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

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.

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Validation master plan

According to GMP requirements, manufacturers should plan qualification and validation within a product lifecycle. Any changes in the facilities, equipment, utilities and process affecting product quality should be formally documented and the impact on validated status should be assessed. Critical computerized systems should be validated.
The validation master plan is a document where key elements of qualification and validation programme are identified and documented.

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Development of the user requirements specification (URS)

URS is the user requirements sufficient to create a feasible design meeting the intended purpose of the system.

The user requirements specification (URS) and the functional specification define the characteristics of the equipment, rooms, support systems or other systems. At this stage, it is necessary to lay down the basic elements of quality and to reduce any GMP risks to an acceptable level. The User Requirements Specification (URS) should be a point of reference throughout the validation life cycle.

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Design Qualification

Design Qualification is the key stage in the successful implementation of a project allowing identify gaps and assess risks at the design stage. Design qualification is a documented confirmation of suitability of the proposed design of premises, systems and equipment meeting intended purpose.

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Utilities qualification

All direct impact utilities (affecting product quality) have to be:
- properly designed
- qualified
- carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products
- adequately monitored

The direct impact utilities are:
- clean rooms and HVAC
- purified water
- water for injection
- pure steam
- compressed air and nitrogen

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Process equipment qualification

Qualification documentation should provide the evidence that equipment is working properly and meets expected results. We conduct qualification of process equipment in accordance with the validation master plan.
Typically qualification consists of the following stages:
- design qualification
- installation qualification
- operational qualification
- performance qualification

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Laboratory instrument qualification

To ensure the appropriate accuracy and reliability of the quality control results, it is necessary to conduct qualification of critical lab equipment. Critical utilities that affecting quality control results must be qualified.

The following documents should be available in the quality control laboratory:
- calibration protocols
- qualification/requalification reports
- records on instrument maintenance

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Qualification of temperature-controlled storage areas

Appropriate storage condition should be envisaged on the stage of a design. Storage areas should be clean, dry and maintain the required temperature. If special storage conditions are required such as temperature, humidity they have to be envisaged, checked and monitored. Critical utilities should be qualified.

During qualification of warehouses, it is necessary to carry out temperature distribution test (mapping) that confirm the necessary storage conditions in critical season periods (the warmest and coldest ones).

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Risk based approach

We recommend applying a risk management approach to quality throughout the product life cycle. Within the framework of the risk management system for quality, decisions on the scope of qualifications and validation should be based on documented risk assessment. Risk assessment should be performed for:
- risks of cross-contamination and mix up
- products
- production lines
- premises, equipment and utilities

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