validación de procesos ron weber fda

Ron Weber SUDs Workshop 5/11/01

Process Validation

By Ron WeberDevice SpecialistFlorida District Office


Purpose & Scope

DefinitionHistoryImportance for SUDs

ReprocessorsOverview


Process Validation

GHTF - Documented procedure and process for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.

1987 Guidance - Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.

Definition


Process Validation

Quality System Definition:ESTABLISHING by objective evidence

that a process consistently produces a result or product meeting its

predetermined specifications.

•Define•Document•Implement

•Define•Document•Implement


Monitoring & Control

Establish and maintain procedures to ensure that the specified requirements continue to be met. [21 CFR

820.75(b)(1)] Management of applied process parameters

[APP]

Six Sigma


APP/Rejects

Loose controls= high rejects

Le s s

APP

REJECT RATE


Common Denominator

ZERODEFECTS


History

Birth in Aerospace Industry

Increase in Recalls during 1980s

1987 Guidance Document - (http://www.fda.gov/cdrh/ode/ 425.pdf)


Good Guidance Practices

This guidance was written prior to the February27,1997 implementation of FDA’s Good GuidancePractices, GGPs. It does not create or confer rightsfor any or on any person and does not operate to bindFDA or the public. An alternative approach may beused if such approach satisfies the requirements ofthe applicable statute, regulation, or both. Thisguidance will be updated in the next revision toinclude the standard elements of GGPs.


Importance

Increased control of process

Increase production of higher quality devices - Ex: IOLs

Confirm Process Design


Processes to Validate

Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.


Validation - Verification

Verification - Confirmation byexamination and provision of objectiveevidence that specified requirementshave been fulfilled.

Validation - Confirmation by examination and provision of object evidence that the particular requirements for a specific intended use can be consistently fulfilled.


Is Process Output Verifiable?

YesVerify & Control the Process?

Yes

What is level of RISK TO PATIENT?

No No

Validate to Control RISK

Redesign Product and /or Process

HIGH OPTIONS

Accept Risk of Limited Process Control

Validate for Business Reasons

Process Validation Decision Tree

LOW OPTIONS

Is verification Sufficient & Cost Effective?


Processes that should be Validated

Sterilization Process & Test Software Clean Room Ambient Conditions Aseptic filling processes Sterile packaging sealing processes Lyophilization process


Processes which may be satisfactorily verified

Manual cutting process

Testing for color, turbidity, pH

Visual inspection of PCBs

Manufacturing and testing of wiring harnesses


Use Decision Tree

Cleaning processes

Certain Human assembly processes

Filling process


Process Validation

1. Planning

2. Installation Qualification

3. Operational Qualification

4. Process/Product Qualification

5. Process Monitoring

6. Revalidate


Protocol

A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.


Installation Qualification(IQ)

Ensure that all equipment used inmanufacturing, including ancillarysystems, meets specifiedrequirements and is appropriatelydesigned, constructed, placed andinstalled to facilitate maintenance, adjustment, cleaning, and use.[21 CFR 820.70(g)]


Operational Qualification (OQ)

Establishing parameters by objective evidence which result in product that meets all predetermined requirements.

Shows that the equipment operates properly and determines optimal process settings.


OQ

Determine if process is capable

Does it operate within specified parameters?

Does it produce a product or result that meets specifications?


OQ

Develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. [21 CFR820.70(a)]

Establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specification. [21 CFR820.70(a)]


Performance Qualification (PQ)

Establish by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.


PQ

Performance qualification involves repetitive testing (multiple batches) to show that the process will consistently result in a product meeting specifications (including product testing under simulated use conditions, if applicable).


PQ

The confidence in the process is augmented by increasing the number of batches run and the number of samples tested.

•The reliability and consistency of the process can be shown by performing statistical calculations.


Non-conformities

Non-conformities often occur because of errors made and because of excessive variation.

Many non-conformities are not the result of errors but the result of EXCESSIVE VARIATION AND OFF-TARGET PROCESSES


Unstable Process

It must be FDA’s fault!


Stable Process

I tamed the process. How about a raise?


Strategies & Tools for reducing variation and Optimizing the

process Average

Mistake Proofing Capability Study Challenge Tests Acceptance

Sampling Plans Component

Swapping Study Control Charts

Analysis of Means Analysis of Variation Failure Mode and

Effects Analysis Fault Tree Analysis Robust Design

Methods


Capability Study

Measures the ability of the process to consistently meet the specification.

Frequently used towards the end of validation to demonstrate that the products consistently meet the specifications


Capability Study

Performed by selecting a small number of units periodically over time

Averages and ranges are plotted over time using a control chart to determine if the process is stable.


A capability study is used to determine whether a process

is stable and capable.


Documentation

Master Validation Protocol or Plan

Protocols or Plans for:• Installation Qualification• Operational Qualification• Performance/Product Qualification


Documentation

Data Collection and Analyses

Final Report - deviations, conclusions and approval

Don’t forget: Acceptance Criteria for successful study

I didn’t know we needed them.


Software

When computers or automated data processing systems are used as a part of the production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. [21 CFR820.70(I)]


Software

The output of the process may be fully verifiable and the overall process may not require validation however software used for automation or testing such processes should always be validated for its intended use.

validación de procesos ron weber fda

Documents

pdfron weber suds workshop

specific process

process output verifiable

validation confirmation

predetermined specifications

riskredesign product

product complying

documented evidence