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.
This procedure is applicable to validation sampling and testing for all new product introductions, and when changes to manufacturing procedures, manufacturing equipment, or raw materials warrant process validation.
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.
This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure.
The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks.
Excluded form this scope is filling of tablets and capsules and labelling and secondary packaging of all drug products.