Abstract

HERRERA-GALAN, Michael  and  DUANY-ALFONSO, Yoenia. Processes validation with initial analysis of criticality applied to obtaining the active ingredient policosanol (PPG). Rev. colomb. biotecnol [online]. 2017, vol.19, n.1, pp.124-132. ISSN 0123-3475.  https://doi.org/10.15446/rev.colomb.biote.v19n1.50002.

Identifying the assets that will be submitted to the validation process is a priority task for any company that implements a Quality Management System, wicth has a direct impact on the success of any company. Taking into account the previous approach, it was designed in September 2014 a procedure in the department of Quality Assurance, Production Management, CNIC; with the aim of identifying those equipment or auxiliary systems that will be included in the validation process in the manufacture of the active ingredient Policosanol (PPG). To meet the principal goal, it was used a method based on the combination of techniques traditional risks such as comparative methods, fault logic diagrams, risk studies and operability, analysis of failure modes and effects, and others. As a result, it was obtained a general procedure for the implementation of the technique of criticality, it was named HAZID (HAZard-IDentification), based on risk analysis. As a fundamental conclusion, it was obtained a starting point to justify the inclusion of an equipment or auxiliary system to the validation process.

Keywords : Validation; criticality; management; risk; policosanol.

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