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General information
Regulatory authorities require that companies producing therapeutic or diagnostic products must validate their production processes prior to production or analysis.
A validation process is complex and requires that certain steps are performed in a predefined and specific order. An introduction to this topic can be found under our Guidelines for Process Development. Our experience and long history of supplying chromatography systems, and now also membrane systems, to the pharmaceutical industry together with our knowledge of regulatory requirements, allows Fast Trak Validation™ to offer a wide range of documents and services that can help pharmaceutical companies reduce time to production start and lower validation costs.
We recommend that validation of equipment should consist of the following steps:
Read more in Validation documentation and services data file.
Explanation of flowchart keywords
Validation Plan. Specifies the validation steps and order thereof. The validation plan must also specify responsibilities and include a time plan.
User Requirements Specification (URS). This document specifies the "needs" of the production process, based on technical reports, production and cleaning methods, and regulatory requirements (i.e. cGMP and 21 CFR part 11).
Functional Design Specification (FDS). The purpose of this document is to define a system that meets the expectations and requirements as specified in the User Requirements Specification (URS).
System Quotation. This is the quotation from the system supplier that outlines the details including prices, delivery time, warranties, spare parts and education as agreed and specified in the Functional Design Specification.
The URS, FDS and System Quotation are also referred to as the Design Qualification.
Supplier Audit. It is recommended that a supplier audit be made to verify that the system supplier meets the demands as specified by the pharmaceutical producer. The audit will verify that the supplier's routines for development and production of the suggested software and hardware adhere to that required for using the system for pharmaceutical production.
System Construction. Based on agreements in the FDS and System Quotation, a system can be constructed by the system manufacturer/supplier. This is done according to the in-house SOPs and all documents required are either completed or created. In the last phase of the system construction, the system and all of its components are tested to verify functionality.
In cases when large and/or customized systems are constructed, a Factory Acceptance Test (FAT) can be performed. This verifies that the system meets the design and functionality demands while still at the construction site.
Installation and Commissioning. Unpacking the system and installation in the operating environment take place at the pharmaceutical production facilities. Commissioning follows installation, and can be described as a general system check to verify that all components work correctly after transportation and installation.
When the system has been commissioned, a Site Acceptance Test (SAT) can be performed. The purpose of a SAT is to verify that everything defined in the System Quotation has been delivered and that the system is complete, installed and operational. After completion/approval of the SAT, the formal responsibility for the system rests with the pharmaceutical producer.
Installation Qualification (IQ). An IQ is a detailed verification that all system components are in place, correctly installed, and the accompanying documentation is correct.
Operational Qualification (OQ). Performed after the IQ, the OQ will verify that all components and instruments work correctly according to the system specification, both as stand-alone and as part of the computerized system.
The IQ and OQ are also referred to as the Equipment Qualification.
Process/Performance Qualification (PQ). PQ is documented verification that the process consistently performs as intended in routine use in its normal operation environment, and consistently produces product of acceptable quality. PQ will also verify that the specific methods (production, cleaning, storage) work in the system. When the PQ is completed and approved, the system can be put into production and the validation process is complete. |
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