Hu Bin_EN

nullQuality Assurance in Contract OperationQuality Assurance in Contract OperationHu Bin Pfizer SuzhouContentsContentsInevitability of Contract Operation Quality Assurance to Contractor OperationnullGlobal Drug Market Grow Up in SlowlyGlobal Drug Market Grow Up in SlowlyNegative Profit Grow up in Some companyNegative Profit Grow up in Some companyOff Patent Effect on Product ProfitOff Patent Effect on Product ProfitContract Operation-Emerging MarketContract Operation-Emerging MarketDeal Structure in Contract OperationDeal Structure in Contract OperationHas the promotion, marketing or distribution agreement with the contractor, with no company’s labeling. Has the promotion, marketing or distribution agreement with the contractor, with company’s labeling. The company acquires a company, division, or expansive product portfolia. Joint Ventures. Contract Process FlowContract Process FlowQuality Responsibility in Each StageQuality Responsibility in Each Stage1st stage: Exploration (Feasibility Assessment) Purpose 1: Determine the scope of the initiative to identify the appropriate Quality resources needed to support the initiative. Purpose 2: Determine if the potential contractor meets the Quality Minimum Acceptance Criteria. Quality Responsibility in Each StageQuality Responsibility in Each Stage1st stage: Exploration (Feasibility Assessment) Evaluate the potential contractor against the Quality Minimum Acceptance Criteria. Conduct a brief site visit by a cross-functional team for high value or strategic initiatives. Quality Responsibility in Each StageQuality Responsibility in Each Stage2nd stage: Evaluation & Selection (Quality Due Diligence/DD) Conduct DD and evaluation Identify issues that may affect the deal value or result in unexpected future liabilities Evaluate and prioritize potential issues and risks Enable informed business decisions Definition of DDDefinition of DD The evaluation process to critically investigate the quality, technical, compliance, EHS, and capacity etc. of a potential contractor. Conclusion: Acceptable Conditionally Acceptable Not Acceptable nullLevel of DD based on Deal StructureLevel of DD based on Deal StructureLevel of DD based on Product Portfolio & MarketsLevel of DD based on Product Portfolio & MarketsLevel of DD based on Contractor & Supply ChainLevel of DD based on Contractor & Supply ChainKey point of DDKey point of DDDD audit is actually review & evaluate the quality culture based on GMPs regulations. Quality culture Organization culture Supply chain security culture Other considerationsQuality Responsibility in Each StageQuality Responsibility in Each Stage3rd stage: Qualification All significant quality or compliance risks should be mitigated before product launch. Development of a Qualification Plan including the mitigation plan, and quality related costs & recourses needed to mitigate the risks. If needed, establish governance structure, usually applicable for high value products or joint ventures. Quality Responsibility in Each StageQuality Responsibility in Each Stage4th stage: Agreement Supply agreement Quality agreement Specified each party’s responsibility in production operation & quality control in detail. Quality Responsibility in Each StageQuality Responsibility in Each Stage5th stage: Commercialization Readiness Process validation Stability study Master production records Test plan of target products Quality specifications & acceptance criteria Approval of controlled documents Quality Responsibility in Each StageQuality Responsibility in Each Stage6th stage: Product Launch Establish internal quality system based on deal structure Clarify the logistics route for final goods Clarify the information route for product complaint, ADE etc. Quality Responsibility in Each StageQuality Responsibility in Each Stage7th stage: On-going QAQuality Responsibility in Each StageQuality Responsibility in Each Stage7th stage: On-going QA Periodical visit Regulatory inspection Serious deviation Significant quality complaint Serious ADEQuality Responsibility in Each StageQuality Responsibility in Each StageQuality visits based on product quality risk Periodical Visit to Current ContractorPeriodical Visit to Current ContractorThe agenda can include but not limited to below: Quality management review: deviation, CAPA, complaint, environment monitoring, regulatory inspection etc. GMP system familiarization & area tour: document review, real-time review of executed batch records Current quality issues: audit follow-up, OOS investigation etc.Periodical Visit ReportPeriodical Visit ReportIssue visit summary within 30 days of completion of visit. At least includes below: The topics reviewed Significant quality risks identified if any Actions identified to mitigate risk Assessment of the overall quality risk profilenull