Quality Assurance of Investigational Medicinal Products. Sue McKenzie PPQA (A)

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1 Quality Assurance of Investigational Medicinal Products Sue McKenzie PPQA (A)

2 Agenda for Today IMP Regulations - CTD and Annex 13 Role of QP for IMP Challenges of IMP Manufacture for the QP

3 IMP Regulations Clinical Trials Directive (2001/20/EU), Annex 13

4 IMP Regulations The Clinical Trial Directive became effective in the UK on 1 st May 2004 and has now been implemented across the EU The Directive brought into force the following requirements Clinical Trial Authorisations. authorise the sponsor to carry out a clinical study. Manufacturing Authorisations licence the facility for manufacture of Investigational Products. Good Manufacturing Practice Including Annex 13 Requirement for QP Certification of all batches

5 Clinical Trial Authorisations. Authorise the sponsor to carry out a clinical study and are study not product specific they include: Clinical Protocol Labels Clinical and safety data Investigational Medicinal Products Dossier (IMPD) which contains the CMC documentation. There is a single EEA reference number (EUDRACT) CTAs are assessed by each member state

6 Clinical Trial Protocol Defines the basic information and details for the study planned study objectives Procedures patient population clinical trial materials clinical laboratory testing safety assessments data analysis May be for a single or a multiple-site study Packaging, labelling and assembly requirements defined

7 CTA Amendments Amendments far more common than with licenced products New data becomes available as development progresses e.g. stability/shelf-life Function of the development process Route of synthesis for API will almost certainly be changed to improve yield and manufacturability. Formulation of drug product may change during development and when the process is optimised. Impact on existing studies which use materials currently in stock needs to be carefully assessed before submission

8 Manufacturing Authorisations Manufacturing Authorisations for Investigational Products authorise a site to carry out particular activities such as manufacture, assembly, import and distribution. No separate WDL Operations sites supplying IMP must be included in the IMPD and a copy of their Manufacturing Authorisation or GMP certificate may be required. CROs must be included in the IMPD and have a valid MA or GMP certificate, an agreement defining responsibilities of each party is required. The Clinical Pharmacology Units within AstraZeneca are included in the IMP Manufacturing Authorisation.

9 Good Manufacturing Practice The Rules Governing Medicinal Products in the European Union apply with some specific guidance in Annex 13 Annex 13 recognises the additional complexity of IMP in comparison to marketed products by virtue of the lack of fixed routines, variety of clinical trail designs, the need for randomisation and blinding and increased risk of crosscontamination and mix up.

10 Product Specification File Includes or refers to: Specifications and analytical methods Manufacturing methods In-Process testing and methods Approved Label Copy CT Protocols and randomisation codes Relevant technical agreements Stability data Storage and shipment conditions Etc.

11 The Role of the Qualified Person in IMP Manufacture PAR&D PPQA (A)

12 IMP Legal Duties (1) Ensuring that products have been manufactured and assembled according to GMP Product Specification File (PSF) Appropriate regulatory authorisations e.g. CTA Ensuring that all testing has been carried out and that results comply with the product specification

13 IMP Legal Duties (2) Ensuring that all IMP being imported from outside the EU has been manufactured to GMP at least equivalent to 2003/94 Ensuring that comparators sourced outside the EU and which have a marketing authorisation have been manufactured to GMP at least equivalent to 2003/94 Certifying in a register or equivalent document that the product has fulfilled these requirements and can be released for clinical evaluation

14 Legal Duties & PAR&D PPQA(A) So, how do we fulfill our Legal Duties?

15 Manufactured to GMP. Ensuring that suitable local GMP quality systems are in place Approving the GMP procedures and documents Ensuring that a GMP training program exists Providing expert advice and guidance to their line function on the interpretation of relevant GMP requirements Providing input into Compliance Improvement Plans

16 Manufactured to GMP. Providing expert advice and guidance to the line functions on the GMP design and validation requirements for new equipment and facilities Reviewing and approving validation documentation. Approving Change Control and investigations of deviations that affect existing processes and specifications. Auditing of internal Quality Systems. Management and approval of suppliers and contractors

