What Is ISO-13485/ MDD 93/42/EEC, FDA cgmp Systems Validation Protocol?

Transcription

1 ATL Pharmaceutical/ Medical What Is ISO-13485/ MDD 93/42/EEC, FDA cgmp Systems Validation Protocol? Leaders in Pharmaceutical and Medical Converting

2 SYSTEMS VALIDATION PROTOCOL INCLUDES ALL OF THE ELEMENTS LISTED ON THIS PAGE AND MORE, INCLUDING SIX-SIGMA. SIGMA.

3 ATL Specializes in Converting, (die-cutting, laminating, stripping, sheeting, etc.) Manufacturing of Pressure Sensitive Labels, and Disposable Medical Devices. Validation Is An Important Part Of Our Manufacturing Cycle.

4 Validation Allocation of Resources Time Very precious resource. Timing is everything. Wasted Effort Drastically reduced. ATL s idea is to get your product to market as quickly as possible.

5 Validation Allocation of Resources People All ATL personnel are specialists working for you. Ideas ATL s engineering skills and knowledgeable staff complement your needs through concurrent development.

6 Validation Allocation of Resources ATL s Facility Newly constructed world class manufacturing center in Menomonee Falls, Wisconsin. We can bring your product to market. An entire assembly or a beautiful label

7 ATL Plant, W140 N9504 Fountain Blvd, Menomonee Falls, Wisconsin, Phone

8 FDA cgmp/ ISO-13485/ MDD 93/42/ EEC Validation Begins With Customer Planning Formulate Product Development by Identifying Customer Needs Customer Requirements (Intended Use of Product) Six-Sigma Approach Used (DMAIC) Define, Measure, Analyze, Improve, Control APQP (Advanced Product Quality Planning)

9 FDA cgmp/ ISO-13485/ MDD 93/42/ EEC Validation Begins With Customer Planning Implement Process Development from Customer s Design Goals Establish Necessary Materials Process Flow, ISO Risk Analysis Timeline for Completion ATL Roles and Responsibilities Feasibilities of Your Proposed Product as ranked by product RISK

10 FDA cgmp/ ISO-13485/ MDD 93/42/ EEC Validation Begins With Customer Planning Evaluate and Control Manufacturing Process Packaging Standards Your Characteristics critical, major, and minor Perform FMEA (Failure Modes & Effects Analysis)

11 FDA cgmp/ ISO-13485/ MDD 93/42/ EEC Validation Begins With Customer Planning Develop Your Product Control Plan or FDA cgmp Performance Qualification (PQ) This includes: Product Process Operations Machines Characteristics Class Specification Tolerances Measurement Technique Cpk Determination Sample Size Sample Frequency Control Method Reaction Plan

12 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Phase A.P.Q.P. Advanced Product Quality Planning Phase 1 Customer Requirements Design Process For Manufacturability Concurrent process development Understand Intended Use For Product

13 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Phase A.P.Q.P. Advanced Product Quality Planning Phase 2 - Process Methods Process Characteristics Materials Packaging Standards

14 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Phase A.P.Q.P. Advanced Product Quality Planning Phase 3 - Finalization of Test Run and Process Mapping Preliminary control plan Part approval process MSA (Measurement System Analysis)

15 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Phase A.P.Q.P. Advanced Product Quality Planning Phase 4 Test (Preliminary) Production Run Determination of conformance capability Production control plan Production Validation Feedback To Customer

16 Plan Act Our Quality System Always Has Its Focus On The Customer Do Study

17 We Implement ATL s FDA cgmp/ ISO Validation To Think Like Our Customer 1. Identify what the customer s needs are: 2. Describe what Characteristics are critical, major, or minor for product conformance. 3. APQP: Formulate a process 8.Create control plan 7. Analyze Sequence of Cause-Effect Events 6. Determine Materials 5. Synchronize Information 4. Establish Time Line 9. Run Process 10. Verify & Validate 11. Satisfy Customer

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19 ATL s products & services almost unlimited

20 FDA cgmp/ ISO-13485/ MDD/93/42/EEC Validation 4 Steps to Establish Control 1. Set a Standard, Goal or Target: Fully Understand The Voice of the Customer (Your Specific Needs). Identify Equipment Needed. Develop Prototype Control Plan. Establish Gages & Testing Equipment.

