Customer Validation Support
Equipment validation is one of the most important requirements for manufacturers of pharmaceutical and veterinary products. The data obtained as a result of validation inspections, allow establishing that the production processes, implemented on the installed equipment, pass in a proper manner. The result of such inspection is a set of qualification and verification documents (protocols) confirming the compliance of the specified quality of the products produced at each technological stage, which is a necessary condition for obtaining GMP, GPP certificates and a number of other international certificates.
Alongside with manufactured and supplied equipment, “AURORA” provides a complete set of validation protocols confirming our compliance with all necessary procedures in the design, production and commissioning processes to the customers. Products manufactured by our company (filling, washing, mixing, capping, labeling machines) are supplied with all established FAT test protocols, SAT testing and other qualification tests included in the IQ and OQ documentation. In addition, the package of documents includes electrical diagrams, operating instructions, declarations of conformity, safety documents, lists of consumables and a number of other materials.
All supplied equipment is completed with certificates that confirming:
• compliance with the pharmacological requirements of all caprolon, rubber and metal equipment materials that have direct contact with the product;
• quality of body (welded) seams of equipment and its components in contact with the product;
• qualification level of the specialists who made welding of equipment parts;
• quality of all parts of equipment purchased from third-party manufacturers (as well as their drawings and diagrams).
The availability of this documentation allows our customers to successfully complete all the procedures associated with the validation and certification processes. Also this documentation is confirmed that the technological process of the production of products, in which the equipment supplied by us is used, functions in full compliance with the requirements and stated capabilities. We implement an absolutely transparent interaction scheme at the stage of validation support, which allows the Customer to control all production processes - from the development stage of the technical specification and design to the commissioning and output of equipment to a given capacity.
