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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
© QIMR Berghofer Medical Research Institute | 4
Different Standards Reviewed
© QIMR Berghofer Medical Research Institute | 5
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
© QIMR Berghofer Medical Research Institute | 6
Results
© QIMR Berghofer Medical Research Institute | 8
LEGEND
# Standard QMS Applied
** Based on Annex 13 of the PIC/S
Required
X
Not Required
*
Optional
© QIMR Berghofer Medical Research Institute | 9
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
#
© QIMR Berghofer Medical Research Institute | 10
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
Monitoring Systems
Internal
Audits
Auditable Auditable #
Corrective
Actions
#
Customer
Complaints
**
Annex 13 PICS
** #
Recall ** ** #
Security #
Computer
Records
#
© QIMR Berghofer Medical Research Institute | 11
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
Personnel and Training
Training #
Records
Donor Records #
Informed Consent #
Collection Records #
Retrieval Records #
Processing
Records
#
Final Product #
Storage/Retention
and Archiving
#
© QIMR Berghofer Medical Research Institute | 12
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 ** ** #
© QIMR Berghofer Medical Research Institute | 13
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 /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
© QIMR Berghofer Medical Research Institute | 14
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
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
#
© QIMR Berghofer Medical Research Institute | 15
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
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 #
© QIMR Berghofer Medical Research Institute | 16
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
Storage
Labelling #
Quarantine Not
specifically
mentioned
Not
specifically
mentioned
#
Discard Not
specifically
mentioned
Not
specifically
mentioned
#
Packaging
Labelling #
Records #
© QIMR Berghofer Medical Research Institute | 17
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
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
© QIMR Berghofer Medical Research Institute | 18
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
Other Considerations
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
© QIMR Berghofer Medical Research Institute | 19
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
Other Considerations
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
© QIMR Berghofer Medical Research Institute | 20
Common Points
• Established Quality Management System
• Traceability
• Emphasis on patient and product safety
• BUT
• Can be open to interpretation
© QIMR Berghofer Medical Research Institute | 22
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
© QIMR Berghofer Medical Research Institute | 24
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
© QIMR Berghofer Medical Research Institute | 26
• 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 +
© QIMR Berghofer Medical Research Institute | 27
Other Considerations
• Risk Management
– Perception of risk may differ between groups
• Access to unapproved biologics
– different requirements/legislations between
countries
© QIMR Berghofer Medical Research Institute | 29
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.
© QIMR Berghofer Medical Research Institute | 31
• 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.
© QIMR Berghofer Medical Research Institute | 32
Thank you
www.qimrberghofer.edu.au