A Quality Auditor’s Perspective of Starting Material Manufacturers & Suppliers Cathrine Dahlgren

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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Observations of an Auditor  Vendor Assurance - an investment for reducing your cost of poor quality overall.  Suppliers have a role in Australia to facilitate access to starting materials in small quantities.  Few suppliers actually conduct physical audits on their starting material manufacturers to ascertain the Quality, Identity, Safety, Purity and Efficacy.  Australian finished product manufacturers each conduct their own Vendor Assurance for the starting materials required for production. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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 The steps undertaken include:  Sample Assessment and technical information  Paper audit to assess Quality systems at the site of manufacture.  Physical audit if deemed by Risk Assessment to be of a high risk category to the business. Ie. expensive ingredient, large volumes, affecting many products etc.  Risk of information provided being “REAL”  Audit of the Supplier to assess Quality systems are in place. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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Cost Effectiveness – Understanding exactly what you are getting

Attractive Competitive Cost of Materials

Risk of Cost of Quality

Vendor Assurance

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

GOOD SUPPLIER PRACTICE

What do I see at Audit ? 1. Starting Material Manufacturers:

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Raw Materials

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Packaging Materials

2. Suppliers

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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Raw Material Manufacturers 1. Vitamin Manufacturing Facility in Asia Production containing Pyridine occurred in same vessel with no cleaning let alone validation of cleaning between products.

Dog laying in doorway to facility during production. ISO 9001 certification purchased by Marketing Department.

No SOP’s or batch manufacturing directions or records.

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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2.

Amino Acid Manufacturing Facility in Asia

Production capacity quoted as 1000 tonnes per year Production batch documentation only 24 tonnes per year.

Product in back shed under tarps – Traders Re-badging and relabelling of stock to be their own.

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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3. Herbal Extract Manufacturing Facilities in Asia    

Facility appearance - well maintained. No raw material stock (herbal) to be seen. Advised that 80% product range was made on this site. Apparent after auditing the QC testing facility that only 20% of product range was manufactured on site.  Balance of range - traded goods relabelled as own brand.  On audit of those herbal manufacturers it became apparent that the site was for ‘display’ purposes.  Not evident until physical audit conducted.

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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Packaging Component Manufacturers Deficiencies seen at audit:

 Lack of process controls on critical specifications to the manufacture of packaging components.  ISO 9001 certification purchased by overseas companies.  Vendor Assurance Questionnaires providing all the right answers but when physically audited – Production & QA Systems not evident. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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EXAMPLES 1. Amber Glass Tablet bottles Issue: breaking whilst Jcap being applied on line. Investigation showed:  no change to packing line set up or cap.  Manufacturer had changed manufacturing site with out advice.  The quality systems at the new site were not providing consistent manufacturing of the glass bottles which caused inconsistencies in the thickness of the glass. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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2. Splitting of Polyethylene caps applied to bottles during transportation.  No Change to the lid specification evident at routine QC testing.  Manufacturer had varied the specification of the lid in production.  Slight reductions to Diameter of the lid and the thickness of material - but was not evident.  Manufacturer’s change control systems were not being adequately managed and not advising clients of changes made to production processes which may impact on their product. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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Starting Material Suppliers Deficiencies Seen at Audit:  Lack of traceability of the material through the supply chain - manufacturing facility through to finished product manufacturer.  Materials purchased by the Supplier and on-sold without sighting or confirming the source/ manufacturing facility.  Suppliers completing the Vendor Assurance questionnaire if the starting material manufacturer is not responsive or unable to complete it. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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 Raw Material Suppliers without a GMP License conducting repackaging.  Sampling of ingredients conducted in warehouse environment or in some instances outside the warehouse environment.  Storage conditions not always appropriate for materials being stored.  Rework and reprocessing of batches to meet specification requirements conducted by suppliers.

2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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EXAMPLES 1. Supplier of peppermint oil drums.  decanting from a drum outside a storage shed into smaller containers &  relabelling with contents. 2. Supplier of amber glass tablet bottles.  storing in a shed, roller doors open at all times.  access to bird life via louvered windows  faecal contamination of shrink-wrapped bottles stored with the top up – tears in plastic wrapping. 2012 Joint Guideline Launch GUIDELINE FOR RAW MATERIALS

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An Opportunity  To protect and grow our businesses we all desire to supply quality products to our customers.  Suppliers could consider  Value adding to the process to reduce or remove the need for the duplication of multiple finished product manufacturers conducting audits on overseas manufacturers.  Amortising the cost of these audits per country and over the relevant clients using the materials.  Or encourage API Manufacturers to obtain TGA Certification. 2012 Joint Guideline Launch

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