Friday, October 5, 2007

Equipment Qualification versus Process Validation

Confusion.

ISPE's Baseline Guide Commissioning and Qualification clearly states that Equipment Qualification is not the same animal as a Process Validation.

I understand that Process Validation covers and verifies the repeatability, accuracy, and precision of a process while Equipment Qualification focuses on an individual piece of equipment.

But....

Other than the scope of the protocols, they are the exact same template. Why not then throw Equipment, Utilities, etc under the umbrella of Process Validation?

This many seem as a trivial complaint but it does not seem so small when there are six or seven different templates floating around.

BD

10 comments:

Anonymous said...

The Performance Qualification (PQ) portion of Equipment Qualification should be considered a subset of Process Validation - particularly if the equipment is dedicated to a process.

billehall@comcast.net

Mungur said...

It is almost impossible, based on my Validation experience, to incorporate Equipment/Utilities Qualification under the umbrella of Process Validation.

You're correct in saying that Equipment Qualification focuses on an individual piece of equipment, but you're disregarding a few key considerations which highlights the need for separate and different Validation approaches to these two areas of Validation.

When qualifying a piece of equipment, and let's cut to thaw chase, say, a fully automated PLC controlled filling machine which fills containers ranging in size from 5mL to 2L, then the validation approach cannot just be focussed on the machine operation and capability to perform in accordance with the manufacturer’s specification, its design spec and/or within its operational parameters.

The full product range must be considered (product type, viscosity, heated/ambient fill, suspension products), including the suitability of the packaging components (bottles, jars, tubes) and also the ability to maintain a homogeneous bulk mix through constant mixing/stirring and if required, effective product circulation & re-circulation.

All of these considerations have to be targeted, in-line with your relevant regulatory authorities requirements & maybe even the ISPE’s guide, way before the validation protocol had been written or the scope of testing and qualification had been considered. A User Requirement Specification (URS) is definitely the first document which must be drafted, reviewed and approved by both the purchaser and supplier of the complex piece of equipment or utility, before anything else can commence. Following that, Factory Acceptance Testing of the machine must be performed against a FAT Protocol which covers a level of DQ/IQ/OQ to ensure that the item supplied complies with the URS and to check/test the equipment’s design, finish, ability, process flow, in-line component /processing stations requirements, automation, etc.

Thus, for complex filling machines / BMCS controlled HVAC Systems / WFI Systems, all of which require vastly different tests & considerations, to the Process Validation approach, simply incorporating the qualification under the PV umbrella and template is, in my opinion, unnecessary and virtually impossible.

Qualification of bulk mixing equipment, verification of weighing equipment accuracy, etc, may potentially be incorporated under the PV umbrella.

Only a small portion of the Equipment Qualification (e.g. for complex filling machines) can be performed under the Process Validation umbrella and format and that is the final Performance Qualification (PQ) of the machine which requires either a placebo product / actual commercial batch (manufactured under the same conditions, from starting material dispensing to completion of compounding) to test the machine’s capabilities under varying conditions (product viscosity, speed of fill, fill weight, filling at varying product temps, process flow). Acceptability of machine performance is measured against the finished product’s compliance to its Finished Products Specifications and testing limits. The machine is considered validated if you can prove reproducibility of the operation/process, consistency of testing results, accuracy of fill and overall repeatability of the PROCESS.

URS/FAT/DQ/IQ/OQ cannot be “thrown” under the umbrella of Process Validation. KEEP THEM SEPARATE.

Yours Sincerely
Sean Mungur

P.S. I know that this is an old post, but I felt compelled to give my input, even if in reality nobody may read it….it was for my personal benefit :)

Ben Denham said...

Thank you for your input. My experience in the field of validation is growing quickly. I agree with all your comments and now struggle with the relationship between validation activities and commissioning.

Thanks again

Derica said...

Good words.

Ben Denham said...

What a difference a year makes.

I am now wrapped up in cleaning and device validation with a sprinkle of regulatory submission.

sanjayadashd said...

All of these considerations have to be targeted, in-line with your relevant regulatory authorities requirements & maybe even the ISPE’s guide, way before the validation protocol had been written or the scope of testing and qualification had been considered......automateandvalidate

RajivPaul said...

I personally do not agree with the idea of validation trials. This is a contradiction of terms as you can only really validate a process that is in control and working (in theory).

www.automateandvalidate.com

Nahla said...

Thank you for your input. My experience in the field of validation is growing quickly. I agree with all the comments and today struggle along with the relationship somewhere between validation events and also commissioning.

swagatika mahalik said...

Equipment Qualification focuses on an individual piece of equipment, but you're disregarding a few key considerations which highlights the need for separate and different Validation approaches to these two areas of Validation.
openit

swagatika mahalik said...

Equipment Qualification focuses on an individual piece of equipment, but you're disregarding a few key considerations which highlights the need for separate and different Validation approaches to these two areas of Validation.openit