21 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Steps to Establish Control 2. Process Design & Development: Process Concept. Inter-Relationships Characteristics to Machine Variability. Dimensional Tolerances. Performance Requirements. Material Handling. Process FMEA. Control Plan (start).

22 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Steps to Establish Control 3. After Process Development, ATL Will Finalize Your Test Run Requirements: Packaging Standards. Quality System Review. Control Plan (Finished). Process Instructions Completed. Device History Completed. Special Processes Developed.

23 FDA cgmp/ ISO-13485/ MDD 93/42/EEC Validation 4 Steps to Establish Control 4. Verify & Validate This Includes: Production Test Run. FDA cgmp P.Q. or Control Plan Implementation. PPAP and/or Final Inspection Performed. Production Validation. Capability and/or Conformance Evaluation. Packaging Evaluation. Control Plan Formalized. Manufacturing & Quality Feedback. Test Run Sign-off. Report to (end user) Customer.

24 ATL takes pride in cgmp compliance (21 CFR 210, 211, 820) for pharmaceutical labels & medical devices. Since 1999 our pharmaceutical validation record has been better than % conformance with zero product recalls. (Based on a systems protocol sample size of more than 3,000,000 units over 16 years.)

25 Registered Medical Device Manufacturer # Audited for FDA cgmp, ISO-13485, MDD 93/42/EEC compliance. ATL s Liability & Responsibility is Different than Other Printers. Process Validation. Statistical Process Control.

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27 FDA cgmp Pharmaceutical Label Quality Assurance

28 ATL s FDA cgmp/ ISO MDD/93/42/EEC Validation Staff Is Ready To Serve You Full time engineers and project managers. Tooling specialists. Sales engineers knowledgeable about ATL processes. Quality staff to manufacturing ratio is 1:8. ATL s manufacturing facility is FDA cgmp compliant. Very low employee turnover- this provides a consistency for repeat orders. Our facility (and staff) have passed pharmaceutical/ medical audits preformed by Bristol-Myers Squibb, Novartis, Eli Lilly, Abbott Labs, Pfizer, G.E. Medical, and many others.

29 ATL s Mission Statement The goal of FDA cgmp/ ISO-13485/ MDD/93/42/EEC Validation is to: Execute one project, yours successfully, making the best product, delivered on time. We are dedicated to following 3 principles: Listening to the voice of the customer. APQP (Advanced Product Quality Planning). Superior Manufacturing Quality Through Six Sigma (DMAIC)

30 Structure and Design of FDA cgmp/ ISO MDD/93/42/EEC Validation is Organization ATL s Staff is a flat structure where everyone works together on the same level for you.

31 Structure and Design of FDA cgmp/ ISO MDD/93/42/EEC Validation is Organization ATL s Process Design is functional and efficient, each person has a specific responsibility, all working in concert, focused on you.

32 Structure and Design of FDA cgmp/ ISO Validation is Organization ATL s Engineering Project Manager, focused on your project, implements FDA cgmp/ ISO-13485/ MDD/93/42/EEC Validation all in concurrent development, and in a smooth and fluid timeline.

33 ATL s Project Coordinator transforms critical information from the VOC into ATL s technical language. Voice of the Customer Intended Use Of Product Tooling Templates/ Drawings Materials Project Requirements Production Details Regulatory Requirements

34 Voice of the Customer ( VOC ) The VOC fully details end user customer labeling requirements: Customer Information Construction Dimensions Materials Total Quantity Special Requirements The critical to quality (CTQ s) characteristics to be established in concert with the customer approved specifications

35 Project Requirements The VOC is translated into technical language that is understood by ATL personnel. Tooling Template Material Production Details Art / Plate Once project requirements are detailed, ATL art and job requirements can be set into motion (Job Ticket Established).

