Laboratory controls shall include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of: identity, strength, quality and purity.
An extract from the FDA Compliance Program Guidance Manual says that: Laboratory equipment and procedures must be qualified and validated.
Within the validation programme lies the whole area of qualification testing which is carried out at predefined intervals and sets out to show that the equipment has been installed and operates or performs to the manufacturer’s requirements or specifications and is suitable for its intended use.
The following somewhat simplistic schematic of the qualification programme shows the relationship between the stages of qualification testing and validated use.
The first stage of the qualification testing is known as pre-purchase qualification, which is the user’s formal functional qualification. Commonly called a User Requirement Specification (URS), this document lays down the requirements for intended use including application and environmental requirements.