FAT in pharmaceutical industry is performed at the equipment’s manufacturer facility to verify the equipment’s performance before transporting it to the buyer’s site.
FAT in pharmaceutical industry consists of a series types of acceptance tests performed at the equipment manufacturer’s facility before shifting the equipment to the buyer’s location. Its basic purpose is to verify the machine’s entire performance according to the agreed specifications. The equipment is operated in real-time, with actual operating conditions in the buyer’s facility.
FAT in pharmaceutical industry is an integral part of equipment commissioning. It helps to detect any shortcomings or problems with the manufactured equipment before being shifted to the buyer’s facility.
FAT in pharmaceutical industry is performed at the commissioning stage of the equipment life cycle. The position of FAT is after the planning and design approval stage. It is performed when the equipment has finally been manufactured by the equipment manufacturer before transporting it to the buyer’s facility.
FAT in the pharmaceutical industry is the first step of the commissioning stage. After performing and approving FAT, the next step is Site Acceptance Test – SAT, which is performed at the equipment’s buyer location.
What are the acceptance test criteria for FAT in pharmaceutical industry?
Acceptance criteria for the factory acceptance test in the pharmaceutical industry are the desired outcome from equipment. These are finalized during the design phase and are indicated in the User Requirement Specification document. The URS is a document against which acceptance criteria for entire commissioning and qualification activities are defined.
FAT in pharmaceutical industry is performed by
Commonly, FAT in pharmaceutical industry is performed by a team from the following departments.
Engineering department: they are responsible for critically analyzing the equipment and checking whether there are any design or manufacturing faults.
Quality department: the quality department is responsible for checking if any deviation is related to quality principles.
Production department: a representative of the department where the equipment will be installed. It’s best to include personnel with firsthand equipment operation experience, for example, machine operators or area supervisors.
Template for FAT in pharmaceutical industry
There is no fixed template for FAT in pharmaceutical industry. It depends on the mutual coordination of the buyer and manufacturer to decide on the FAT template.
Typically template for FAT in pharmaceutical industry consists of a tabular form with specific columns. The columns indicate the respective section as mentioned below.
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
The test is the desired test performed on the machine or a specific process . It also indicates a particular part, process, section, or function of the equipment to be tested.
Acceptance Criteria: it is the desired outcome of the test. Typically, it indicates the buyer’s requirements for which the equipment under test has been procured from the manufacturer.
Pass / Fail: This column indicates the success or failure of the test. If the outcome of the test fulfills the acceptance criteria, the test is considered a pass, and the same is indicated/written in this column. On the other hand, If the outcome does not fulfill the acceptance criteria, the test is considered a failure, and the same is indicated/written in this column.
Signature with Date: This column includes the signature of the personnel performing the test. Its main purpose is to make sure that the acceptance test is performed with full responsibility.
Checklist for FAT in pharmaceutical industry
There is a separate checklist for every piece of equipment,, and it depends on the specific process for which the buyer has bought the equipment.
Following is a generalized checklist for factory acceptance tests, which covers common equipment tests. You can take the checklist as per your requirement and omit those not required or included in your equipment.
Machine Capacity
In this test, the equipment’s working capacity is verified. It includes verifying that the machine can produce the output at desired speed or capacity. The output capacity can be termed in pieces/hour or the rpm.
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Operate the machine at the desired speed | The output pieces / hour should be ____
Or The output should be _____ kg/hour Or The machine speed should be ___ rpm |
||
| Output product condition | The output product should be in good condition without breakage. | ||
| Labeling | The labels at the product should be satisfactory without any
· Duplicate labels · Over glued labels · Under glued labels · Misplaced labels · Missing labels
|
Software
In this test, software systems are verified and checked whether the manufacturer has included all features for which the buyer has paid the price.
Some common test in this section includes the following.
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Login ID & Password | ___levels of password protection have been provided
Options of one level cannot be accessed by another level |
||
| 21 CFR part 11 | Software should follow the guidelines of United States FDA, CFR part 11 | ||
| Graphical data | All critical data ( provided by the buyer during design phase) should be graphically displayed | ||
| Data backup | Software is capable of backing up the data every after ____ time or user defined time |
Human Machine Interface – HMI
In this test, the Human machine interface is tested. It includes verification that HMI is installed according to the buyer’s requirements and contains all the functions, applications, and systems.
