009 what are the systems validation protocol methods at atl 05 28-2015

Leaders in Pharmaceuticaland Medical Converting

ATL Pharmaceutical/ Medical

What Is ISO-13485/

MDD 93/42/EEC, FDA cGMP

Systems Validation Protocol ?

SYSTEMS VALIDATION PROTOCOL SYSTEMS VALIDATION PROTOCOL SYSTEMS VALIDATION PROTOCOL SYSTEMS VALIDATION PROTOCOL

INCLUDES ALL OF THE ELEMENTS INCLUDES ALL OF THE ELEMENTS INCLUDES ALL OF THE ELEMENTS INCLUDES ALL OF THE ELEMENTS

LISTED ON THIS PAGE……LISTED ON THIS PAGE……LISTED ON THIS PAGE……LISTED ON THIS PAGE……

AND MORE, INCLUDING SIXAND MORE, INCLUDING SIXAND MORE, INCLUDING SIXAND MORE, INCLUDING SIX----SIGMA.SIGMA.SIGMA.SIGMA.

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.

Time

Very precious resource. Timing is everything.

Validation

Allocation of Resources

Wasted Effort

Drastically reduced. ATL’s idea is to get yourproduct to market as quickly as possible.

PeopleAll ATL personnel are specialists

working for you.

IdeasATL’s engineering skills and knowledgeable

staff complement your needs through

concurrent development.

Validation


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 …

Validation


ATL Plant, W140 N9504 Fountain Blvd, Menomonee Falls, Wisconsin, 53051ATL Plant, W140 N9504 Fountain Blvd, Menomonee Falls, Wisconsin, 53051ATL Plant, W140 N9504 Fountain Blvd, Menomonee Falls, Wisconsin, 53051ATL Plant, W140 N9504 Fountain Blvd, Menomonee Falls, Wisconsin, 53051

Phone 262Phone 262Phone 262Phone 262----255255255255----6150 8006150 8006150 8006150 800----444444444444----5144 www.atlco.com5144 www.atlco.com5144 www.atlco.com5144 www.atlco.com

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)

Implement Process Development from

Customer’s Design Goals…

•Establish Necessary Materials

• Process Flow, ISO-14971 Risk Analysis

• Timeline for Completion

• ATL Roles and Responsibilities

•Feasibilities of Your Proposed Product as ranked by product RISK




Evaluate and Control Manufacturing Process

•Packaging Standards

•Your Characteristics – critical, major, and minor

•Perform FMEA (Failure Modes & Effects Analysis)




Develop Your Product Control Plan or

FDA cGMP Performance Qualification (PQ)

•Measurement Technique

•Cpk Determination

•Sample Size

•Sample Frequency

•Control Method

•Reaction Plan

This includes:

•Product

•Process

•Operations

•Machines

•Characteristics Class

•Specification Tolerances





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

Phase 2 - Process Methods

• Process Characteristics

• Materials

• Packaging Standards



4 Phase A.P.Q.P.


Phase 3 - Finalization of Test Run and Process Mapping

• Preliminary control plan

• Part approval process

• MSA (Measurement System Analysis)



4 Phase A.P.Q.P.


Phase 4 – Test (Preliminary) Production Run

• Determination of conformance capability

• Production control plan

• Production Validation

• Feedback To Customer



4 Phase A.P.Q.P.


Our Quality System

Always Has Its

Focus On The

Customer

Do

Plan

Act

Study

We Implement ATL’s FDA cGMP/ ISO-13485 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

10. Verify &

Validate

9. Run

Process

5.

Synchronize

Information

4.

Establish

Time Line

6.

Determine

Materials

11. Satisfy Customer

ATL’s products & services …almost unlimited


MDD/93/42/EEC Validation4 Steps to Establish Control

• Fully Understand “The Voice of the

Customer” (Your Specific Needs).

• Identify Equipment Needed.

• Develop Prototype Control Plan.

• Establish Gages & Testing Equipment.

1. Set a Standard, Goal or Target:

2. Process Design & Development:

• Process Concept.

• Inter-Relationships –

Characteristics to Machine

Variability.

• Dimensional Tolerances.

•Performance Requirements.

•Material Handling.

•Process FMEA.

•Control Plan (start).



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.




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.




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

99.985% conformance

with zero product recalls.

(Based on a systems

protocol sample size of

more than 3,000,000

units over 16 years.)

