appropriate skills are maintained and that procedures are followed. Competency
assessments should be performed according to a formal plan that includes acceptable
performance standards and remedial measures.
c. The QA unit should monitor the effectiveness of the training program and
1-4. EQUIPMENT AND INFORMATION MANAGEMENT
a. Vendor Approval and Product Certification.
(1) QA unit is responsible for auditing vendors to ensure that equipment and
supplies are manufactured according to cGMP.
(2) Manufacturer should provide document stating conditions under which the
product was tested.
b. Installation Qualification.
(1) The manufacturer establishes protocol for installation that includes
electrical, water, space, and temperature requirements. Components of the system
include hardware, software, network, and user.
(2) Vendor installation must meet QA unit requirements for testing,
documentation, and acceptance.
c. Validation. Validation involves establishing documented evidence that
provides a high degree of assurance that a specific process consistently produces a
product that meets its predetermined specifications.
(1) Validation plan must include all parts of the process, such as interfaces,
data transfer software, modems, SOPs, and adjacent processes.
(2) QA unit should review and approve validation plan and results, and
determine whether new or modified processes and equipment can be implemented
based on these results.
d. Calibration and Preventive Maintenance (PM). Calibration and PM should
be performed on regular schedules and results should be within established acceptable
e. Quality Control (QC). QC results are used to determine if critical control
point practices are within the established range of acceptability.