36 Tooling Rotary tooling is an ATL engineering specialty. The engineer that orders your tooling is a specialist in template layout design, and, matches the rotary tool specifically for the job. Backup tooling is kept on hand for jobs with higher quantities.

37 Material The project engineer translates the required materials into specifications for ATL purchasing: Face Stock Adhesives Base Stock Width The purchasing department orders the materials and kits each specific job number s (required stocks) in advance of production.

38 Job Ticket Order Entry Scheduling Customer Order Material Purchase Order Art Work Purchase Order Job Ticket Floor Plates Purchase Order Customer Acknowledgement

39 Three Types of (Device) Master Records Medical Master Record Prototype Master Record Production Master Record ATL manufactures a wide variety of products for their customers. The product history includes the description of the methods used in production for a specific construction.

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41 On-Press Inspection Pharmaceutical/ Medical Quality Check Startup Pharmaceutical Medical Product Quality Dept. Traveler In-Process Label Attachments Or Samples Item Traceability

42 The device history for pharmaceutical orders is stored securely in a locked area. Medical Master Record

43 Pharmaceutical Medical Product Quality Dept. Traveler There are four sign-offs required on the Traveler. Line Clearance. First Article S/U documentation. Final Quality (Inspection) documentation. Final documentation (batch record) complete. As the name implies, the Quality Traveler travels with the job.

44 Change Control The ATL Change Control form coordinates significant changes to an item or process. This includes Manufacturing Instructions Equipment Qualifications Notification to Customer Tooling Training SOP s Raw Materials Specifications Process Controls Art Department Existing P.Q. s (FDA cgmp Performance Qualifications) The initiation and closeout of all change controls must be approved by the Quality Manager.

45 ATL Performance Qualification An ATL PQ is done on a regular basis to each press to access total output (in conformance percentage). A PQ is also performed for color variation (in blinded studies) for Cpk determination (defects per million), after major maintenance, and, as an ongoing assessment tool in Systems Validation Protocol. ( I.Q., O.Q., P.Q. )

46 Equipment Qualification Review The ATL Quality Management System (QMS) describes what we do. The Standard Operating Procedures (SOP) Manual describes how we do it. The Systems Validation Protocol (SVP) is a validation master plan, and describes to what extent we do what we do. This is expressed as defects per million (Cpk), conformance percentage, or a validation in yes or no terms (such as a computer test). The Equipment Qualification Review is used to validate process functions, as they relate to various pieces of ATL equipment. For further clarification, see the next slide, Performance Qualification Review.

47 Performance Qualification Review Both the Performance Qualification and the Equipment Qualification reviews are used with the Systems Validation Protocol. Common items to the PQ and EQ are: Process Specific Identification Product Features To Qualify Qualification (List of Characteristics to Validate) Qualification Results Qualification Acceptance The difference between the two: An EQ is for equipment only. A PQ may be for equipment, vendor, process, or procedure.

48 This is an Actual EQ for color variation, expressed in L* a* b* readings. The Cpk for L The Cpk for a The Cpk for b Bell Curves Are Shown On Next Page

49 L L a a b b The process is in control, and capable. This Equipment Qualification is acceptable.

50 Final Documentation Checklist The ATL Batch Record is completed for each order. A typical batch record includes: Quality check start up inspection Copy of material roll tags All pharmaceutical label in-process inspection sheets In-process samples (kept in production sequence) Copy of current Quality Traveler Current Master record Copy of Final Inspection sheet Green Released label

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52 Thank You! Ad Tape & Label

53 Ad Tape & Label Author: Donald J. Dobert, President, ATL W140 N9504 Fountain Blvd Menomonee Falls, WI Phone (262) Toll Free Fax (262)