2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Behind the development - CHC’s Guideline for Raw Materials

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Behind the development - ASMI’s Good Supplier Practice

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Why develop these guidelines?

• Quality of starting materials and vendor assurance (VA) of starting

materials is currently the responsibility of medicine manufacturers.

•In Australia 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.

•A clear opportunity existed to involve suppliers more proactively in the vendor

assurance process.

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

a) Supplier Vendor Qualification Questionnaire

b) Raw Material Manufacturer Vendor Qualification Questionnaire

•Transmissible Spongiform Encephalopathies (TSE) Questionnaire

•Questionnaire regarding Free From Information

c) Packaging Material Manufacturer Vendor Qualification Questionnaire

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Where is the benefit?

• Both associations maintaining & using a single set of Vendor

Qualification Questionnaires.

• ASMI/CHC commitment to work together to review and update

the Vendor Qualification Questionnaires

• The Design of the VQQ forms.

• All users (Suppliers, Manufactures and Sponsors, members

and non members) invited to contribute to the continual

improvement, ensure the relevance and the functionality of the document to the industry. - Request for Change Form

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS 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

Responsibilities for maintenance and issue of

VQQs:

• Completed Questionnaires should be amended as change

occurs to the detail of the site, or at least every 3 years. i.e.

it will be deemed to have expired after 3 years.

• Revised Questionnaires should be issued to all customers

who were issued the original Questionnaire.

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Review and update of the Guidelines & VQQs

• Will be reviewed on a 3 yearly basis.

• In this 1st year of operation we will schedule a review after 12 months.

• A facility has been established to provide requests for changes.

• Where 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.

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Benefit to the Suppliers

BENEFITS CURRENT SITUATION THE OPPORTUNITY

Transparency of requirement/ expectation

No Specific Guidance for Suppliers

Specific Guidelines Available 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.

•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 Future Vision

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.

Reduces the cost of poor quality

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS GOOD SUPPLIER PRACTICE

Rules for Success

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.

Frequently asked Questions

• A list of FAQ’s has been prepared for each

Guideline and these are available on the

websites.

• 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

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.

•Encouragement of 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?