Retrospective Validation.

by Jason Carp
(Texas. )

Is Retrospective Validation a recognised Procedure?

Nearly all countries have a regulatory authority which oversees the production of medical products, those that do not, usually recognise other authorities such as the FDA. In this regulated field there is never a good enough excuse for manufacturing regulated product (including batches for human trials), using none validated equipment, utilities, facilities and or processes.

Prior to an Installation Qualification (IQ) being executed for a piece of equipment, it is required to be comprehensively tested in the vendor’s establishment, by the execution of a Factory Acceptance Test (FAT), this is followed, once on site, by the execution of a Site Acceptance Test (SAT) which is integrated with the site commissioning. You must not be making adjustments or alterations to settings during IQ or OQ, these should all have been completed in the SAT/commissioning phase.

The build history of equipment and software is essential, because during IQ execution, you may have to review it, and assess the equipment / software quality, from it.

Retrospective validation has to be justified, and this justification is usually given in a Validation Plan (VP), which then becomes your authority to validate. In this VP you document your justification, along with the subsequent action you intend to take. You detail the scope and the responsibilities for all the proposed validation activities. You then get the company senior managers to approve it.

Some acceptable reasons for retrospective validation;
Your product was directed at home market, now you want to expand to a FDA controlled market.
Product line was stopped, now you want to restart.
Your company practices and procedures state that all validation will be reviewed at (1,2,3,) yearly intervals.
Legislation has changed.
The original validation was found to be inadequate.
Recommendation from a reviewing consultant has led to your decision to revalidate.

Whatever the reason get it documented in a VP.

Remember validation is completed using a series of documents each one as important as the next one. Get the sequence in place and validation becomes orderly, simple, robust and most importantly compliant.

Click here to post comments

Return to UNIQUE PROBLEM.


Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.