Validating an hplc method

This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment.There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e.This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation.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.concurrent and prospective validation) and qualifications (OQ, PQ).This SOP defines the procedure for cleaning, passivating and derouging the purified water system at a GMP site.For full version of manuals and procedures please read more by clicking the "Subscribe" button on the left.

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.Our goal is to provide a complete GMP & GLP models with a set of ready procedures and manuals which are easy to understand and readily applicable.All procedures are written with practical instructions and examples.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 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.

Leave a Reply