Some common tests related to HMI include the following
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Power Supply | HMI is powered-up by 24VDC/ 220VAC / 110VAC | ||
| Main screen | When HMI is powered-up, main screen appears | ||
| Touch Panel | Touch system works efficiently without any system hang
Touch panel is in satisfactory condition without any breakage |
Utility Connections
In this test, utility connections are verified. The main aim of this test is to make sure that the equipment is capable of providing the required performance at the specifications of the utility connection available at the buyer’s location
Some common tests related to utility connections are mentioned below.
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Steam | · Machine must operate satisfactorily at ___ steam
· Regulator for steam must be provided |
||
| Compressed Air | · Machine must operate satisfactorily at ___ bar
· Filter for oil must be provided
· Filter for moisture must be provided |
||
| Water | Machine must operate satisfactorily at ___ bar | ||
| Particular (Gas) | Machine must operate satisfactorily at ___ bar |
Instrumentation
In this test, all instrumentation system is verified. They are checked for accuracy and performance. It is also checked that the manufacturer has installed instrumentation for all the systems and processes as required by the buyer
Some common tests in the instrumentation includes the following
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Instrument
(temperature / pressure/ airflow / level / counter conductivity / TOC pH values / chlorine / etc. etc. |
The instrument must be properly wired without any losing in its connections and terminals. | ||
| The instrument values must be free of any fluctuations | |||
| instrument should measure and display their respective values of ___ process |
Materials of Construction
In this test, materials of construction for various parts are verified.
Some common tests in the instrumentation include the following
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Product contact parts | Product contact parts must be of SS316L | ||
| Non – product contact parts | Non product contact parts must be of SS304 |
Operating parameters
The equipment’s various operating parameters are checked and verified in this test. These tests are essential because output depends on the operating parameters.
Some common tests related to operating parameters include the following.
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Flow rate | The fluid flow rate should be _____ | ||
| Mixing speed | The mixing speed should be variable with minimum speed ______
And maximum speed _____ |
||
| Heating | The equipment must provide heating for temperatures up to _____ | ||
| Vacuum | Vacuum system must be installed
Vacuum system must provide vacuums upto |
||
| cooling | Cooling system must be installed
Coling system must provide vacuums upto |
Environmental parameters
The equipment’s ability to provide specific environmental conditions is checked and verified in this test. These tests are mostly performed for HVAC or its related equipment such as Cleanrooms and Pass throughs
Some common tests related to Environmental parameters include the following
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| Temperature | The system must provide temperature conditions in the range of _____ | ||
| Relative humidity | The relative humidity must be in the range of ______ | ||
| Particle Counts | The particle count must be in the range of _____ | ||
| Differential pressure | Differential pressure across ______ area must be in the range of _____ | ||
| Air change rate | Air changes must be in the range of _____ | ||
| HEPA filter | HEPA filter of class _____ must be installed at the ____area
Certificates HEPA filter must be provided |
||
Documentation
In this test, it is verified that the manufacturer has provided all the documentation. The documentation format is also approved and contains all the necessary information.
Some common tests related to documentation include the following
| Test | Acceptance Criteria | Pass / Fail | Signature with date |
| User Manual | Clear instruction for the equipment user indicating how to operate the equipment in a way that produces satisfactory prduct | ||
| Validation Documents | · Design Qualification
· Installation Qualification · Operational Qualification · Performance Qualification |
||
| Calibration certificates | · Material of construction
· Surface finish · HEPA filters |
||
| Software design specification | Should be provided | ||
| Hardware design specification | Should be provided | ||
| Drawings | · Equipment layout indicating installation requirements
· Process & instrument diagrams · Spare parts list · Electrical diagrams |
Operational Test
- After individual functions have been tested and verified, equipment is operated for a single cycle or any number of cycles ( as per agreement)
- In this test, actual production parameters are applied, such as temperature, pressure, and speed
- Define acceptance test for every equipment function and cycle
- Operate every single function or process parameter.
- Note down the result, as mentioned in the format above.
- Finalize the document with respective signatures.
Report for FAT in pharmaceutical industry
After completion of the FAT in pharmaceutical industry, a detailed report is prepared. Its main purpose is to document the entire FAT activity for record purposes and future follow-up.
There can be different formats for factory acceptance tests, but it is necessary to include all the relevant information and data in it.
Typically report for FAY consists of the following information and detail
- Deviation in the equipment design, working or in its output product
- Identification of corrective actions
- Responsibility of the equipment manufacturer
- Responsibility of the equipment buyer
- Corrective actions required
- Timeline of the corrective actions
- Timeline for next FAT or SAT