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Quality Risk Management: Excipients - ipecamericas.org

Quality Risk management : Excipients ExcipientFest 2012 Presented by: Londa Ritchey, Director, Supplier Qualification Global Quality Operations pfizer , Inc. Agenda Regulatory Environment Material Quality system Elements On-Going Monitoring Risk management Summary 2 3 Integration of QRM into Material Quality Systems Requirements Note: This is one Pharma User s perspective Today s Focus Why Focus on Ingredients? 4 Regulatory expectations of Ingredient Safety are evolving Distributor WarehouseSupplier-Original MfgPharma production site RepackerSupplier s SuppliersSupplier s Suppliers Capture each material Supply chain to each pharma location Capture each Supplier and Role for each material Each Party in the Supply Channel evaluated against the appropriate Quality standard Increased Regulatory Expectation Capt

Pfizer, Inc. Agenda •Regulatory Environment ... Quality Systems Guidance Management of Outsourced Activities and Purchased Materials- ICH Q10- Section 2.7 (a) Assessing ….the suitability and competence ... EHS risk Document quality agreement or audit refusals Evaluate Quality Issues Notifications coming fro…

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Transcription of Quality Risk Management: Excipients - ipecamericas.org

1 Quality Risk management : Excipients ExcipientFest 2012 Presented by: Londa Ritchey, Director, Supplier Qualification Global Quality Operations pfizer , Inc. Agenda Regulatory Environment Material Quality system Elements On-Going Monitoring Risk management Summary 2 3 Integration of QRM into Material Quality Systems Requirements Note: This is one Pharma User s perspective Today s Focus Why Focus on Ingredients? 4 Regulatory expectations of Ingredient Safety are evolving Distributor WarehouseSupplier-Original MfgPharma production site RepackerSupplier s SuppliersSupplier s Suppliers Capture each material Supply chain to each pharma location Capture each Supplier and Role for each material Each Party in the Supply Channel evaluated against the appropriate Quality standard Increased Regulatory Expectation Capture Material Supply Channels On Site Audits of Material Suppliers Quality Agreements with Critical Material Suppliers Quality Risk management

2 Security of the Supply Channel Material Supply Channel Expectations Quality Systems Guidance management of Outsourced Activities and Purchased Materials- ICH Q10- Section (a) Assessing ..the suitability and competence ..to carry out the activity or provide the material using a defined supply chain ( , audits, material evaluations, qualification); (b) Defining the responsibilities and communication processes for Quality related activities of the involved parties. (c) Monitoring and review of the Quality of the material from the supplier, and the identification and implementation of any needed improvements; (d) Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed supply chain.

3 Quality Risk management - ICH Q9 Material system Elements Evaluation & Approval of Suppliers Evaluation & Approval of Materials Acceptance Criteria Receipt and Inspection Inventory Control Storage Sampling and Testing Retain management Destruction Procedural Controls Training/ Qualification GMP Documentation Investigations Change management Computerized Systems Validation Monitoring CAPA management Review Robust Quality system Pre- Use Use Period Post- Use Core Requirements ICH Q10 Pharma User- Material system Managing Material Sourcing Risks Material Risks Material Precursors Origins of the material BSE/TSE, GMO Allergens, Residual solvents other material source risks Process capability, CQA defined Specificity of test method, Incentive/demand Supplier Risks Primary industry serviced, Pre-audit Quality assessment, Audit rating, Category sourced Country of Mfg Quality History Quality Agreement Open CAPA Control of starting materials Quality Culture Supply Channel Risks Transparency Number of parties in SC Repackaging /Relabeling Tamper Evidence Original Mfg CoA.

4 Other documentation Transportation qualification Associated Parties- direct access 8 Capturing Supply Channels Sub-roles for Processor Each supplier must have a qualification status prior to Approval of Supply Channel Note: The data shown here has been created solely for the purposes of presenting an example and does not reflect confidential supplier data Essential to understanding Material, Supplier and Supply Channel risks Material Qualification 10 Collect and review material risk data Material Sourcing Questionnaires GMP Pre-audit assessment Security Allergens.

5 GMO BSE/TSE Residual Solvents Other General Material Questions Material Supply Channel Survey Know Critical Quality Attributes of Material Understand Process Capability/normal process variability for Material Understand Stability of Material Share Intended Pharmaceutical use with Supplier Qualify material in process and stability system for Material Approval should include review and acceptance of Material Supply Channel Supplier Approval 11 1. Evaluate Pre-Qualification Risk Profile Security Questionnaire Pre-Audit Questionnaire Business intelligence 2.

6 Quality Systems Audit 3. Quality Agreement 4. Risk Control plan for outstanding concerns 5. Document Approval decision 6. Monitor compliance to specifications, QA and MFG standards 7. Complaints/CAPA management and trending 8. Notification management - change, Quality , other 9. Continuous improvement initiatives 10. Supplier Quality Metrics review 11. Re-assessments of supplier status - max. frequency Supplier Audit Considerations Auditor(s) focus on material category and Pre-Qualification Risk Profile Re-audit frequencies based on: Material type On-going risk profile Performance history Document specific Supply Channel management reviews Review Changes since last audit Audit specific role of Supplier in Supply Chain GMP, GDP, GIP Elevate significant findings immediately for management review Update Risk profile and create risk control plan as needed 12 SUPPLY CHAIN SECURITY Is there a supply chain security program/plan?

7 Is there awareness / sensitivity around the importance of supply chain security? Do they have procedures and processes in place to prevent supply chain related adulteration, diversion, and counterfeiting? Are there procedures in place to respond to supply chain related events? Is there a good supplier Quality management program (selection, oversight, etc.) that incorporate supply chain risks? Are there effective processes and databases for supply chain transparency? Do the supplier Quality management principles extend to warehousing and transportation providers?

8 Are any processes in place to gather supply chain related intelligence from the market? Sample Audit Questions-SCS 13 Quality Agreement Considerations Cover the supply channel parties for Ingredient materials with Agreements Agreements with all Distributors and Repackers of Ingredients Template language to include security provisions Define roles/responsibilities/ communication pathways Change notifications, Quality events, etc Subcontractor and supplier controls Approval signifies Acknowledgement that material is used for a pharmaceutical product intended for human consumption.

9 Sample Supply Chain Integrity provisions for agreement Supplier shall utilize tamper evidence packaging. Supplier shall provide identifying information on tamper evidence device(s) as requested. Supplier shall maintain knowledge of the original manufacturers of each critical material used in the production and packaging of Material intended for Customer . Supplier shall Qualify transportation services/carriers contracted by Supplier to distribute Material to customer, as relates to maintaining the Quality and integrity of the Material enroute to Customer.

10 Acceptance Criteria Formal agreement on specifications for materials May be documented in a Quality agreement, specification agreement, or material approval document Critical Quality attributes for materials should be defined based on Use- specifications should include these Change management required for specifications Quality Agreement includes change notification requirements Understand packaging (including tamper evidence) and shipping requirements for materials Retest or expiry dating from Supplier should be justified by data (and documented) 14 15 OBSERVE Keep a general awareness of material drums and package appearance, for example: color, size, closure, label, container markings tamper evidence device If there is a tamper evidence device, is it intact?


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