From a practical point of view of a program of Quality Assurance of a pharmaceutical laboratory Stabilities Master Plan and Master Plan Validation form two critical parameters to ensure the effectiveness, safety and safety of products manufactured by VECOL.

For this reason, once evaluated the methods of analysis performed on raw materials and finished products are deployed every finished product that can be analyzed by HPLC should be approved this technique.

This recommendation was implemented in the aforementioned plan of the administration of the 90's by reducing costs. A large majority of the products are analyzed by the spectrophotometric method, which undoubtedly is an economical method, but unfortunately the information is timely, serves only as a product is analyzed before releasing to market. But if one seeks to know what happens to the product shelf time, this analysis is of no use.

Therefore, in this time period, what has been done is to develop and implement techniques for HPLC analysis for all products. Also, preliminary stability tests subjecting new or existing products to validate the analysis techniques and once you have established the methodology will begin developing protocols for product stability. You are currently in the final stages of writing the Plan Stability and stability of some protocols.
In support of this plan is being developed Stabilities Validation Plan, which in one of its modules is developing the procedure for validation of analytical techniques.