Launch of
IPEC/PQG
Excipient GMPs
guide
Kevin McGlue, Steve Moss
IPEC/PQG Excipient GMPs guide
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The organisations
Background
Key milestones
Joint charter (governance and oversight)
Development process
Major improvements
Benefits to Industry and Regulators
Implementation Strategy
IPEC
• International Pharmaceutical Excipients
Council
• Formed in 1991 by manufacturers and endusers of excipients
• Three associations covering the US, Europe
and Japan
• Objective: to contribute to the development
and harmonisation of international excipient
standards, the introduction of useful new
excipients to the marketplace and the
development of good manufacturing practice
for excipients.
• First published GMP Guide for Bulk
Pharmaceutical Excipients in 1995, revised
in 2001 to align with ISO 9001:2000.
PQG
• Institute of Quality Assurance, Pharmaceutical
Quality Group
• Formed in UK in1977
• Key objective: To promote the development of
a consistent approach to pharmaceutical
quality and good manufacturing practice.
• In 1990 published three codes of practice pharmaceutical raw materials, printed and
contact packaging materials. In 1995 revised
and integrated these with ISO 9002:1994.
• Raw materials code revised and reissued as
PS 9100:2002 Pharmaceutical excipients, an
application standard and GMP guide for
pharmaceutical excipients.
Background to the joint guide
• Increased focus on Excipient GMPs led to
the need for a single international guide
• June 2002
– IPEC Europe, IPEC Americas and PQG
signed a letter of intent in committing to
collaborate on a Baseline GMP guide for
excipients
• December 2002
– Joint charter issued
Joint Charter – Purpose
• To produce a joint international GMP guide for
excipients, which will build upon and replace the two
groups’ existing documents. It will be aligned to ISO
9001:2000 and include a baseline (minimum) GMP for
excipients.
• During development of the document excipients used in
more critical applications will be considered for inclusion
in Appendices, as appropriate
• The document will also provide the basis for a
certification scheme for excipient suppliers separate from
the basic GMP guideline.
Joint Charter - Boundaries
• Includes:
– GMP guide for excipients for all pharmaceutical
products
– GMP guide could be used for certification in
subsequent phase
– Future inclusions include audit and training guides
• Excludes:
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Sterile excipients
Active Pharmaceutical Ingredients
Products of biotechnology
Certification process
Joint Charter - Structure
• Steering Committee (Sponsors):
– 2 Members IPEC-Europe
– 2 Members IPEC-Americas
– 2 Members PQG
• Team Members (Core team):
– Six members, two from each organisation
Joint Charter – Some Stakeholders 1
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Association of the British Pharmaceutical Industry,
CEFIC,
Certification bodies for PQG Scheme,
European Federation of Pharmaceutical Industry
Associations,
Excipient suppliers,
European Community DG3,
European Pharmacopoeia,
International Conference on Harmonisation,
IPEC-Europe, IPEC-Americas,
International Pharmaceutical Excipients Auditing Inc
(IPEA),
Joint Charter – Some Stakeholders 2
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Institute of Quality Assurance
PQG committee,
Pharmaceutical companies,
Pharmaceutical Research and Manufacturers of America
(PhRMA),
Regulatory bodies (Food & Drug Administration,
Medicines & Healthcare Products Regulatory Authority
etc),
United States Pharmacopoeia,
World Health Organisation,
Japanese Pharmaceutical Excipients Council (JPEC) as an observer
Key milestones
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Initial meeting
Review process
Draft new guide
Consultations and review
Final review
Publication and launch
Initial team meeting
23rd January 2003
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Key principles
Project timescales
ISO 9001 format
Overall document structure
Consultation and review process
Initial review process
Started March 2003
• Reviewed detail of key source documents
– PQG, IPEC, ISO 9001, ICH Q7a
• Compared all the clauses in a matrix
• Chose the most appropriate guidance
appropriate for excipients
• Resolved differences
• Significant update in line with current thinking
• Involved careful consideration and deliberation
Drafted NEW guide
Q2 2003 to Q1 2004
• Improved assignment to ISO sections
– more logical flow and improved readability
• Key areas improved with significant rewriting
include:
– structure & responsibility of quality unit, product
release, validation, stability, change control,
GMP principles, auditing considerations
• “Continuous processing” accounted for throughout
– E.g. bulk materials, batch documentation and
release
Further development of guide
Q2 to Q3 2004
• Many multi-day meetings in UK, US, France
• Continual adaptation to the prevailing changing
environment
• Maintained focus on developing voluntary
baseline guidance
– Potentially with need for additional guidance
for specialist applications
Consultation and review
Q4 2004 to Q3 2005
1. Members comment x2 (some external bodies eg
EFPIA via members)
– Consolidated comments (100’s!) to produce approved draft for
external release
2. External circulation - Key organisations including
regulatory authorities, trade organisations and other
stakeholders
– Consolidated comments
3. Issued to members for final comment
– Consolidated comments to produce final draft
4. Comprehensive QC checks x2 teams
– Corrected to produce draft for printing
Publication & printing
Q4 2005
Hardcopy
• US English by IPEC Americas
– letter and pocket versions
• UK English by IPEC Europe
– A4 and pocket versions
Electronic
• A4/letter downloadable from websites
Thanks to the
GMP/Partners groups
and the wider
membership of each
organisation for help and
excellent contributions!
Major improvements 1
• Better assignment to ISO sections to give
more logical flow and improved readability
• Accurate and legible wording
• Appropriate guidance for excipients
• Key ‘awkward clauses’ addressed e.g.
stability, validation, change control
• Included continuous processing particularly the impact on batch definition
and records
Major improvements 2
• Improved auditing considerations - GMP
principles and applications
• Harmonized glossary - rationalised to ICH
where possible
• Consistent use of terminology e.g.
document, records; rework, reprocess
• Removed ambiguity for international use
(e.g. recall/retrieval; batch/lot)
Benefits to Industry and Regulators
1. Broad acceptance
• Document critically reviewed by all
stakeholders to obtain consensus
• Well received by excipients industry and
by pharmaceutical companies and their
industry bodies, regulators EMEA and EC
- suggests balance is appropriate
• Overall good collaboration between US
and Europe resulting in international
acceptance
Benefits to Industry and Regulators
1. Broad acceptance (cont’d)
• Participation and involvement with many
good comments from many members,
organisations, etc
• Working with EC - new guide helping
focus discussions and benchmarking
appropriate principles which may become
law for certain excipients
Benefits to Industry and Regulators
2. Ease of application
• Builds additional GMP guidance onto the ISO
framework
– commonly used by the industry already
• Practical guidance for excipient manufacturer
– balancing pharmaceutical customers'
expectations with usual constraints
• Clear unambiguous wording
Benefits to Industry and Regulators
2. Ease of application (cont’d)
• Provides common guide eliminating the need for
multiple customers' requirements.
– Manufacturer – applies common & appropriate
standard, quality systems & controls
– User – provides common expectation of what is
appropriate for excipient manufacturers, audits
• Clearly differentiates guidance for excipients
– more than ISO 9001
– more appropriate than ICH Q7a
Implementation Strategy
• Launch events
– IPEC Americas – Orlando, 26th January 2006
– PQG – London, 7th February 2006
– IPEC Europe – Cannes, 9th February 2006
Additional copies available now
• ipec.org and
pqg.org
– Order forms for printed
copies
– Members download
free
• Please spread the
word!