Validation and Qualification are essentially components of the same concept. The term ‘qualification’ is usually referred to equipment, utilities and systems, whereas the term ‘validation’ is used for processes.
Telstar can help customers to decide their qualification strategy, from a traditional approach to an ASTM approach.
In a traditional approach, qualification of facilities and equipment may include the whole process from User Requirement Specification, to Risk Assessment, Validation Master Plan, FAT, SAT, DQ, IQ, OQ and PQ.
The following shows all the qualification deliverables that Telstar can develop, indicating the documentation associated to each qualification step.
The following facilities, utilities and equipment can be qualified by Telstar:
The strategies to carry out qualification activities will be prospective, with the aim to demonstrate that facilities and utilities are designed, developed, installed and operate according to specifications, so that they meet the intended use according to user and regulatory requirements.
The URS should be a point of reference throughout the validation life cycle and should be supplied by the customer although Telstar can help to develop them according to the current standards.
The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. This can be achieved by categorizing the individual requirements in two groups:
The validation strategy, responsibilities, activities and deliverables must be defined at a high level by the Validation Master Plan. The objective of the validation program is to show that the production facilities, equipment, utilities and processes have been designed and built correctly and operate in a manner to meet the statutory and applicable regulatory requirements.
The objective of the Validation Master Plan is to present an overview of the entire validation activities that must be carried out. It will establish the strategy, organizational structure and planning of all activities to develop in compliance with pharmaceutical regulatory authorities, for example the EU, FDA, TGA, etc… This document will provide a detailed program of all validation activities that will be carried out, guaranteeing their traceability and compliance with current regulatory requirements.
The Validation Master Plan is a key document for the management of life cycle validation and should be considered as a reference document for all the related activities.
Quality Risk Management is incorporated into the validation life cycle, following the ICH Q9 framework for “Quality Risk Management”, with a focus on the protection of the patient by managing risks to product quality, patient safety and data integrity.
The objective is to ensure that the main equipment of the system, or specific components, first in the factory site (FAT) and later in its performance on-site environment (SAT), accomplishes the design and user pre-established requirements.
FAT/SAT protocols will constitute the system commissioning documentation.
As part of this preliminary check, the system’s correct construction and installation in accordance with the detailed design, specified construction standards and materials, and other regulatory requirements, are verified. In addition, to verify that the system, as constructed, will perform according to design criteria, some functional and performance tests will be also carried out.
Design Qualification is the main document where it is verified that the design of the equipment has been performed according to product quality user requirements and GMP requirements. It is the stage where user requirements are fully verified over the equipment’s design documentation.
The purpose of the Installation Qualification is to ensure that the equipment has been installed according to supplier recommendations as well as matching the description of the design specifications, it is well documented in all relevant aspects, and is installed according to the GMP regulations.
The IQ will integrate the supplier’s test and the specific tests, based on the results of the risk analysis.
The purpose of the Operational Qualification is to verify that the equipment operational parameters are within the functional specifications, and that they meet the acceptance criteria in each case, under the established test conditions, including limit conditions.
It will be based in the Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) identified in the previous qualification stages as well as in the critical aspects (CA) or risk control measures deducted from the risk analysis.
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