GMP Validation Certification
Good Manufacturing Practice abbreviated as GMP is the regulation of the highest standards of foods produced by a manufacturing company.
There is a fixed standard code of practices that must be followed by a manufacturer to be accepted as a manufacturer and distributor.
GMP certification means the proof or certificate which is given to the manufacturer for maintaining good manufacturing practices and the highest standards of services.
The following aspects are considered in this certification:
- Personnel Qualifications
- Process Validation
- Complaint Handling
- Record Keeping
- Equipment Verification
GMP is granted on various grounds that are based on the above-mentioned aspects. Some of these prominent protocols are discussed below:
Site Acceptance Test, abbreviated as SAT deals with the required and desired specifications of the site which is offered by the user.
The purpose of SAT is to make sure if the system will show compliance to the site of the application. It enables us to test the criterion for optimum results.
It reates with the Factory Acceptance Test known as FAT as well in the sense that the equipment meets or exceeds the criterion of the site.
The clients themselves write the SAT to verify the efficiency of the equipment.
The Factory Acceptance Tests are run at the factory before dispatching the equipment to the delivery address. The manufacturer, the client, and the client representative are involved in this process.
These tests are commonly done in medical, biotech, and Pharmaceutical fields and are a very necessary component of GMP certification. It is for the confirmation of all the standards required by the production of such products.
Requirements of SAT and FAT
- These must be monitored and recorded by a higher authority.
- There should be proper tracking of system software of different departments to ensure the credibility of the tests.
- The safety of the manufacturer and the operator must be ensured.
Industries like pharmaceutical industries, food processing units, biotech plants require accurate measurements to obtain precise results.
Any shortcomings in the equipment or lack the measurements can lead to deadly consequences.
Equipment validation is done through IQ, OQ, and PQ, which secure the performance of the application.
IQ stands for installation qualification, OQ stands for operational qualification and PQ stands for performance qualification. These are the specified terms for quality assurance protocols and are regulated by the FDA.
Installation Qualification (IQ)
It is a document that verifies the proper delivery, installation, and configuration of equipment according to the proposed standards. Sufficient energy supply, proper location, and environmental conditions are also checked.
Operational Qualification (OQ)
It ensures the quality of the equipment by verifying the optimum operation as listed by the manufacturer. All the aspects of the equipment are checked and assessed separately to check the performance range.
The significance of OQ is that there might be some requirement to make any modifications and maintenance which must be resolved as soon as possible.
Performance Qualification (PQ)
To make sure that the equipment is truly qualified, you need verification that the equipment is working in the range as promised under the given conditions.