Oursourcing and Supplier Qualification from the perspective of the pharmaceutical Industry

Transcription

1 Oursourcing and Supplier Qualification from the perspective of the pharmaceutical Industry 1

2 Presentation Outline Pharmaceutical Quality Management Partner Selection and Qualification Shipping Qualification

3 Pharmaceutical Quality Management The world is changing The area of quality management is undergoing a significant change in the pharmaceutical industry: spotlight is falling on the PQS (Pharmaceutical Quality System) drive for efficiency within companies modern science and risk-based thinking and guidances (e.g. ICH Q8/9/10) increased inspection findings

4 Pharmaceutical Quality Management It s not only about the GxP s GMP is only a part of the lifecycle of a medicinal product and only a part of an overall effective Pharmaceutical Quality Management System. Other quality standards are: ISO 9000 ISO 9000 series on general Quality Management ISO 1348 ISO 13485/21CFR820 for Medical Devices ICH Q10 ICH Q10 defining a Pharmaceutical Quality System

5 Pharmaceutical Quality Management How the regulators see it Quality assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of the product. It is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use Quality assurance therefore use incorporates GMP plus other factors outside the scope of the GMP Guide. Formalised business practices that define management responsibilities for organisational structure, processes, procedures and resources needed to fulfil product/service requirements, customer satisfaction and continual improvement.

6 Pharmaceutical Quality Management Design of a state-of-the-art QMS A Quality Management System has always to look at the big picture. It is the sum of all the management arrangements and the top management s total approach to quality. PLAN: what they need to do DO: what they need to do CHECK: that it has been done correctly ACT: on the information and results to improve the way it does things

7 Pharmaceutical Quality Management Where are we currently? Evolution of regional GMPs 1970s Evolution of ISO 9000 approaches 1980s FDA 21st Century initiative 2002 ICH Quality Vision / Q8, Q9, Q FDA Quality Systems guide 2006 ICH Q10 Pharmaceutical Quality System 2008

8 Pharmaceutical Quality Management Purpose of ICH Q10 ICH Q10 aims to promote a paradigm shift from discrete GMP compliance procedures at each stage of the product lifecycle to a comprehensive quality systems approach over the lifecycle of the product. The objective is to achieve product realization establish and maintain a state of control facilitate continual improvement.

9 Pharmaceutical Quality Management ICH Q10 and GMP s how do they go together? ICH Q10 will expand existing GMPs with specific PQS elements and management responsibilities. encourage science and risk based approaches be used together with existing GMPs cover all stages of the product lifecycle as defined (beyond GMPs).

10 Pharmaceutical Quality Management What are the key elements? GMP ISO 9000 ICH Q10 GMP s Management Responsibility Continual Improvement Knowledge Management Quality Risk Management Lifecycle Approach Opportunities

11 Pharmaceutical Quality Management Just another view

12 Pharmaceutical Quality Management Just another view

13 Pharmaceutical Quality Management Risk Management (ICH Q9) The two primary principles: 1. The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. 2. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.

14 Pharmaceutical Quality Management Risk Management (ICH Q9) Quality risk management process Risk assessment Risk control Risk communication Risk review A robust process will incorporate consideration of all the elements at an appropriate level of detail.

15 Presentation Outline Pharmaceutical Quality Management Partner Selection and Qualification Shipping Qualification

16 Partner selection and qualification Stepwise approach 1. Define selection parameters 2. Establish weighting criteria for selection parameters 3. Gather information from LSP s via questionnaire 4. Rate LSP on selection parameters 5. Calculate overall weighted score and overall rank 6. Generate short-list of candidates 7. Perform evaluation audit(s) 8. Appoint LSP

17 Partner selection and qualification Definition of selection parameters (extract) Selection Parameter Description Scoring criteria Compliance Certification (SQAS, ISO 9001/14001, CT-PAT, CEP, GxP)* Certificate Pharma reference customers # of references Competency Cold Chain, DGR/ADR, Psychotropics # of accounts Customs Own vs. contracted agencies Dedicated pharma organization Type of setup QMS available & implemented in organization Dedicated, shared, none Commercial Offer Completeness of offer # of covered routes Quality of data received 1 to 10 Range of possible services # of service modes Management by KPIs Existing, planned, no Implementation & Development Implementation readyness Timeframe IT Compatibility Full, partly, no Track & Trace Capabilities / Milestone reporting Own tool, outsourced, none Innovation / Drive to change 1 to 10 Company Size Turnover Global Network # of sites Financial situation Profitable, break-even, non-profitable *SQAS =(Safety & Quality Assessment System), CT-PAT=Customs Trade Partnership Against Terrorism, CEP=Certified Environmental Professional

