Validation
CostaricaPharma will help to evaluate the suitability of products, equipment, and machinery. Costarica provides expert and objective assessments that help ensure that strengths are recognized and weaknesses are addressed.
Costarica offers strategic advice and first-class tactical support through services, including programs like assistance, validation/qualification activities, and computer system validations/Computer Software Validations(CSV). Validation Gap Analysis is generally the first thing that a Validation Engineer should do when meeting a new client. Ensuring that all discrepancies have been identified and agreed upon within the company. If an existing problem is not detected, not recognized and not resolved, and the regulatory body detects it, problems can be, and very often, harmful to an individual’s career and to the company.
Performing an audit gap analysis to a large extent ensures that the verification and compliance requirements of the company are met. Validation gap analysis tools allow you to systematically challenge company policies and procedures for complying with cGMP, comparing them with expected regulatory standards and allowing you to list all offenses. As long as you cannot highlight the shortcomings of the company, you cannot cover the task of fulfillment. Collecting resources for an immeasurable task is really difficult and almost impossible.
Types of Validation:
Analytical Method Validation:
Analytical Method Validation is used only for a specific test which is to be carried out on a specific basis. This Validation is applicable only
Equipment Validation :
Equipment Validation will provide high-level documented proof or Evidence that the equipment and the process confirm to be standard
Cleaning Validation :
Cleaning Validation ensures that there is no cross-contamination in a multi-product manufacturing unit and also eradicate microbial contamination.Once the product is manufactured, the equipment is cleaned using appropriate cleaning SOP’s established during the IQ of the equipment.
Process Validation :
Process Validation is a means of ensuring and providing documentary evidence that processes are capable of repeatedly and reliably producing a finished product of the required quality.