Registered Medical Device Manufacturer # 2183564

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.

FDA cGMP

Pharmaceutical Label

Quality Assurance

ATL’s FDA cGMP/ ISO-13485

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.

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)

Structure and Design of

FDA cGMP/ ISO-13485


is Organization

ATL’s Staff is a flat structure where everyone works together

on the same level for you.


FDA cGMP/ ISO-13485


is Organization

ATL’s Process Design is functional and efficient, each person has a specific

responsibility, all working in concert,focused on you.

ATL’s Engineering Project Manager,

focused on your project,

implements FDA cGMP/ ISO-13485/


all in concurrent development,

and in a smooth and fluid timeline.


FDA cGMP/ ISO-13485

Validation

is Organization

ATL’s Project Coordinator

transforms critical information from the

“VOC” into ATL’s technical language.

Intended Use Of

Product Materials

Templates/

Drawings

Regulatory

Requirements

Project

Requirements

Voice

of the

Customer

Production Details

Tooling

� Materials

� Total Quantity

� Special Requirements

� Customer Information

� Construction

� Dimensions

Voice of the Customer

( VOC )

The VOC fully details “end user” customer labeling requirements:

The critical to quality (CTQ’s) characteristics to be established in concert with the “customer approved specifications”

Project Requirements

� Tooling

� Template

� Material

� Production Details

� Art / Plate

The VOC is translated into

technical language that is

understood by ATL personnel.

Once project requirements are

detailed, ATL “art” and “job”

requirements can be set into

motion (Job Ticket Established).

Tooling

� 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.

Rotary tooling is an ATL engineering specialty.

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.

Customer Order

Customer

Acknowledgement

Material

Purchase Order

Plates

Purchase OrderJob Ticket

“Floor”

“Scheduling”

Art Work Purchase

Order

Job Ticket Order Entry

Medical Master Record

Prototype Master Record

Production Master Record

Three Types of (Device) Master Records

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.

On-Press Inspection

Pharmaceutical/ Medical

Quality Check Startup

Pharmaceutical – Medical Product

Quality Dept. Traveler

In-Process

Label Attachments

Or Samples

Item Traceability

The device history for

pharmaceutical orders

is stored securely in a

locked area.

Medical Master Record

As the name implies, the Quality Traveler

“travels” with the job.

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.

Pharmaceutical – Medical Product

Quality Dept. Traveler

Change Control

The ATL “Change Control” form coordinates significant changes

to an item or process. This includes…

The initiation and closeout of all change controls must be

approved by the Quality Manager.

� Existing P.Q.’s (FDA cGMP Performance Qualifications)

� Art Department

� Process Controls

� Specifications

� Raw Materials

� SOP’s

� Training

� Tooling

� Notification to Customer

� Equipment Qualifications

� Manufacturing Instructions

ATL Performance Qualification

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

An ATL PQ is done on a

regular basis to each

press to access total

output (in conformance

percentage).

“Systems Validation Protocol”.

( I.Q., O.Q., P.Q. )

Equipment Qualification Review

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”.

The ATL “Quality Management System” (QMS) describes “what” we do.

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 “Standard Operating Procedures” (SOP) Manual describes “how” we do it.

Performance Qualification Review

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.

Both the “Performance Qualification” and the “Equipment Qualification”

reviews are used with the “Systems Validation Protocol”.

Common items to the “PQ” and “EQ” are:

Bell Curves

Are Shown

On Next Page

The Cpk for “L”

The Cpk for “a”

The Cpk for “b”

This is an

Actual “EQ”

for color

variation,

expressed in

L* a* b*

readings.

The process is in control, and

capable. This Equipment

Qualification is acceptable.

“L”

“a”

“b”

“L”

“a”

“b”

The ATL “Batch Record” is completed for each order.

Final Documentation Checklist

• Green “Released” label

• Copy of “Final Inspection” sheet

• Current “Master” record

• Copy of current “Quality Traveler”

• In-process samples (kept in production sequence)

• All pharmaceutical label in-process inspection sheets

• Copy of material roll tags

• Quality check start up inspection

A typical batch record includes:

Thank You!

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W140 N9504 Fountain Blvd

Menomonee Falls, WI 53051

Phone (262) 255 6150

Toll Free 800 444 5144

Fax (262) 255 4301

www.atlco.com

Author: Donald J. Dobert, President, ATL

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