Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
The qualified person (QP) is the person(s) among key manufacturing and quality personnel responsible for GMP compliance and the release of every batch of final products. A person who meets educational and experience requirements detailed in EU Directive 2001/83/EC. All holders of manufacturer's authorizations in the EU must have at least one QP permanently and continuously available. QP release is required for each batch of product sold or used in a clinical trial in the EU.
Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use and that the quality systems are maintained.
Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
Document specifying the quality management system of an organisation.
Overall intentions and direction of an organisation related to quality as formally expressed by senior management.
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
A quality system is the organizational structure, responsibilities, procedures, processes and resources for implementing and continually improving the quality.
An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.