The Difference Between a FAT and a SAT

It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and how in your next interview you will know exactly why each one is required. Any project that involves equipment being developed from a third party should have a FAT and SAT incorporated into the system life-cycle.

If both the FAT and SAT are performed correctly is will lead to a much easier IQ/OQ process.

 

What is a FAT

A FAT or Factory Acceptance Test is usually preformed at the vendor prior to shipping to a client. The vendor tests the system in accordance with the clients approved test plans and specifications to show that system is at a point to be installed and tested on site.

It’s an essential aspect of the whole system lifecycle and should be performed by experienced personnel. Time spent doing a proper FAT will lead to fewer problems when the equipment is installed on your site.

ISPE verdict:

The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricator’s site.

Publication Source: ISPE Biopharmaceutical Manufacturing Facilities Baseline® Guide

GAMP verdict:

Factory Acceptance Test (FAT): (IEEE) An Acceptance Test in the Supplier’s factory, usually involving the Customer.

Publication Source: GAMP 4, Good Automated Manufacturing Practice Guide for Validation of Automated Systems

On acceptance of a FAT some items to look out for include:

  • Performed FAT Protocol
  • Maintenance and User’s manual
  • Recommended spare parts list
  • Certificate of compliance
  • As built technical drawings (electrical, mechanical, pneumatic & process schemes)
  • Materials certificates/data sheets
  • Main equipments data sheets
  • Instruments calibration certificates
  • Welding Processes qualification

What is a SAT

A SAT is a Site Acceptance Test the system is tested in accordance to client approved test plans and specifications to show the system is installed properly and interfaces with other systems and peripherals in its working environment.

ISPE verdict:

Inspection and /or dynamic testing of the systems or major system components to support the qualification of an equipment system conducted and documented at the manufacturing site.

Publication Source: ISPE Commissioning and Qualification Baseline® Guide (March 2001)

Below is a list of some items that should be considered when performing a SAT:

  • Finishing Visual check
  • Main components visual check
  • Internal box pressure and ventilation setting
  • Utilities functionality and setting check
  • Functionality/Interlocks Verification (Mechanical & Software)
  • Safety devices and interlocks check
  • Operator’s training

6
shares

  • Sotofx

    As important a URS with clearly defined requirements.

    All verifications should satisfy the intended project needs.

    Industries should not find a URS document less important

  • Very good explanation of the differences

  • alex

    According to this article – Can one consider SAT as actually the “commissioning ” process ?

  • gtf

    A SAT does not necessarily take part of the life cycle process. It cannot substitite the IQ, OQ, PQ documentation. For the aroval of a software a FAT, SAT document cannot substitite the qualification and validation documentation.

  • Koushik Rajaram Nijagal

    Nice explanation, could have been better if given a detailed explanation with an example viz a major processing equipment with the team involved in testing both FAT and SAT, checking against what document, who prepares this master document and who approves etc.

  • S.Vijay kumar

    Your Comment FAT includes broader utility functions which may not be performed either during SAT or OQ.
    For viz the reactor may be provided with VFD for running at different rpm but the application part will be run
    at constant rpm to get the desired quality of the product.This is generally applicable for equipment designed for multiproduct services.

  • joao

    I believe FAT, can anticipate IQ/OQ, and so contibute to fast start on costumer site.Any one can inform if FDA agree with this?

Similar articles:

An Alternative View of the ICH Q10 Pharmaceutical Quality System (PQS)

The image below is that depicted by the International Conference of Harmonisation (ICH) Q10, Annex 2, and is supposed to depict a PQS or Pharmaceutical Quality System.

Typically, I really love the ICH. When we have to deal with outdated regulations from different global organizations it becomes a real nightmare trying to keep track of the nuances and the ICH has done a pretty good job of bringing several of the key organizations together and aligning them on how best to organize and meet the expected requirements.

That being said the diagram below and the depiction in Q10 of what a PQS should look like is greatly lacking.

Development Phases

In section 1.8 under the Quality Manual the ICH Q10 guidance states, “The description of the PQS should include: …(c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies.

