Qualified Persons (IMP) Don Wallace Regional QA Pharmacist 27 th May 2014

Transcription

1 Qualified Persons (IMP) Don Wallace Regional QA Pharmacist 27 th May 2014

2 Introduction EU Clinical Trials Directive 2001 came into existence in the UK in May 2004 (Part 6 Manufacture of Investigational Medicinal Products (IMPs)) Must be complied with by Require an IMP licence granted by MHRA to manufacture batches of product - A QP is required to release batches of IMPs

3 NHS Position Many NHS manufacturing facilities applied for IMP licences Under the transitional arrangements, personnel involved in releasing batches of clinical trials materials prior to the introduction of the legislation provided information together with a supporting CV to the MHRA to be named as a QP (IMP) on the licence

4 NHS Position Survey performed in Approx. 40 NHS sites (14 Radiopharmacy) - Approx. 70 QPs (35 under transitional arrangements). 10 retiring within next 10 years Northern Ireland - 1 NHS IMP site (Victoria Pharmaceuticals) - 3 QPs (2 RPQAS, 1 WHSCT)

5 New QPs Must become a full QP - Pharmacist, Microbiologist, Chemist through respective professional bodies. - Extensive and relevant experience working in pharmaceutical industry. - Extensive knowledge through study; formulation, microbiology, statistics, clinical trials, APIs, law, etc. - Viva

6 RPQAS (services to VP) QA Service QP Services Microbiological Testing Chemical analysis QA Service Victoria Pharmaceuticals Audit Co-ordinate QMS Documentation Approval Sterility testing

7 Requests We have a drug that needs labelled (overlabelled) We need a supply of active and placebo capsules/tablets We require stock of a product for a multicentre trial We have a trial material that is being made up on a lab bench and we wish to scale up manufacture to supply in a clinical trial

8 Roles and Responsibilities of QP Pre- manufacture (GCP) Has a general overview of the complete trial; including conversant with trial protocol Attends meetings; partakes in conference calls; with investigators/sponsors/r&d/ct personnel Ensures that all authorisations and documentation is complete prior to manufacturing the first batch of trial material Reviews and approves trial documentation prior to manufacture, e.g. TAs, Product Specifications

9 Pre-manufacture (GMP) Assures formulation of the product is appropriate Ensures the stability of the product plus assigned expiry Ensures the quality of the starting materials and packaging components Assesses starting materials documentation (C of As, TSE compliance, Imported products docs, SmPCs) Approves all production and QC documentation

10 Batch Production Provides QP release certificates for all batches Ensures that the products released are fit for their intended purpose Ensures that all aspects of manufacture comply with GMP For complex randomisation, blinding and labelling activities, supervises the labelling process

11 General In depth knowledge and understanding of manufacture and distribution Audits of external suppliers Internal audits of manufacturing areas Deals with customer issues Co-ordinates recalls Ensures temperature compliance during storage and transport

12 General Keeps up to date with legislation and training requirements Gains relevant knowledge of new products prior to involvement as a QP Participation in regulatory inspections(mhra) Deals with general queries about the products Liaises with other QPs

13 QP Involvement The QP has involvement from the initial requests through pre-trial manufacture, manufacture and right through the duration of the trial.

14 Future Advanced Therapies? Novel products? Chemotherapy? Do I have the expertise to act as a QP for this trial?

15 Questions Later!