/EEA)
In the case of supply to the EU, security features to be applied (2011/62/EC)
All of the above recorded in register or equivalent document.
What are the legal duties of an IMP QP?
UK SI 2004/1031 Part6 section 43
2017/1569- Article 12
Each batch is manufactured and assembled to meet requirements of PSF and relevant approvals (CTA)
Each batch is manufactured to UK GMP standards inclusive of comparators.
Each batch is tested and meets specifications outlined in the PSF.
All of the above is recorded in register or equivalent document.
What are the legal duties of a vet QP?
UK SI 2013/2033 Schedule 2 part 1 Section 11
2019/6 Article 97
Ensure each batch is manufactured and assembled in line with MA and national law
For products manufactured outside of the UK, the batch needs to undergo full qualitative analysis and quantitative analysis for active components and undergo all other tests to meet MA requirements (Exception for approved countries for batch importation- SWI, AUS, ISR, NZ, CAN, USA, JP, EU/EEA)
Each batch is certified and listed in a control report.
What are the QP operational responsibilities?
Found in Annex 16
Section 1.6
Certification of a batch is permitted under the site MIA
The batch complies with national law
Certification is performed
Section 1.7
Sourced and starting material compliant with MA
TSE status compliant with MA
Sites of manufacture, testing and certification are compliant with MA
Activities at sites of certification and testing are compliant with MA
Security features applied for EU
QC results for finished product meet specification
Post market commitments are met inclusive of ongoing stability programme
Supply chain maps up to date and available to the QP
Activities on sites ensure appropriate GMP
Appropriate GMP for excipients
QTAs in place where required
API manufactured to GMP and distributed to GDP
API imported to requirements of article 46b of 2001/83
Arrangements in place for storage and distribution
Sites have been audited and reports available to the QP
Current and active SI programme at each site
Changes to manufacture/test don’t impact release
Investigations don’t impact release
Complaints and recalls don’t impact release
Validated status of process and equipment remains in place
Documentation reviewed by authorised personnel and IPCs performed.
What are the changes brought forward by EUFMD?
Falsified medicines directive 2011/62/EC
1. Security features on packaging
2. Supply chain and distribution practice- Wholesaler and broker licencing and registration
3. API written confirmation from national authority+ Excipient risk assessment requirements
4. Internet sales logo
ICH Chapters
1- Stability
2- AM validation
3- Impurities
4- Pharmacopoeia
5- Biotechnology
6- Specifications
7- Drug substance manufacture GMP
8- Pharm Dev
9- QRM
10- PQS
11- Development of DS
12- Lifecycle mgt
13- Continuous manufacture
14- Analytical procedure development
If you want to take samples in 3rd country- what are requirements?
Annex 16 provides guidance
Equivalent transport as batch
Technical justification + RA
Audit of sampling process and manufacture
Scientific study
-Comparative analysis- transport conditions, process of sampling, time limit for storage
Random periodic sample for bulk testing
Review any unexpected/ confirmed OOS
What do you find in API QP declaration?
Written template- EMA guidance
Manufacturer details
MIA impacted by API source
Basis of compliance (audit report)
>3 years interval needs justification
Declaration- QP, GMP compliance, Tech agreement
QP sign and date, MAH and number.
You’ve had an unexpected deviation- what do you need to be in place to release the batch?
Guidance present in Annex 16
All specifications met
No impact to safety, quality, efficacy
No impact on long term stability
Root cause understood and preventative actions raised
Can only occur once- repeat incidences are not permitted
Consider safety impact to biologics- unexpected consequences.
When do you contact the DMRC?
Potential for restriction of supply
Potential for faulty medicine on market
Detection of falsification
What are the Eudralex volume 4 chapters?
- PQS
- Personnel
- Premises and Equipment
- Documentation
- Production
- Quality Control
- Outsourced activities
- Complaints and product recall
- Self inspection
What is the approval route with MHRA?
Application of CTD vial MHRA portal
National procedure
Innovative licencing pathway available
If samples are requested to be taken in a 3rd country, how would this be justified?
Annex 16- Sampling in 3rd country
Technically justified approach
-QRM- risks identified
-Audit of facility, manufacture and sampling process
-Scientific study to demonstrate equivalence and representative sampling
-Description of sampling/transport
-Comparative analysis (in house vs 3rd country)
- Time interval consideration
Periodic (Annual) in house sampling
Written agreement
Shipped under equivalent transport conditions as bulk
What needs to be in place for releasing all batches based on first batch QC data from bulk?
Release decision for all finished packs can be based on QC results from first batch using same bulk material
Documented justification
Bulk storage prior to packaging conditions
Finished product batch storage and transport
Tampering consideration
Samples tested need to be representative of bulk material
What is parallel importation?
What are the QP requirements for Parallel importation?
What licences are required?
What is parallel importation?
-Repackaging/over labelling activities on certified material should be approved by competent authority of intended market.
-Medicinal products imported from one member state to another without permission of company owning IP.
-Medicinal product authorised on one member state can be marketed in another providing there is no therapeutic difference.
What are the QP requirements for Parallel importation?
-Prior to certification of over labelled/re-packed material, QP to confirm compliance with national PI requirements and EU rules for distribution.
-QP certifies re-packaging has been performed in accordance with required authorisation and GMP.
-Safety features as 2011/62 must be in place (Legal duty)
What licences are required?
-MIA needed for re-packaging
-WDA needed for import, storage and distribution
-PI Simple- product to be imported manufactured by same group of companies, common origin
-PI Standard- Not common origin , not complex
-PI complex- Not common origin, new excipient, API made by different route than used in UK authorised product, Controlled release, sterile product with different sterilisation method, Sterile product, different container material, Flu vaccine, MDI, DPI, BA studies not demonstrated, Evidence of S/E date is published literature, Different active substance manufacturer
