Annex 21 Flashcards
Tell me about Annex 21
Details the GMP requirements for products imported in the EU and EEA by holders of a Manufacturing Import Authorisation (MIA).
Requirements:
European GMP rules or equivalent standards shall be followed for the manufacturing in third countries.
The manufacturing process has to comply to the one described in the Marketing Authorisation (MA), the clinical trial authorization (CTA).
A risk assessment is needed to justify the frequency for the review of the full batch documentation at the site responsible for QP certification/confirmation.
A segregated quarantine area should be available to store the incoming products until released for further processing or QP certification/confirmation.
The relevant quality agreement in place between the MAH and the manufacturer.
Certification can only take place in the EU once the product has cleared customs.
Sites responsible for QP certification to verify:
an ongoing stability program is in place at the third country site where manufacturing is performed.
verification that reference and retention samples are available
Safety features are placed on the packaging, if required.
Regular monitoring and periodic on-site audits of the third country manufacturing sites
The verification of testing requirements, in order to confirm the compliance of the imported products to the authorised specifications detailed in the MA.
Generation of periodic Product Quality Reviews (PQR) should include:
An assessment of the basis for continued reliance on the sampling practice in third country, if applicable.
A review of deviations during transportation
A comparison to assess the correspondence of analytical results from importation testing with those listed by the Certificate of Analysis generated by the third country manufacturer.
Where does Annex 21 not apply
Does not apply to medicinal products entering the EU/EEA for export only.
Can manufacturing operations be run on imported bulk and intermediate products prior to the QP certification/confirmation.
Yes
What are the requirements of annex 21
European GMP rules or equivalent standards shall be followed for the manufacturing in third countries.
The manufacturing process has to comply to the one described in the Marketing Authorisation (MA), the clinical trial authorization (CTA).
A risk assessment is needed to justify the frequency for the review of the full batch documentation at the site responsible for QP certification/confirmation.
A segregated quarantine area should be available to store the incoming products until released for further processing or QP certification/confirmation.
The relevant quality agreement in place between the MAH and the manufacturer.
Certification can only take place in the EU once the product has cleared customs.
Procedures are in place for qp certification
Generation of the pqr is the responsibility of the importing site
What are the annex 21 QP certification responsibilities
an ongoing stability program is in place at the third country site where manufacturing is performed.
verification that reference and retention samples are available
Safety features are placed on the packaging, if required.
Regular monitoring and periodic on-site audits of the third country manufacturing sites
The verification of testing requirements, in order to confirm the compliance of the imported products to the authorised specifications detailed in the MA.
Annex 21 OQR is responsibility of importing site, what should be included
An assessment of the basis for continued reliance on the sampling practice in third country, if applicable.
A review of deviations during transportation
A comparison to assess the correspondence of analytical results from importation testing with those listed by the Certificate of Analysis generated by the third country manufacturer.
