Around the world Flashcards
Scenario, supply chain: API is made in China, dosage form is made in Turkey, primary & secondary packaging is performed in Switzerland, final release in UK. What do you need to consider and make sure is in place as a QP.
API – China
QP Declaration
Audit (EU GMP)
TA
Named on the MA
MANF – Turkey (Non-EU)
Audit (EU GMP)
Audit by local Authorities
TA
Named on the MA
Pack - Switzerland
MRA – with EU – accepted in UK on the approved countries list
QC Testing needs to be performed – C of A and C of A required
TA in place
Named on the MA
UK – QP Release
MIA
TA – with all of above
Vendor Assurance / Supply Chain Risk Assessments
GDP
You have an API manufactured in South Korea, the bulk is manufactured in Switzerland, the product is packed and QP released by you in the UK. What documentation and controls would you need for each stage to enable release?
Relevant Guidance?
API’s 2001/83/EC, 1252/2014 and 2015/C95/01
Medicinal Product – 2001 / 83/EC . SI20212/1916, Commercial 2017/1572 and 2013/C343/01
API Stage?
QP Declaration
Audit
Technical Agreement
South Korea is on the List of Approved Countries so written confirmation isn’t required.
Bulk Stage?
Switzerland is on the list of approved countries for batch testing therefore no need to perform re-testing in the UK.
C of C and C of A required
Audit
Technical Agreement
Require Retain and Reference Samples
Importation into UK?
MIA – ensure dosage form covered in product list
QP release of bulk by UK QP based on Switzerland documentation prior to packing
Define if Finished Product Pack testing is required
Release?
Certification – based on CofC, CofA, Packing MBR ,
If distribution to the EU then Serialisation needs to be considered and – will require certification from EU QP
API manufacture in Singapore, drug product manufacturer in Turkey, import testing and QP certification in UK. What would you expect to be in place for this scenario? What would you need to see before you certify the first batch?
API
o TA
o Audit – Company / Regulatory
o QP Declaration – written confirmation not required as being sent to Turkey
o Named on MA
Turkey
o TA
o Named on MA
o Audit – Company / Regulatory
o Request Retain / Reference samples
UK
o MIA – covered the product
o Full Qualative / Quantative Analysis of the medicinal Product
o Samples require technical justification of samples
o Random sampling as per Annex 16 once a year
o Named on MA
o TA in place with all sites
o Audit reports available to the QP
Supply chain - API regulatory considerations
Site Named on MA
GMP Cert Issued by local Authority
White List Considerations Versus Written Confirmation
QP Declaration
CEP Available
Eudra GMP Check
TSE Compliance
Supply chain - API GMP considerations
Audit – by MAH / Site of QP Release
Technical Agreements
Transport Requirements – GDP Qualified Route
Supply Chain Maps
Master Batch Doc Translation Available
Nitrosamine Risk Assessments
Supply chain - API routine considerations
Written Confirmation if API direct to EU
Batch Documents Needed?
C of C / C of A
Transport Requirements – GDP Qualified Route
Deviations / Changes
Ongoing Complaints
Supply chain - Formulation / Pack Regulatory considerations
Site Named on MA
Product Processes comply with MA
GMP Cert Issued by local Authority
EU GMP Cert
MIA – if EU Site
Consider MRA’s – could testing be conducted here
Supply chain - Formulation / Pack GMP considerations
Audit – by MAH / Site of QP Release
Technical Agreements
Transport Requirements – GDP Qualified Route
Supply Chain Maps
Master Batch Doc Translation Available
Location of Retain and Reference Samples – must be in EU if batches going to EU
Samples to test site – representative
Method Transfer
Process Validation
Supply chain - Formulation / Pack Routine considerations
C of C / C of A – if batches tested in EU – Responsible Person for Import
Transport Requirements – GDP Qualified Route
Serialisation Requirements – for EU
Deviations / Changes / OOS
Batch Documents Needed?
Sampling Aspects compliant with Annex 16
Random Sampling
Supply chain - Testing and certification Regulatory considerations
Site has MIA – QP Named, Product Listed as Imported
Site Named on MA for Product
GMP Cert Issued by local Authority
TSE Compliance
EU GMP Cert
WDA requirements considered – If QP Certified in Europe RPI
QPPPV Location and Available all Times
Supply chain - Testing and certification GMP considerations
Responsible for all Technical Agreements
Full Supply Chain Maps
Transport Requirements – GDP Qualified Route
Location of Retain and Reference Samples – must be in EU if batches going to EU
Samples to test site – representative
Method Transfer
Supply chain - Testing and certification Routine considerations
C of C / C of A – if batches tested in EU – Responsible Person for Import
Transport Requirements – GDP Qualified Route
Serialisation Requirements – for EU
Deviations / Changes / OOS
Batch Documents Needed?
Sampling Aspects compliant with Annex 16
Certification Process
