FAT in GMP: AN IMPORTANT STAGE IN THE INVESTMENT PROJECT TO DEVELOP A PHARMACEUTICAL FACTORY
Vietnam's pharmaceutical industry is a promising market in Asia with increasing demand thanks to growing population, improved incomes, increasing urbanization rate and other environmental conditions.1
In order to meet the increasing demand, many large domestic and foreign pharmaceutical manufacturing enterprises have been investing in upgrading their factories, in order to break through and develop new pharmaceutical products to improve the quality of drugs and the ability to access to the community. However, procurement stage for production equipment always poses a significant challenge to any project team. The question in each project’s member is how to get the best equipment, all risks in future production must be strictly controlled to ensure quality of finished products supplied to the community.
In order for the output product to be safe, meet the standards, limit recall errors and optimize resources. Tien Tuan understands that instead of hoping for the best -we plan for the best.
Factory Acceptance Test – What is FAT?
Factory Acceptance Test – FAT is a set of predefined and planned tests to demonstrate fitness for the intended use requested by the customer, performed at the Supplier's factory prior to shipment.
A typical FAT involves customer representatives who are on site for 2–3 days (or more). The personnel involved can vary, depending on product specifications and project goals, and will generally include: production, QA, M&E, to confirm that equipment is manufactured in accordance with the design and expectations of the customer.2
The main components of a FAT program
- The FAT process is based on a pre-approved plan and protocol.
- The FAT report clearly states PASS or FAIL for each test case.
- In case any test fails, the content will be recorded and mentioned in the meeting after the FAT, then the two sides discuss and give opinions and remedies.
Since the COVID pandemic, FAT operations have gradually shifted to online or online combined with fieldwork with multiple connection points to maximize observations and records in terms of equipment quality at the same time.
The position, role and benefits of FAT in the project implementation process
Acceptance at the factory not only benefits the buyer but also the equipment supplier. For equipment suppliers, correcting technical issues while the system is at the factory minimizes cost and time significantly.
For example, when a blister size part of a Blister packaging machine is found to be unsuitable during the FAT process, resulting in failure of leak test, the equipment manufacturer can immediately investigate the cause, repair within one day. If there is no FAT, this error is detected at the place of use, it will take time to travel for experts, costly test materials, human resources, and utilities from the buyer. From there, it needs huge resources to correct a minor technical error.
Flowchart 1 3
For the purchaser, according to the above GAMP5 recommendation flowchart, FAT is performed upon completion of the Design Qualification, when the equipment is fully fabricated, to determine if the equipment fully meets its expectations or not.
After FAT is successful, the device will be dismantled for delivery. At the user's factory, the equipment is completely reinstalled and the acceptance test is performed at the site of use, this process is called the Site Acceptance Test (SAT)
Ergonomics survey in FAT makes the SAT process more convenient
Full FAT documentation makes it easy for SAT Acceptance, quality assessment, and ongoing monitoring.
The machine will then undergo additional Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to demonstrate that user and regulatory requirements have been fully satisfied, GMP risks are well controlled prior to commencing production of trial evaluation batches.
IQ tasks such as checking manufacturing materials, equipment drawings, checking utilities, etc. are also reviewed in FAT.
+ Check manufacturing materials to help detect and limit risks if machine parts suitable for use
+ Check diagrams and drawings to ensure that equipment parts are manufactured and assembled according to the original design.
+ Check energy sources such as voltage, compressed air, chilled water, ... to ensure the operating conditions for the equipment.
Check compressed air supply during FAT at TTP
OQ Operational Qualification is the documented demonstration that equipment components operate in accordance with established standards and that all performance parameters are within specified limits of the approved design. Standard Operating Procedure (SOPs), maintenance, calibration, and cleaning will also be developed during this phase.
Alarm check and Product run parameter setting in FAT at TTP
Setting the product run parameters on placebo during the FAT process also facilitates the OQ process to take place more smoothly.
In short, the process of implementing FAT has significantly shortened the time for the later stages of the project, helping to speed up the progress as well as strictly control risks and contribute significantly to the success of each project.
References:
1 Comment from Vietnam Briefing site.
https://www.vietnam-briefing.com/news/vietnams-growing-pharmaceutical-industry.html/
2 2008 - ISPE's GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
3 Pharmaceutical Engineering Home. ISPE. (2023, January 1). Retrieved January 13, 2023, from https://ispe.org/pharmaceutical-engineering
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