Global Good Manufacturing Practice - c.ymcdn.comc.ymcdn.com/sites/ · PDF fileGlobal Good Manufacturing Practice – A Comparability Study to Link Good Manufacturing Practice Standards

Global Good Manufacturing Practice –

A Comparability Study to Link Good

Manufacturing Practice Standards for

World Wide Compliance Within the

Cellular Therapy Industry

Presented by Rosemarie Bell

24 April 2014

Overview

• Importance of GMP

• Standards Studied

• Standard Comparisons

• Common Points

• Main Differences

• Stumbling Points

• Other Considerations

• Wish List

© QIMR Berghofer Medical Research Institute | 2

Importance of GMP

In a nutshell….

• Safety to Patient

• Safety of Product

• Consistency

• Continuous Improvement


Different Standards Reviewed


Different Standards

Standards/ Codes/ Guidelines Reviewed So Far

Pic/s Guide to GMP

Australian Code of Good Manufacturing Practice- Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Trials –Therapeutic Goods Administration (TGA)

Australian Regulatory Guidelines for Biologicals – (TGA)

Unapproved Therapeutic Goods – TGA

‘In Vitro Diagnostic Medical Devices” – TGA

Clinical Trial Handbook – TGA

References ICH Guidelines

EMEA Guidelines

Standards/ Codes/ Guidelines under Review Ongoing

International Conference on Harmonization Guidelines (ICH)

European Medicines Agency (EMEA) Guidelines

Committee for Proprietary Medicinal Product (CPMP)

Federal Drug Administration (FDA) Guidelines


Results


LEGEND

# Standard QMS Applied

** Based on Annex 13 of the PIC/S

Required

X

Not Required

*

Optional


Good Manufacturing Practice – Standards Comparison Performed to Date

Requirement

Standard

PIC/S Guide

to Good

Manufacturing

Practice

Australian Code

of GMP for

Blood, Tissues

and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices

Organisational

Structure

Management

Review

Quality System Requirements

Documentation

Written

accounts of

Clinical Trial

Products

required

Written

accounts of

Clinical Trial

Products

required

#

(STD QMS

applied)

Change

Control

Protocol

Amendment

Protocol

Amendment

#

Document

Control

#

Document

Storage and

Retention/

Confidentiality

#



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian Code

of GMP for

Blood, Tissues

and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices

Monitoring Systems

Internal

Audits

Auditable Auditable #

Corrective

Actions

#

Customer

Complaints

**

Annex 13 PICS

** #

Recall ** ** #

Security #

Computer

Records

#



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian

Code of GMP

for Blood,

Tissues and

Human CTPs

(TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices

Personnel and Training

Training #

Records

Donor Records #

Informed Consent #

Collection Records #

Retrieval Records #

Processing

Records

#

Final Product #

Storage/Retention

and Archiving

#


Requirement

Standard

PIC/S Guide

to Good

Manufacturing

Practice

Australian Code

of GMP for

Blood, Tissues

and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices

Buildings and Facilities

Environmental

Control

** ** #

Floors, Walls and

Ceilings

** ** #

Cleaning ** ** #

Goods Receipt ** ** #

Storage Areas ** ** #

Manufacturing

Areas

** ** #

Donor Areas ** ** #

Despatch ** ** #



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian Code

of GMP for

Blood, Tissues

and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /with

reference to ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices

Equipment

Qualification

and

Validation

Not specifically

mentioned put

falls under

GMP principles

statement

outlined in

Annex 13 of

the PIC/S

Not specifically

mentioned put

falls under

GMP principles

statement in

Annex 13 of

the PIC/S

#

Preventative

Maintenance

#

Calibration

and

Validation

#

Refrigeration

Equipment

#

Cleaning of

Equipment



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian Code

of GMP for

Blood, Tissues

and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices

Control of Material

Suppliers #

Contractors Contract

research

organisations

Contract

research

organisations

#

Reagents #

Collection

Packs

collection

kits

#

Labels ** ** #

In process

and critical

material

#

Non

conforming

Material

#



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian

Code of GMP

for Blood,

Tissues and

Human CTPs

(TGA)

Clinical Trial

Handbook/

GCP Guidance

/ICH /EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical

Devices

Donor Selection, Donation and Testing

Pre – Donation Select

donors on

suitability

Select

donors on

suitability

#

Donation #

Post Donation #

Testing of Donor

Samples

Not

specifically

mentioned

Not

specifically

mentioned

#

Medical Director

involvement

Not

specifically

mentioned

Process Control

Validation Based on

GMP

principles of

the PIC/S

Based on

GMP

principles of

the PIC/S

Monitoring #

Release #



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian

Code of GMP

for Blood,

Tissues and

Human CTPs

(TGA)

Clinical Trial

Handbook/

GCP Guidance

/ICH /EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical

Devices

Storage

Labelling #

Quarantine Not

specifically

mentioned

Not

specifically

mentioned

#

Discard Not

specifically

mentioned

Not

specifically

mentioned

#

Packaging

Labelling #

Records #



Requirement

Standard

PIC/S Guide

to Good

Manufacturing

Practice

Australian Code of

GMP for Blood,

Tissues and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro Diagnostic

Medical Devices

Transport

Transport

Procedure

#

Release

Release

Procedures

Documentation

requirements

and PIC/S Annex

13

Release criteria

required as well

Documentation

requirements

and PIC/S Annex

13

#

Adverse Events

Procedures

#

Other Considerations

HREC

Committee

Master Files Site

Master File

Technical

Master File

Trial Master File Technical Master

File under GMP

Trial Master File TMF as part of

QMS STD – the

detail is

determined by

the Class of IVD.

Not mentioned



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian Code

of GMP for

Blood, Tissues

and Human

CTPs (TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA

Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro Diagnostic

Medical Devices


Investigator

Brochure

x X Exempt if not

included on

ARTG under

CTN, CTX

scheme

x

x

Deviation from

Statistical Plan

x X X x

x

Reference to

other Codes /

Standards

Council of

Europe

Guidelines for

the Selection of

Donors

Reference to

Annex 13 of

PIC/s

ISO, ICH, EMEA

Stds

CPMP/ICH/1

35/95

OSP 14155,

Reference

to Annex 13

of the PIC/S

Therapeutic

Goods Act 1989,

Therapeutic

Goods (Medical

Devices)

Regulations 2002

ISO 15189

ISO 13485

Designed to reflect

the PIC/S



Requirement

Standard

PIC/S Guide to

Good

Manufacturing

Practice

Australian Code

of GMP for Blood,

Tissues and

Human CTPs

(TGA)

Clinical Trial

Handbook/ GCP

Guidance /ICH

/EMEA Guidelines

Australian

Regulatory

Guidelines for

Biologicals

Unapproved

Therapeutic

Goods - TGA

In Vitro

Diagnostic

Medical Devices


Other

Considerations

CTN / CTX scheme

allows non ARTG

registered goods

to be supplied to

the public as part

of Clinical Trial.

Refers to CTN

and CTX

Schemes for

Clinical Trials

Generally based

on a risk

management

approach

Specific criteria

for products fall

under this Code

Covers

Infectious

Disease

screening in

more detail

Covers donor

evaluation in

more detail.

CTN/CTX scheme

allows non ARTG

registered goods

to be supplied to

the public as part

of a Clinical Trial

– Special Access

Schemes

IVD Medical

Devices are

classified as

Class 1,2,3,4

pending on the

health risk to the

public.

Conformity

Assessment

includes a QMS

and design,

manufacturing,

risk analysis,

clinical evidence

and ongoing

monitoring

documentation.

Still Going With ……

• FDA Guidelines

• EMEA Guidelines

• ICH Guidelines

• Plus – other guidelines

The list is endless


Common Points

• Established Quality Management System

• Traceability

• Emphasis on patient and product safety

• BUT

• Can be open to interpretation


Main Differences

• Dependant on product type or clinical trial

phase.

• Infectious Disease Screening Requirements

(IDS either side of collection/ 180 day follow

up for HBV , NAT )

• Process Validation Requirements

• Risk Management


Stumbling Blocks

• Requirements to conduct Clinical Trials from

Phase I differ between countries

• Release criteria – may be different

• IDS – may need to be performed by licensed

Laboratories (i.e. TGA licensed)

• Validation of process prior to commencement

of manufacture – differs between

manufactured product and clinical trial


• Obtaining sponsorship to manufacture

• Time taken to implement Standard and

acquire licence - at least 1-2 years

• Cost factor- can be prohibitive – starts at

$100k +



• Risk Management

– Perception of risk may differ between groups

• Access to unapproved biologics

– different requirements/legislations between

countries


Wish List

• To achieve a global harmonization standard

that is easy to understand, easy to follow,

providing a progressive approach to

achieving GMP compliance, while allowing

room for continuous improvement.

• Recognition for Companies licensed by

equivalent Standards.


• While there are differences between the

Standards, GMP Standards are similar and a

robust global Standard harmonisation is

achievable if all have one common goal –

product safely produced in accordance with

standardised good manufacturing practice.


Thank you

www.qimrberghofer.edu.au

Documents

Global Good Manufacturing Practice - c.ymcdn.comc.ymcdn.com/sites/ · PDF fileGlobal Good Manufacturing Practice – A Comparability Study to Link Good Manufacturing Practice Standards