Information & Training. | Product and Process Validation.

Component Qualification…

… Facility Qualification. Material Qualification. Fixture Qualification….

“A protocol designed to demonstrate that a component / material meets its specifications.”

In order to effectively qualify an item of equipment, the components used need to be confirmed as suitable for use. Depending on the criticality of the item of equipment within a process, the components can be qualified in situ or preliminary qualification testing may be necessary.

In all situations there will be pre-defined and pre-approved test plans for critical components with pre-defined acceptance criteria.

Where applicable, a component qualification includes:

Product functional tests

Biocompatibility tests

Packaging qualification tests

Shipping/ handling requirements and tests

Addition of supplier to “qualified supplier list”

These tests may be performed under the same protocol or under several separate protocols.

Component or material qualifications may be used to qualify a supplier by qualifying the parts supplied.

As with all qualifications and validations, a risk assessment will drive the level of testing to be performed. The residual risk levels remaining after a component qualification will determine the requirements for repeat validations or the implementation of ongoing verification activities.

The Validation Master Plan (VMP)
Validation during the Design processes
Software Validation
Cleaning Validation
Cleaning Process Sampling and Test Methods
Documentation Management for Validation compliance
Equipment, Component, Material and Facility Validation
Implementation of a re-Validation process
Protocol Reporting
Implementation of the Audit process to assure Validation effectiveness
How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
Information & Training presentation >>>

Facility Qualification

Facility qualification is focused on confirming that a facility is “fit for purpose”. This may apply to the manufacture of products, may be a storage facility, may be a sterilization facility, etc.. A facility qualification in common with all such qualifications will require documented test and qualification protocols, pre-defined acceptance criteria and signed off reports. Normal practice will be that the facility qualification will be one component of an overall master validation plan.

The first step in a facility qualification will be to perform a risk analysis. Where can risks arise to the product, the process, the employees, the community, to regulatory compliance, etc.. that may result from deficiencies in the facility. The risk analysis will drive the areas and level of focus within the facility test protocols.

A facility qualification may focus on the suitability of utilities, for example:

i) what type of water may be required.. “WFI – water for injection”?

ii) what electrical power will be needed, where must electrical power be provided within the facility?

iii) must heating, moisture levels be controlled? Etc..

Will there be clean-rooms or controlled environments within the facility? What particulate levels will be required? Will there be requirements for air extraction via flow hoods from specific rooms?

Will potentially explosive gasses or chemicals be in use? If yes, what type of air circulation and extraction will be required? Will there be a requirement for specific electrical switching within these environments?

Will there be chemicals discharged to drains which come under license requirements? How will such discharged be managed and monitored?

Will there be specific lighting requirements?

Etc., etc..

The facility requirements will need to be defined in advance of any use, defined test methods agreed and performed to ensure all necessary expectations can be consistently delivered.

Fixture Qualification

“A protocol designed to establish confidence that a fixture conforms to its specifications (approved drawings), operates as it is intended to function, and the results obtained with the fixture are reproducible and repeatable.”

A fixture is a piece of equipment containing one or several parts, assembled together in a particular arrangement to perform processes such as Welding, Machining, etc., in order to hold, provide, or force a fixed relationship between the different parts. A fixture does not change or alter the parts (i.e., a “Cannula Bending” or a “Blow-Off System” is not a fixture but a process or item of equipment).

Documentation and tests normally performed during a fixture qualification:

Drawings/ schematics review (IQ)

First article on major dimensions (IQ)

Operational tests (OQ)

Documentation verification (OQ)

Training verification (OQ)

Performance tests (PQ)

If applicable:

Calibration is applicable when items which can be calibrated (e.g., Micrometers, air pressure gauge) are part of the fixture and are used in a predefined range which is specified in a process document or a manufacturing procedure.

Information & Training.

Product and Process Validation.

Validation versus Verification
Integration of Risk into Validation
Validation Gap Analysis
Implementing a Validation Process (IQ, OQ, PQ)
The Validation Master Plan (VMP)
Validation during the Design processes
Software Validation
Cleaning Validation
Cleaning Process Sampling and Test Methods
Documentation Management for Validation compliance
Equipment, Component, Material and Facility Validation
Implementation of a re-Validation process
Protocol Reporting
Implementation of the Audit process to assure Validation effectiveness
How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
Information & Training presentation >>>