2012 Joint Guideline Launch

Transcription

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2 Behind the development - CHC s Guideline for Raw Materials

3 Behind the development - ASMI s Good Supplier Practice

4 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.

5 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

6 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

7 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.

8 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.

9 Review and update of the Guidelines & VQQs Will be reviewed on a 3 yearly basis. In this 1 st 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.

10 Benefit to the Suppliers BENEFITS CURRENT SITUATION THE OPPORTUNITY Transparency of requirement/ expectation Business Efficiencies Reduced paper work. Increased quality of paperwork. Improved relationships with principals and with customers. Streamlined vendor approval process. No Specific Guidance for Suppliers 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 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

11 What are the benefits to Sponsors/Manufacturers? BENEFITS CURRENT SITUATION THE OPPORTUNITY Transparency of requirement/ expectation Improved Service from Suppliers Better / Faster turnaround of data. Greater Levels of Quality Assurance. Improved relationships with the Supplier. Streamlined vendor approval process. No Specific Guidance for Suppliers Each Medicine Manufacturer provides their own questionnaire for internal assessment. Each questionnaire is essentially asking very similar questions to obtain the same information. 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. Reduces the cost of poor quality

12 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.

13 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.

14 Questions?