An Industry Perspective

Transcription

1 Controls An Industry Perspective Presented by: Jay Gerondale Amgen Inc.

2 Overview Why are We Here? What are Controls? Control Elements Product Development Steps Conclusion

3 Bridging Making a Combination Product Drug/Biologic Device Combination Product

4 Devices/Combination Products For pharmaceutical company based quality systems, FDA s proposed 21 CFR part 4 identifies six additional requirements where these companies will need to update an existing quality system with QSR (21 CFR 820) elements. Controls (820.30) Purchasing Controls (820.50) Corrective and Preventive Actions (CAPA) ( ) Management Responsibilities (820.20) Installation ( ) Servicing ( )

5 What are Controls? Procedures to control the design of the device in order to ensure that specified design requirements are met. Controls are initiated early in the development process and guide an interactive process between designer and patient. Formal procedures that t are required throughout h t development to ensure Inputs address patient needs and Outputs translate the design into engineering and manufacturing requirements and specifications. Control records demonstrate that the product was developed in accordance with the design plan and archived as a History File.

6 What are Controls Controls consist of: and Development Planning Input Output Review Verification Validation Transfer Changes History File (DHF)

7 FDA Waterfall Model

8 Typical Development Path Controls Drug Co. Contract t Firm Mfg Co. Specification Developer er/developer Contract Manufacturer July 2007

9 Purchasing Controls The Manufacturer of Record (the company that manufacturers the device for sale to the end user) has responsibility for QSR compliance, including Controls The Manufacturer of Record must control their suppliers to assure that compliance with the QSRs are maintained i Product design contractors must be controlled to assure g that their work is QSR / Control compliant

10 Device & Drug Product Development Stages Devices 2-5 years Concept Planning Planning Verification Validation Process Validation Launch Post-Market Surveillance Discovery Development Commercialization Basic Research Pre-Clinical Clinical Testing Marketing Drugs years

11 A Typical 5-Phase Process for Devices Concept Planning Planning & Development Verification & Validation Transfer & Process Validation Launch Post- Market Surveillance

12 Concept Planning Asking the right questions! Patient More freedom Higher compliance Greater satisfaction Wider selection of medication options: Greater convenience of drug delivery Company Maintain/grow market share Build quality into the design Shorter time to market Greater company value

13 Planning and Development Cycle Testing Cycle and Development Planning Formal Plan established Prototypes developed Systematic assessment of design deliverables Review Input User needs and wants User environment Intuitive Performance requirements Risk Management initiation BOM s, drawings & manufacturing instructions Output Requirements Translate customer requirements into technical requirements Regulatory, clinical, and technical requirements Country specific regulatory requirements Technical, measureable, acceptable criteria for the design Performance Spec Review

14 Verification and Validation Transfer Characterization ti Basic technical capabilities demonstrated through models & prototypes Component life cycle testing Human Factors Review Risk Analysis Ensures patient safety is at the forefront of design Inputs into the testing regime Production equivalent units Ensures the device conforms to user needs & intended uses Validation Verification testing Device capability Reliability testing Conformance to product spec. Device does not affect drug Drug does not affect device

15 Transfer Cycle Transfer Transferring the design into manufacturing processes & procedures improvements e or changes cause the device to go back to the Device Planning Cycle Planning Cycle Review Final review e of the design FDA filing Product is released for sale improvements or changes Change Control Post Market Surveillance Product Surveillance & Failure Analysis Feedback received from the users

16 Why Can t We Catch Up Later? activities are captured in real time The rationale for design trade-offs and decisions are fresh The context in which design decisions are made is understood Risk mitigation is based on upstream design risk assessments

17 Conclusion The primary objective of design controls is to ensure products are safe and effective for their intended use. This can be achieved by: Minimizing the device s variability Minimizing the device s maintenance requirements Minimizing the possibility of mistakes occurring while the device is in use They make good business sense!

18 Questions?