17 Compliance with PSF QA Representative on the Therapeutic Area Project Team is involved in the approval of PSF PSFs are available in an electronic library QP checks library to ensure that PSF for a particular study is approved Change Control Process for Regulatory Submission updates is in place

18 Compliance with Regulatory Submission PSF and Change Control process is key IND/CTA/IMPD references are checked at Bulk Product release stage Regulatory approval status is checked for each market in an electronic database

19 Testing and Specification Compliance QA review the Specification Justifications and approve the Specifications C of As reviewed as part of Bulk Product release process for compliance with specification

20 Imported IMP/Comparators Auditing by PAR&D/GQO etc. MRAs Service Level Agreements Technical Agreements etc.

21 Certifying in a Register Records of ALL secondary pack releases are kept In electronic inventory management systems where relevant wet ink registers where electronic systems not used e.g. Contractor packed material IVRS Studies Exports Daily register is printed and signed by QP on routine release

22 Challenges of IMP Manufacture for the QP And how to overcome them.

23 Manufacturing Issues Various sites, including contractors, can be used Need to transfer between sites efficiently Multi-purpose facilities Capacity and scheduling issues Equipment may be different at smaller scale Cleaning verification/validation Development and GMP batches produced

24 Personnel and Training Issues Many non-routine jobs single batches Processes not robust training difficult Modifications required during processing Documentation skills required Change control, Deviations, Variances Possible incomplete safety profile

25 Documentation Issues Manufacturing Instructions not necessarily established or only provisional Specifications may change In-process controls may change Multi-product facility requires control of room/equipment logs etc

26 Comparator Issues (1) Blinding requires consideration of Coat and core colours Shape Size Thickness Smell/taste Weight Container design

27 Comparator Issues (2) CANNOT use market presentation for blinded studies Additional manufacturing steps may be needed Supported by stability data, expiry, etc. May need to develop and validate assay methods

28 Packing Issues - General Packaging is ALWAYS a key risk area Compounded in IMP Blinded products look identical Labels are the same for all treatments CANNOT easily check afterwards that all operations have been performed correctly Packaging designs can be extremely complex

29 Packing Issues - Labels Requires security of label text submission and printing process Master labels need to have unique code Reconciliation is 100% Sample labels need to be retained Difficult with randomised studies Secure, segregated storage of approved labels needed

30 Packing Issues - Assembly Operations are largely manual Many small orders processed Large variability from one to the next Equipment is very simple Clearance checks are critical Segregation of orders is vital

31 Packing Issues - Documentation Instructions must be approved before use Must give full traceability of activities, people, product, materials Expiry date must be clear expiry dates can be updated if relevant Expiry date of patient pack linked to product with shortest life Issues with re-supplies Documentation retained for trial life + 5 years

32 Regulatory Issues Submissions are made for each study not for a product Approvals are on a country by country basis Need to be aware of the exact regulatory status Not all countries require submissions Some countries require notification only Similar variety with significant amendments EU GMP does not apply to all countries in a study EU GMP not applied consistently across EU member states

33 Regulatory Issues(2) Ongoing Studies Regulatory submissions have not been made in many countries for studies that pre-date the CTD Comparators AZ may wish to use comparators not yet available commercially in the EU Sourcing can be an issue Investigator Sponsored Studies - AZ is more similar to a contractor QP Agreement required CPU based studies may require a CPU facility with a Manufacturer s Licence (IP) as there are no licenced pharmacies for IMP c.f. For commercial product some labelling may be done in a licenced pharmacy.

34 Summary The decision to release product depends on confidence that: people have followed the principles of GMP manufacturing conditions are satisfactory utilities and process equipment are suitable process controls and environmental data (where relevant) is available and measurements are within specified limits production and analytical documentation is completed and properly authorised e.g. batch sheets, labels deviations have been identified and evaluated evidence has been provided to demonstrate compliance with product specifications e.g. by sampling and testing regulatory requirements have been met

35 Solutions? Communication and Training!! Understand the systems and processes operated See and be seen Ear to the ground Create open and trusting environment Know the key personnel Regular meetings Collate and trend any issues Risk Assessment Change Control

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