18 Partner selection and qualification Gather information via questionnaire *SQAS =(Safety & Quality Assessment System), CT-PAT=Customs Trade Partnership Against Terrorism, CEP=Certified Environmental Professional

19 Partner selection and qualification Establish weighting factors Score 1-10 (10 highest) Scoring Selection Criteria Overall Weighting Compliance No Partial Yes 35% Commercial Offer No Partial Yes 30% Implementation / Future Development No Partial Yes 20% Company No Partial Yes 15% Total 100%

20 Partner selection and qualification Weighted score and overall rank

21 Partner selection and qualification Perform evaluation audit Audit shall be carried out at both headquarters and branch office Involve contracted GHA s* as well Main observations are Lack of training Missing/incomplete documentation No/not adequate change control No process for deviation handling Non-qualified premises (for GHA s) Establish GDP-compliance plan. Make sure that any departure & intermediate hubs are integrated as well! *GHA = General Handling Agents

22 Partner selection and qualification Areas for pre-go live qualification Quality Agreement Documentation of processes and workflows Change control Deviation handling Training

23 Partner selection and qualification Documentation of processes and workflows Topics that should be covered include: Contact details Hours of operation Public & company holidays Products and special requirements Packaging components Documentation Labelling Pickup Re-icing Special requirements at origin & destination Pre-alerts Irregularities Tracking & tracing

24 Partner selection and qualification Training Develop training modules for the specific needs Make sure that both parties talk the same language Include all staff levels for the trainings Keep the ball rolling every change could result in lack of knowledge

25 Partner selection and qualification Ongoing performance management: deviations

26 Partner selection and qualification Monthly performance monitoring (examples) Measurement per reason code /carrier Measurement of response time

27 Presentation Outline Pharmaceutical Quality Management Partner Selection and Qualification Shipping Qualification

28 Shipping qualification The concept Qualification is a documented testing that demonstrates with a high degree of assurance that a specific process will meet its predetermined acceptance criteria. The objective of a shipping qualification process is to verify that product can be shipped throughout the supply chain within required temperature and humidity ranges and without damage. Shipping qualification utilizes a lifecycle methodology integrated with quality risk management. Material / material group 1. QPP (Qualification Project Plan) 2. URS (user, material, thermal, mechanical requiremen 3. Risk Assesment 4. DQ / OQ / PQ 5. Summary Report Shipping method +

29 Shipping qualification Qualification needs Packaging and shipping method qualified for material (including any temperature or humidity requirements) different quantities lanes (origin-destination) transport duration Logistics service provider must be qualified prior to their use selection quality agreement implementation ongoing monitoring SQAS certification for dangerous goods SQAS (Safety & Quality Assessment System)

30 Shipping qualification Qualification lifecycle QPP Key planning document to define the scope of the project, outline the qualification rationale and list all qualification activities. URS Defines the high-level requirements the shipping system must meet (thermal & mechanical material requirements, acceptance criteria, lane requirements and load size and configuration). RA Must address risks related to user requirements and include identification of risk control actions and identify apropiate qualification tests. DQ / OQ / PQ DQ: ensures the user requirements are captured in the design deliverables OQ: comprises a set of tests that are conducted under controlled conditions PQ: consists of actual shipments through representative distribution networks QSR The Qualification Summary Report is the documentary evidence that all qualification activities identified in the QPP have been completed and all acceptance criteria were met

31 Shipping qualification Be careful with vendor qualified systems Thermal acceptability: Check if qualification from the supplier covers all your requirements. Mechanical acceptability: Check if a mechanical testing was performed and if additional testing is required. Qualification robustness: Assess if the qualification documentation from the supplier is sufficient or if further qualification activities are required.

32 Choosing the right supplier Moving towards GxP compliance Quality Systems: Processes and SOPs People: Education/Training/ Experience Technology: Packaging and Monitoring

33 Thank you for your attention. Michael Fleischer Regional Quality Coordinator NCEE GMP Compliance & QA Manager 32