Model Answers

Question 1

What are the legal duties of the UK QP and where are they found?

Answer 1

Human commercial- 2012/1916 section 7 part 3

Batch manufactured and assembled in line with MA and notional law

In the case of importation from a 3rd country, batches undergo qualitative and quantitative analysis of the active component and any other tests pertaining to the MA

In the case of supply to the EU, security features are applied as per 2011/62 EC.

Certification is recorded in a register or equivalent document

Clinical trial for human use -2004/1031 section 6 part 43

Batches are manufactured and assembled in line with PSF and appropriate authorisations. Batches are manufactured to GMP.

In the case of batches manufactured in a 3rd country, these must be manufactured to UK GMP standards inclusive of any comparators.

Veterinary commercial- 2013/2033 schedule 2 section 1 part 11.

As human commercial but no security features and certification drawn up in control report.

Batches are tested and meet specification listed in the PSF.

Certification is recorded in a register or equivalent document.

Question 2

You are the QP for a UK MA holder. Your products API is made in China, formulated in the EU and packed in the UK for uk release. What needs to be in place?

Answer 2

API

Regulatory;
MA reflecting manufacture site
QP declaration via audit
Local authority GMP certificate
NCA approval for every batch vs EU GMP part 2 (not on MHRA approved list OR white list)
QP duties compliant- supply maps, validation etc.
GMP;
Audited
QTA
Distribution agreements

Formulation

Regulatory;
EU site has MIA and QPs
GMP CERT
Listed in MA
QP duties met
GMP;
Audited
QTA (inc. QP responsibilities)
Distribution arrangements

Pack in UK

Regulatory;
MIA and QPs in the UK site.
GMP CERT
No batch import testing
Reference and retain held in the UK.

Question 3

You want to move your API supplier from UK to one in China. How would you expect this to be managed?

Answer 3

Understand reason for change and immediacy. Are there any supply constraints?

What is the product?

Change control

Regulatory- MA Variation, QP declaration via audit, Local GMP certificate in China. NCA written confirmation for all batches required. QP operational duties requirements (supply chain maps etc)

Patient- Bio equivalence study for new manufacture, stability studies, cross contamination and cleaning validation requirements.

PQS- documentation for validation, SOPs, batch records translated ect. Equipment and utility validation. Personnel oversight and training, production validation and TT. Analytical TT and verification.

GMP- audit site, QTA and distribution agreements.