Qualification and validation should be performed:
- for new premises, equipment, utilities and systems, and processes and procedures
- when changes are made, depending on the outcome of risk assessment
- where necessary or indicated based on the outcome of periodic review
The equipment and utility qualification is based on a risk analysis.
Based on a risk analysis we determine:
- a scope of qualification
- list of tests
- control points
- sampling frequency and location
- frequency of the requalification
All qualification and validation activities a planned and take the life cycle of facilities, equipment, utilities, process and product into consideration.
The results of risk analysis are reflected in a validation master plan. The validation master plan is a document where key elements of qualification and validation programme are identified and documented.
Design Qualification is the key stage in the successful implementation of a project allowing identify gaps and assess risks at the design stage. The design qualification documentation can’t be performed by the organization performing design as this can lead to a conflict of interest. Design qualification (DQ) is a documented confirmation of suitability of the proposed design of premises, systems and equipment for intended use.
Design qualification should be performed for:
Design qualification has to demonstrate compliance with GMP requirements and the user requirements specification. It doesn’t include an assessment of the compliance with construction rules & regulations, rules for the operation of electrical installations and other requirements. We also provide services for assessing the compliance of the design with construction rules & regulations, electrical installation rules and other requirements, as well as assessing energy efficiency and logistics.
We conduct qualification of process equipment and utilities (HVAC, purified water, water for injection, pure steam, compressed air) in accordance with the validation master plan.
Qualification documentation should provide the evidence that equipment is working properly and meets expected results.
The qualification should include the following documentation:
- Design qualification (DQ) is a documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.
- Installation qualification (IQ) is a documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
- Operational qualification (OQ) is a documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
- Performance qualification (PQ) is a documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.
One stage of qualification should be successfully completed before the next stage is initiated, e.g. from IQ to OQ. In some cases, only IQ and OQ may be required, as the correct operation of the equipment, utility or system could be considered to be a sufficient indicator of its performance. Major equipment and critical utilities and systems, however, may require URS, DQ, IQ, OQ and PQ.
The qualification work consists of the following stages:
- development of qualification protocols
- preparation of qualification reports
As a minimum the qualification protocols have the following information:
- the objectives
- the site
- the responsible personnel
- description of the standard operating procedures (SOPs) to be followed
- equipment or instruments to be used
- standards and criteria as appropriate
- the stage of validation or qualification
- the processes and/or parameters
- sampling, testing and monitoring requirements
- stress testing where appropriate
- calibration requirements
- predetermined acceptance criteria for drawing conclusions
- review and interpretation of results
- change control, deviations
- archiving and retention
Qualification protocols should have a description of the way in which the results will be analyzed, including statistical analysis where appropriate.
Qualification and validation reports should:
- Be written reports on the qualification and validation performed.
- Reflect the protocols and procedures followed and include at least the title and objective of the study; make reference to the protocol; reference to the appropriate risk assessment; details of materials, equipment, programmes and cycles used; procedures and test methods with appropriate traceability.
- Results should be recorded and be in compliance with good data and record management practices.
- Results should be reviewed, analysed and compared against the justified predetermined acceptance criteria, interpreted and statistically analysed where appropriate.
- Results should meet the acceptance criteria. Deviations, out-of specification and out-of-limit results should be documented and investigated according to appropriate procedures. If these deviations are accepted, this should be justified. Where necessary, further studies should be performed.
- The conclusion of the report should state whether or not the outcome of the qualification and/or validation was considered successful, and should make recommendations for future monitoring and setting of alert and action limits where applicable.
- The departments responsible for the qualification and validation work should approve the completed report.
- The quality assurance department should approve the report after the final review. The criteria for approval should be in accordance with the company’s quality assurance system.
- Any deviations found during the validation process should be managed and documented. Corrective actions should be considered.
We provide qualification and validation services for:
- pharmaceutical facilities
- wholesale companies
- manufacturers of medical products
Our specialists have a high level of professional qualification, successfully cooperate and perform work for domestic and foreign companies, in particular, the largest players on the pharmaceutical market of the United States of America, the European Union, Turkey, Russia, Ukraine, Kazakhstan, Belarus, India, China.
We are glad to offer you the following services:
- Development of a general validation master plan
- Development of a validation master plan for manufacturing lines, warehouses, laboratories, computerized systems
- Utility qualification
- Process equipment qualification
- Laboratory equipment qualification
- Qualification of temperature-controlled storage areas
- Computerized systems qualification