Promoting Quality OINDP Components- A Supplier Perspective

Transcription

1 Promoting Quality OINDP Components- A Supplier Perspective Tom Gaspar Vice President Quality Assurance, Manufacturing and Development Support West Pharmaceutical Services IPAC-RS Conference November Overview The Desired State for Suppliers Role of IPAC-RS Guideline Product Realization Key Components of a Quality System How do I Get from Here to There? 2 1

2 The Desired State for Suppliers Quality is Moving to the Next Level Now Specification (AQL) Now/Future Specification (6σ; 3.4dpm;0 defects;cpk) 3 The Desired State for Suppliers Final QC Sampling (statistical sampling ANSI/ASQ Z1.4) Product Assessment Quality by Design (In-process controls, PAT, Continuous Monitoring, Verification) 4 2

3 The Desired State for Suppliers To move from Today to Tomorrow suppliers to the OINDP industry must: Understand the Customer Requirements Design the product and process to produce and deliver the product as required Establish controls to ensure continuous production to requirements Establish feedback loops (internal/external) to continuously improve the process/product 5 Quality Management System A Quality Management System Provides the Infrastructure to Accomplish Product Realization, Product Conformance, and Product Improvement 6 3

4 Role of IPAC-RS GMP Guideline IPAC-RS GMP Guideline for Suppliers of Components for OINDP is a blueprint to follow in building a Quality Management System From ISO 9000:2001 Section 0.2 Figure 1 7 Role of IPAC-RS GMP Guideline IPAC-RS Guideline is complementary to ISO 9001:2000 and PS 9000:2001 Also is in alignment with 21 CFR and 820 The IPAC-RS Guideline fits in with the current thinking on Quality by Design and Quality Management Systems and is in line with the direction of the industry 8 4

5 Product Realization: Quality by Design Design Requirements Inputs Outputs Validation Verification Changes Process Control Purchasing Control 9 Tools for Continuous Improvement Measurement, Analysis and Improvements Statistical Techniques Receiving Inspection In-process Inspection/Monitoring Final Inspection Audits Corrective/Preventive Actions Customer Feedback Workforce Feedback 10 5

6 Product Realization: QbD Management Responsibilities Quality Organization Quality Policy Responsibilities Document and Data Control 11 Product Realization: QbD Resource Management Available Resources at all Levels Training Resource Feedback 12 6

7 Product Realization: QbD In Building Quality for the Customer the Supplier Must LISTEN 13 Who is Involved in the Conversation? Customer Customer Design Engineer Customer Operations Customer QA Supplier Supplier Design Engineer Supplier Operations Supplier QA Supplier Purchasing 14 7

8 Product Realization: QbD Inputs Define Requirements at all Levels (Present/Future) Equipment Controls Documentation Resources Etc. 15 Product Realization: QbD Requirements will be Used in Designing the Product, the Manufacturing Process and Controls Outputs Final Product Requirements agreed to Product can be Measured against Requirements Areas of Future Improvement Defined 16 8

9 Product Realization: QbD Validate to Requirements Process Controls 17 Key Components of a Quality System Change Control Process Improvements/Equipment Improvements Need to be Captured Under Change Control Corrective and Preventive Actions Need to be Captured Under Change Control Ensures Process Remains in a Validated State Ensure Requirements Continue to be Met or Exceeded 18 9

10 Key Components of a Quality System Process Control Operation Set-up and Verification Manual and Documented Computerized Validated Manufacturing Execution System In-Process Inspection/Monitoring Statistical Process Control Process Audits In-line PAT 19 Key Components of a Quality System Process Control (Cont d) Final QC Batch Record Review Manual Documentation Review Electronic Batch Record Review 20 10

11 Key Components of a Quality System Continuous Improvement LISTEN to the PROCESS (Develop systems to capture information/data for analysis) Scrap Rate Downtime Final Product Rejection Rework Reprocess Throughput 21 Key Components of a Quality System Continuous Improvement LISTEN to the CUSTOMER (Develop system to capture information/data for analysis) Audits Complaints Inquiries Rejections Customer surveys Market trends 22 11

12 Key Components of a Quality System Continuous Improvement Analyze the Information/Data Prioritize Define Corrective/Preventive Actions Institute Change Control Validate/Qualify Measure Effectiveness Update Quality System Redefine Requirements 23 Getting There: the IPAC-RS GMP Guideline The GMP Guideline for Suppliers of Components for OINDP provides the blueprint Follows from and in line with ISO 9001:2000, 21 CFR and 820, and PS 9000 Your organization must decide the implementation plan By following the blueprint you will build a Quality Management System that will house a Quality by Design program 24 12