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All procedures are written with practical instructions and examples.
Forms and templates are referenced in the SOPs where applicable.
This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose.
This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual.
This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file.
This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure.
This policy applies to all production process used for manufacture of commercial drug products or in-process materials for commercial drug products.
Excluded form this scope is filling of tablets and capsules and labelling and secondary packaging of all drug products.
For full version of manuals and procedures please read more by clicking the "Subscribe" button on the left.This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented.The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies.This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required.Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria.The plan pertains to the qualification of processes and laboratory equipment.The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing required for the validation of the facilities and utilities that are involved, directly or indirectly, in the manufacturing processes at a GMP site.It defines the responsibilities within the trial process and documents that need to be considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements.This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment.This validation guideline describes the approach and methods which will be used for the qualification of equipment at a GMP manufacturing site.The aim of this validation guideline is to provide a clear statement of the scope, validation approach and testing requirements for the validation of the equipment that is involved, directly or indirectly, in the manufacturing and testing processes.