Law and Admin Flashcards
What are the MRA approved countries list for batch importation?
Isreal
Australia
Swi
NZ
Can
JP US
EU/EEA
Certain restrictions for ATMPs, Blood products, Medicinal gasses, Homeopathics
When do you need MIA? When do you need WDA?
MIA- Manufacture and importation licence- allows manufacture, import and distribution for products made at that site.
WDA- when you import and distribute products from other sites.
What is the role of PIC/s?
Pharmaceutical inspection co-operation scheme.
Set standards for inspectorates globally, train auditors from national authorities and provide audit guidance (aid memoirs).
You need to recall material. What actions do you need to take?
May be prior to root cause
Understand where the batches are
Determine how far into supply chain you recall to
Inform all competent authorities
Market specific recall actions
Secure storage
What are API importation controls?
New MA or variation requires API QP declaration approval
If 3rd country and not approved for active substance manufacture to UK GMP, needs to have national competent authority approval from country of manufacture
GDP guidance 2015/c95/01
EUFMD 2011/62/EC
What controls measures are in place for excipients?
Guidance present in Eudralex vol 4 section 3 - excipients RA.
-2015/c95/02 GDP guidance
What is present in the non- clinical module of the CTD?
Toxicology information
Interactions
ADR
Carcinogenicity
Sensitisation
Max dose in animals
What are responsibilities of QPPV
Monitor market reported ADRs
Create and maintain effectiveness of PV system
Prepare PV reports
Respond to HA requests
What types of licenses are available?
MIA
WDA
MIA IMP
Specials Licence
Veterinary Licence
API registration
Broker registration
What is contained in manufacturing licence?
Authorisation number
Name of holder
Address
Legal basis (SI)
Date of authorisation
Scope of authorisation
- Sterile
-Non-sterile
- Packaging
-QC
-Imported goods
Named QPs + Heads of manufacture and QC.
Contract labs for release testing
What is contained in site master file?
Guidance document in part 3 eudralex volume 4
1. General information on the manufacturer
2. PQS elements
3. Personnel
4. Premises and equipment
5. Documentation
6. Production activities on site
7. QC
8. Distribution/ complaints and recall
9. Self inspection
Appendixes
- Copy of site licence
- Copy of GMP certificate
- Contract manufacturers and QC labs
- Key personnel
- Key equipment
- Water systems
- Plant layouts
What is in the CTD and where do you find guidance on this?
Common technical document- contains;
Module1- Regional information
Module 2- Quality, non clinical summary/overview, clinical summary/overview
Module 3- Quality module
Module 4- Non clinical study reports
Module 5- Clinical study reports
Format found in ICH M4 and M8
What is contained in the Quality module of the CTD?
P.3.2S- Drug substance
-General Information
-Characterisation
-Manufacture
-Control of DS
-Stability
-Container closure
-Reference standards
P.3.2P Drug product
-Description and composition
-Pharm Dev
-Manufacturing process and controls
-Excipient control
-Control of DP
-Reference standards
-Stability
-Container closure system
What are the routes of MA application in the EU? Who reviews them?
National procedure- One country
Mutual recognition procedure- MA in one country and others recognise
Decentralised- Apply to one reference country and many others at same time
Centralised- through EMA, EU wide application
CHMP and CVMP review applications.
What are the MA application routes for the UK? What licences do the MHRA currently issue?
National procedure
Reliance procedure (IRP)
Innovative licencing and access pathway
PLUk PLNI, PLGB
