The validation of laboratory instruments is a critical aspect of ensuring the reliability and accuracy of data generated in any laboratory setting. A robust validation process provides documented evidence that an instrument performs as intended, consistently and reliably, within its specified operating range. This article provides a detailed guide to the validation of laboratory instruments, covering key aspects from initial […]
1.0 Purpose This SOP defines the validation process, encompassing the philosophy, responsibilities, procedures, documentation requirements, and revalidation program, to ensure consistent production of products meeting pre-determined specifications and quality attributes. 2.0 Scope This SOP applies to all validation activities related to new and existing equipment, processes, and systems within the manufacturing facility. 3.0 Definitions Validation: Establishing documented evidence that provides […]
Introduction Within the pharmaceutical industry the Validation Master Plan serves as a fundamental document which describes the entire approach toward validating equipment and systems with regulatory requirements in mind. Pharmaceutical warehouses depend heavily on Validation Master Plans to protect pharmaceutical product integrity throughout storage processes as these systems enable product quality and safety inspections before distribution to consumers. One vital […]
Introduction A Validation Master Plan often abbreviated as the VMP provides an extensive description of the principles that are related to the qualification of a particular facility. It defines which systems and areas need validation and provides a comprehensive plan of how to become, and remain, a qualified facility. In other words, the VMP simply translates the validation strategy down […]
