Qualification and validation are two components of the same concept. The term “qualification” usually refers to equipment, services, and systems, while the term “validation” is used for processes .We support our customers in deciding on the strategy to follow in the qualification, either according to a traditional method or in accordance with ASTM E2500, analysing intermediate options based on scientific knowledge and risk assessment.
In the traditional method, the qualification of facilities, services and equipment covers the entire process, from the development of user requirements (URS) through risk assessment (RA), validation master plan (VMP), factory acceptance testing (FAT), site acceptance testing (SAT), design qualification (DQ), installation qualification (IQ) and operational qualification (OQ) to end up with performance qualification (PQ).
All deliverables (starting with User Requirements, URS) are focused on Product Quality Attributes (CQAs), Critical Process Parameters (CPPs) and Critical Design Elements (CDEs) as risk control measures, as well as regulatory aspects and the customer’s own quality requirements. All the tests that are conducted, both in the start-up (FAT/SAT/Commissioning) and in the validation, are designed to provide documentary evidence that the system complies with its foreseen use.
The strategies used to conduct the qualification activities will be forward-thinking and will aim to demonstrate that both the facilities and utilities have been designed, developed, installed, and operate according to specifications, so that they comply with the intended use according to user and regulatory requirements.
URS should be a benchmark throughout the entire validation lifecycle. It is the basic document on which all qualification documentation will be based to ensure full traceability throughout the validation lifecycle. We review and develop the URS to ensure that they clearly and accurately describe all the needs to be met by facilities and utilities, in terms of quality and quantity, defining the required functions, as well as the environment and operating parameters, in accordance with the requirements of Good Manufacturing Practices (GMP).
The essential elements of quality should be incorporated at this stage and any risk of non-compliance with GMP should be mitigated to an acceptable level. User requirements related to product quality should be based on product knowledge (quality critical attributes, QCA), process knowledge (process critical parameters, CPP), regulatory requirements, and organizational quality requirements.
The validation master plan defines in depth all the validation activities to be carried out, starting with establishing the strategy to be followed, organizational structure, responsibilities, expectations and of course the planning of the activities to be carried out in accordance with the pharmaceutical regulatory authorities (e.g. EU, FDA, TGA, etc.).
The validation master plan is a key document for the management of validation throughout the product lifecycle and should be considered a reference document for all related activities to ensure traceability and compliance with current regulatory requirements.
Quality risk management is incorporated into the validation lifecycle (within the framework of the ICH Q9 guideline of “Quality Risk Management”) and emphasizes patient protection by managing risks affecting product quality, patient safety, and data integrity.
The objective of these tests is to ensure that the most critical equipment in the system or specific components comply with the design requirements and the requirements previously established by the user in the supplier factory environment (FAT) first and finally in the site environment (SAT).
FAT/SAT protocols are part of the commissioning documentation system.
As part of this preliminary testing, the correct construction and installation of the system is verified in accordance with the specified detailed design, materials, and construction standards as well as other regulatory requirements. To ensure that the system, as it has been built, works according to the design criteria, the necessary functional and performance tests will also be conducted.
The design qualification protocol verifies that the system design has been conducted according to the user’s requirements in terms of product quality and GMP. It is at this stage that the user requirements regarding the design documentation of the equipment are fully verified.
The purpose of installation qualification is to ensure that the equipment/system has been installed or the installation itself conforms with the supplier’s recommendations as well as the description of the design specifications. It is verified that it is well documented in all relevant aspects and that it has been installed in accordance with GMP guidelines.
The IQ will include supplier’s tests and specific tests, depending on the results of the risk assessment.
The objective of the operational qualification is to verify that the operating parameters of the equipment/systems comply with the functional specifications and acceptance criteria in each case, according to the established test conditions, including limit conditions.
It will be based on the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) identified in the previous qualification stages and in critical aspects (CAs) or risk control measures derived from risk analysis.
The objective of the performance qualification is to verify that the operating parameters of the equipment/systems comply with the functional specifications covering the operating range of the intended process.
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