Overview of TGAs Involvement in the International Regulatory - - PowerPoint PPT Presentation

Overview of TGA’s Involvement in the International Regulatory Environment

Jenny Hantzinikolas Director, Inspections Section , Manufacturing Quality Branch Medical Devices and Product Quality Division, TGA GMP Forum - 26 June 2018

Overview

• International Harmonisation
• PIC/S activities

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International Harmonisation

International harmonisation of standards and inspections allows for a shared workload with regulators in other countries.

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International Harmonisation

We have been doing this via:

• joint inspections with overseas partners
• shared inspection scheduling
• sharing of information - reports and manufacturer information
• Mutual recognition of codes of GMP and standards

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International Harmonisation

It is made difficult by:

• different regulations on the standards expected in different countries
• different powers in the ability of regulators to access sites
• sharing information and what information is allowed to be shared between

countries

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International Harmonisation

TGA involvement includes

• PIC/S reassessments of existing PIC/S members
• Assessments of proposed PIC/S members
• Joint inspections with MHRA, USFDA, Health Canada, HPRA
• Shared information under confidentiality agreements with PIC/S members

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International Harmonisation

• TGA has provided training to various regulatory agencies e.g. Medsafe, ThaiFDA

and USFDA.

• TGA successfully hosted the Expert Circle on APIs in 2017
• TGA has been involved in PIC/S drafting groups

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International Harmonisation

• Inspector working group involvement in EMA
• Reviews and inputs into revisions developed for PIC/S Guide to GMP

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What is PIC/S?

• A non-binding co-operative arrangement between Regulatory Authorities in the

field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

• It is open to any Authority having a comparable GMP inspection system.

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PIC/S update

On 1 January 2018, PIC/S comprised 52 Participating Authorities from all continents.

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PIC/S

PIC/S’ mission is “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products”.

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PIC/S

Achieving this mission by

• Harmonising inspection procedures worldwide, by developing common standards

in the field of GMP,

• providing training opportunities to inspectors facilitating co-operation and

networking between competent authorities, regional and international

• rganisations, thus increasing mutual confidence.

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PIC/S committee structure

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An insight into PIC/S activities

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Sub-Committee on the Harmonisation of GM(D)P (SCH)

The mandate of the Sub-Committee is

• to harmonise GMP, establish best inspection practices and
• harmonise the interpretation of GMP to ensure consistency in inspection / audit

practices.

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Sub-Committee on the Harmonisation of GM(D)P (SCH)

• The TGA is the deputy chair and EMA IWG liaison
• Revision of PICS chapters /annexes and guidance is discussed/approved at the

subcommittee

• Updates on working group mandate is provided
• Decisions are made on the way forward

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Sub-Committee on Budget, Risk & Audit (SCB)

• The TGA is member
• Assess regulatory risk, financial risk, reputational risk and risk management and

make proposals / recommendation to minimize such risk

• Establish a budget proposal to the PIC/S Committee
• Maintain internal financial control and examine financial transactions

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Data Integrity

TGA is a co chair of the working group

• The working group has developed a PIC/S data integrity guidance document for

inspectors to provide them with the basic skills for performing data integrity inspections.

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Data Integrity

The Working Group has also developed other data integrity guidance tools for inspectors such as an aide-memoire, flowchart to assist inspectors, and system specific guidance.

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Harmonisation of the classification of deficiencies

• TGA is the Chair
• The working group has drafted a guidance document, which includes a tool for

Inspectorates to improve harmonised risk classification of GMP deficiencies.

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Harmonisation of the classification of deficiencies

• Recommendations to facilitate harmonised compliance and enforcement

approaches to address GMP non-compliance are also included.

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Working Group on Annex 1 / Sterile Manufacturing

• TGA is a member of this working group
• Update to the Annex 1 to include up to date processes and technologies
• Currently all comments from the public consultation are being reviewed by the

working group.

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Working Group on Annex 2 / Biologics & ATMP

• TGA is the Chair of this working group
• Update to the Annex 2 and creation of a dedicated Annex for ATMP
• Identify areas of GMP applicable to ATMP that may benefit from modernization

to reflect the current status of the manufacturing processes and manufacturing settings

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Expert Circle on APIs

• TGA is a co chair of this working group
• Provides training to regulators through its seminars
• Update to guidance as required

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Expert Circle on Human Blood, Tissues, Cells and ATMPs

• TGA is a member of the coordinating committee of this working group
• Provides training to regulators through its seminars
• The Expert Circle is developing a number of PIC/S guidance documents

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Cross contamination in shared facilities

• TGA is a member of this working group
• Developed an Aide Memoire to

– harmonise and standardise terminology used in relation with the control of cross-contamination in shared facilities. – address questions which inspectors should ask themselves during inspections in particular in relation with risk management.

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Other PIC/S activities

TGA is also involved in § The drafting of the new ATMP annex § The drafting of the product defect and adverse event procedure

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Other PIC/S activities

TGA is also involved in § Travel security working group § Automated systems working group § Good Clinical Practice working group

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Summary

This has been a snapshot of what the TGA is involved in terms of international harmonisation inclusive of some of the PIC/S activities.

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