2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
•The CHC’s Raw Material Supplier
Technical Committee and
Manufacturing and GMP
Technical Committee
•ASMI’s Manufacturing Working Group.
•GSP Working Party:
• Michael Gepp (Pathway),
•Cathrine Dahlgren (Xena
Technologies),
•Devlin Gardner (Ensign
Laboratories).
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Overview of the guidelines
1. Guideline for the Quality & Safety of Raw Materials used in Complementary
Medicines (the CHC Guideline for Raw Materials); and
2. Good Supplier Practice (GSP).
Supporting Vendor Qualification Questionnaires - common to both Guidelines
•Supplier Vendor Qualification Questionnaire
•Raw Material Manufacturer Vendor Qualification Questionnaire
•Transmissible Spongiform Encephalopathies (TSE) Questionnaire
•Free From Information Questionnaire
•Packaging Material Manufacturer Vendor Qualification Questionnaire
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Genesis of these guidelines
• CHC and ASMI working independently with slightly different focus.
• Similar aims – contributing to the assurance of quality starting materials.
• Same backdrop of events in the media and issues & risks being managed by
our members.
The CHC - primarily addressing documentation requirements for raw materials
to assist industry in their efforts to certify the quality and safety of raw materials
being used in complementary medicines.
ASMI - addressing the broader issues associated with the supply chain of
starting materials focusing where agents, brokers, distributors, and suppliers
act as an intermediary between the raw material or packaging material
manufacturer and medicine manufacturer.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Early in the development work (2010), it was realised that to
maximise the incentive to Suppliers there was significant benefit
in both associations maintaining & using a single set of Vendor
Qualification Questionnaires.
Late in 2011 it was agreed to collaborate as the guidelines being
developed by each industry association were complementary.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Why develop these guidelines?
• Quality and vendor assurance (VA) of starting materials is currently
the responsibility of medicine manufacturers. Suppliers are often used
to procure materials. Therefore VA is conducted by many medicine
manufacturers ,for the same material from the same manufacturing
site, via the same supplier.
• Little specific guidance is available for local starting material suppliers
to the Australian medicine manufacturing industry. There are few
licensing requirements to set up as a supplier of starting materials.
• A clear opportunity existed to involve suppliers more proactively in the
vendor qualification process.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Is there a benefit to the Suppliers?
BENEFITS
CURRENT SITUATION
Transparency of
No Specific Guidance
requirement/ expectation for Suppliers
Business Efficiencies
 Reduced paper work.
Increased quality of
paperwork.
Improved relationships
with principals and with
customers.
Streamlined vendor
approval process.
•Each medicine
manufacturer provides
their own
questionnaire for
internal assessment.
•Each questionnaire is
essentially asking very
similar questions to
obtain the same
information.
Future Vision
THE OPPORTUNITY
Specific Guidelines Available
for Suppliers
•Provision of an industry wide
agreed format for internal
assessment.
•Significant reduction of site
qualification questionnaires
to be completed.
•Each site qualification
questionnaire can be
maintained, and issued on
request.
 Preferred Supplier Status
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
What are the benefits to Sponsors/Manufacturers?
BENEFITS
CURRENT SITUATION
THE OPPORTUNITY
Transparency of
requirement/ expectation
No Specific Guidance for
Suppliers
Specific Guidelines
Available for Suppliers
Improved Service from
Suppliers
 Better / Faster turnaround
of data.
 Greater Levels of Quality
Assurance.
Improved relationships
with the Supplier.
Streamlined vendor
approval process.
•Each Medicine
Manufacturer provides
their own questionnaire
for internal assessment.
•Each questionnaire is
essentially asking very
similar questions to
obtain the same
information.
•Provision of an Industry
wide agreed format for
internal assessment.
•Significant reduction of
site qualification
questionnaires to be
completed.
•Each Site qualification
questionnaire can be
maintained, and issued
on request.
GUIDELINE FOR RAW MATERIALS
 Reduces the cost of poor quality
2012 Joint Guideline Launch
GOOD SUPPLIER PRACTICE
The Qualification Questionnaires are designed for:
• ease of completion:
• for non-English speaking starting material manufacturers.
Supporting documentation is requested where deemed necessary
for verification purposes.
• in a locked Word document format which can be completed and
maintained electronically.
• ease of use within your existing vendor qualification
system.
• requiring only a cover letter for issue and
• an assessment form for internal review.
• provision of extensive detail to provide insight into the
vendor’s capabilities.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Review and update
The guidelines and supporting questionnaires will be reviewed every three
years. A facility has been established to provide suggestions for changes. If
necessary, urgent/ important amendments can be made outside of the three
year review cycle.
The Request for Change Form is with the Guidelines on the CHC & ASMI
websites and is provided on your epack.
Frequently asked Questions
A list of FAQ’s has been prepared for each Guideline and these are available
on the websites and provided on your epack.
These documents will be living documents and will be updated as questions
are asked.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Launch Plan and Rollout
Stage 1 involving sponsors and medicine manufacturers. (Today)
Stage 2 involving broader roll out to raw material suppliers/brokers and
agents on 22 May 2012.
Speakers will include:
• An OMQ representative speaking on Supplier Qualification and
common deficiencies found at audit.
• ASMI & the CHC’s Overview of the Guidelines
• A range of industry perspectives on the Guidelines
• An expert Industry & TGA Panel
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
To maximise the effectiveness of the launch
We need you to:
1. Start implementing the guidelines within your Vendor
Qualification systems to start gaining the benefits.
2. Invite your local suppliers, agents, distributors, brokers
(RMs and Printed & Primary Packaging) as your guests to
the Stage 2 launch preceded by a Networking lunch. Your
epack contains a standard invitation letter to be put on your
company’s letterhead and personalised to your supplier’s
details.
3. Consider sharing with us your company logo as an
endorsement of the Guideline to include on a slide in the
stage 2 presentation, as an indication of the extent of use.
4. Consider measuring your experiences on implementation
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
SUCCESS?
Achieving the benefits of this vision through the Guidelines
and Questionnaires will require discipline from the Industry:
1. To use the questionnaires as they are without changing
them.
2. To note ideas for change and immediately submit a
completed Request for Change form.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Future Opportunities
•Extend an invitation to other industry associations for use of the Guidelines &
Questionnaires to broaden usage and create greater demand for compliance.
•Development of a product specific raw material master file containing a
summary of the information typically requested by manufacturers, such as pack
size, shelf life, storage conditions, kosher and halal status.
•Sustainability/Ethical procurement questionnaire.
•Encourage suppliers to provide a full vendor assurance package, including
either:
• a material manufacturing site audit, report and closure; or
•TGA GMP clearance or equivalent;
in order to achieve preferred supplier status.
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE
Questions?
2012 Joint Guideline Launch
GUIDELINE FOR RAW MATERIALS
GOOD SUPPLIER PRACTICE