Verification of the degree of compliance with Good manufacturing practices and Good laboratory practics (GMP, GLP) for medicinal products, according to local or regional standards dispositions (ANMAT, MERCOSUR ) or international disposition (FDA, EC, WHO).
Preparation for audit of pharmaceutical plants, analytical laboratories, and distributors.
Evaluation of third parties and suppliers of production inputs.
Previous audits inspections of official or private, local, regional or international organizations. Assistance in the preparation of the plan of corrective actions and its execution according to program.
• Design of Master Plan (VMP) validations.
• Validation of manufacturing of all types of pharmaceutical forms, validation of cleaning procedures.
• Validation of analytical methods.
• Validation of systems of procurement, distribution and control of drinking water, purified water and water for injection.
• Records of production and packaging.
• System design of procedures operating standard.
• Design of studies of stability Statistical process Control.
• Process deviation/CAPA system.
• Claim management.
• Risk management system documentation
• Qualification of suppliers of raw materials, packaging materials, third parties, several service.
• Registration and transfer of products.
• Drafting of contracts.
Translation of technical documents.
Languages: English - Spanish - Portuguese.
GMP evaluation for plant design. Pharmaceutical water system.
Preparation of Master Plan for qualification of machinery, production lines and equipment for control of quality.
Preparing technical report, site master file based document issued by PICs, to issued instructions for the ANMAT. This document is prepared with the information provided by and/or relieved on the client.
So that it is not only a valuable regulatory document but that adds value to the operation of the company.