Pre-commissioning activities were completed at Aspectus Pharma facility

| By | Aspectus Pharma, Drug Manufacturing, GMP Standards, Pharmcontract
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Aspectus Pharma completed pre-commissioning activities for the entire range of technological and analytical equipment. The production facility prepares to undergo a GMP audit and obtain licenses for full-cycle manufacturing of modern, high-quality and safe drugs.

Pharmcontract Group of Companies, a leading Russian chemical and pharmaceutical holding company, completed the launch of this new pharmaceutical enterprise established just 2 years ago.

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The construction of new pharmaceutical plant included establishing a complex of chemical and biological laboratories that meet all manufacturing standards.

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The Distribution Department and Service Office of the holding company arranged the delivery and launch of equipment set for synthesis of pharmaceutical substances, and equipped laboratories for R&D, Microbiology and Quality Control departments in order to organize the full-cycle manufacturing.

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“Aspectus Pharma is a very young company established from scratch a little less than 2 years ago. Our partners helped us to achieve such rapid pace and record time for implementing the idea and project into an audit-ready enterprise,” said Valery Semenov, the Executive Director of Aspectus Pharma. “Among them, I would especially like to mention Pharmcontract Group of Companies. Its employees ensured the on-time delivery and launch of equipment set for synthesis of pharmaceutical substances and equipped laboratories for R&D, Microbiology and Quality Control departments. As an important aspect of collaboration for a newly established full-cycle enterprise, I would like to note the speed of preparing and approving URS. The representatives of the partner provided detailed specifications for reactor equipment, and ensured the implementation of SAT and FAT tests. Virtually all our employees worked very closely with the Service Office of Pharmcontract Group of Companies, which not only carried out IQ/OQ and pre-commissioning activities, but also provided individual training, methodologies and programs required in our day-to-day work. Overall, we were not just satisfied, but pleasantly surprised by such a high level of service combined with professionalism. Accordingly, our collaboration will continue, and we will recommend this company to our partners for performing similar works.”

SOURCE: gmpnews.ru
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