The definitions given below apply to the terms used in these guidelines. They may have different meanings in other contexts.
The performance of tests and retests to ensure that measuring equipment (e.g. for temperature, weight, pH) used in a manufacturing process or analytical procedure (in production or quality control) gives measurements that are correct within established limits.
The final review and formal approval of a validation or revalidation, followed by approval of a process for routine use.
challenge tests/worst case
A condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, that pose the greatest chance of process or product failure when compared with ideal conditions.
The performance of tests to ensure that the installations (such as machines, measuring devices, utilities, manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.
1 For the purpose of this Annex, "manufacturing process" is used as a synonym of "production process".
The transformation of starting materials into finished products (drug substances or pharmaceutical dosage forms) through a single operation or a sequence of operations involving installations, personnel, documentation and environment.
Documented verification that the system or subsystem performs as intended over all anticipated operating ranges.
qualification of equipment
The act of planning, carrying out and recording the results of tests on equipment to demonstrate that it will perform as intended. Measuring instruments and systems must be calibrated.
Repeated validation of an approved process (or a part thereof) to ensure continued compliance with established requirements.
The collection and evaluation of data, beginning at the process development stage and continuing through the production phase, which ensure that the manufacturing processes - including equipment, buildings, personnel and materials - are capable of achieving the intended results on a consistent and continuous basis. Validation is the establishment of documented evidence that a system does what it is supposed to do. Other definitions also exist, e.g. that given in the guidelines on GMP for pharmaceutical products (7, page 22).
validation protocol (or plan)
A document describing the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process - or a part thereof - for routine use.
A document in which the records, results and evaluation of a completed validation programme are assembled. It may also contain proposals for the improvement of processes and/or equipment.