Process maps and flow charts can be useful tools to facilitate depicting the pharmaceutical quality system processes in a visual manner”.

I completely agree.

The problem is using the graphical depiction they present in Annex 2 is completely worthless.

Basically they listed some of the PQS elements in a bar and then said they all apply to the entire product lifecycle, which simply isn’t true.

When we are in the development phase of our product lifecycle why would we do that under the change management system, or monitor process performance?

 

Controlling Change – No Value Add

There is no point in controlling changes for a product that is purposely being changed, nor does it offer any value to monitor the process performance for a process that has yet to be developed.

This isn’t a graphic depiction of the PQS, but rather a graphic of how they depict the lifecycle management (which also has some issues).

The PQS is the quality system and its subsystems and how they interrelate.

While it’s useful to look at how the PQS and product Lifecycle Management overlap and what elements of the PQS system are relevant at each lifecycle stage, it is not the point of the PQS, and even if that’s the end goal it’s not depicted here at all.

This image offers almost no value.

A Better Approach

So, what should this graphic look like?

While this is not a perfect view of a PQS, I would propose that the image below is a much better depiction of how the PQS should be visualized and a good place to start.

At the core of any quality system should be management. This goes back to Deming, who said, “Quality begins with the intent that is fixed by Management”.

Quality has to be rooted in the executive management team.

Define Core Quality Systems

Core quality systems then need to be defined. These are systems that impact all aspects of the business and include a Risk Management Policy, Resource Management, Document Control and CAPA systems.

All of the other subsystems, Deviations, Supplier Management, Equipment Qualifications, Validation, Material Management, etc, etc. all should be risk based or involve risk assessment, they all require resources and training, they call require documents (procedures, policies, records), and the CAPA system of course drives for process improvement regardless of the process.

Subsystems

All subsystems feed back into the main Management module. The subsystems listed, all are interconnected, with the exception of Post Market Systems.

The subsystems are important too, but they are farmed out to different groups and have different levels of importance depending on the stage of the product lifecycle.

Post Market Systems

The one exception is the Post Market Systems. This includes complaint management, product reviews, recall processes and other systems to support marketed products.

These generally do not interact with the other subsystems unless it is through the CAPA system or other management functions, but still utilizes all the systems under the management umbrella.

Alternate View

The PQS presented here, isn’t intended to be perfect, but I thought it was worth presenting an alternate view to the one presented by the ICH.

The ICH concept is a good one, and the ideas are fairly well laid out in the ICH, but the graphical representation of the PQS leaves a lot to be desired.

When establishing a PQS, it is better to start with something to what we’ve depicted here, and customize it as needed for the organization.

0
shares

Similar articles:

How 21 CFR Part 11.3(7) Applies to Electronic Batch Records [Video]

When dealing with Part 11 it’s important to understand what an electronic signature actually means

The definition of electronic signatures or e-sigs can be found in 21 CFR Part 11.3(7).

Electronic Signature

An electronic signature or e-sig means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Handwritten Signatures

We also need to understand what a handwritten signature means in the context of Part 11.
The definition of handwritten signatures can be found in 21 CFR Part 11.3(8).

Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.

The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

Electronic Batch Records

Eric works in a Pharmaceutical company and he is responsible for the filling process of the batch been manufactured.

Each time Eric performs the filling process he has to populate a batch record with the appropriate details

After each step Eric must also fill in his signature and date to verify that he actually performed each task.

Eric is manually handwriting these details and they are legally binding to Eric.

21 CFR Part 11.3(8)

This is when 21 CFR Part 11.3(8) applies.

Fast forward 12 months and Eric’s company has implemented a brand new Manufacturing Execution System (MES) where all details around the batch manufacturing process are recorded electronically.

21 CFR Part 11.3(7)

Now when Eric performs the filling process he now populates everything electronically and signs with his username and password combination to verify that he has performed those tasks.

This is when 21 CFR Part 11.3 (7) applies.

0
shares

TOP

Similar articles: