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Manufacturing: The Invention’s Implementation
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The entrepreneurial spirit of Pisgah Labs is practically expressed in its commitment to manufacturing excellence. Whether contract manufacturing or implementation of the Company’s platform technologies, Pisgah’s financial success and client / licensee prosperity is dependent upon predictable manufacturing. Pisgah Labs is an FDA inspected drug substance manufacturing facility operating according to current Good manufacturing Practices (cGMPs). The facility is also registered with the DEA for the manufacture of Schedule III – V controlled substances and for R&D activities for Schedule II materials (narcotics).
The manufacturing facility has capacities ranging from glassware through 2000 gallon equipment. The fully validated reactor trains are designed according to a suite concept wherein each suite is maintained as a controlled environment with dedicated HEPA filtration. The three multi-purpose suites accommodate the variable needs of a dynamic marketplace. Multi-ton large scale manufacturing is available whereas extensive or lengthy syntheses are typically accomplished in medium sized equipment in a separate suite. Finally, aseptic API manufacturing is available at the 50 gallon scale, or if needed, the design features of the larger equipment suites are available for, and capable of, aseptic validation.
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Production supervision and QA oversight are rigorously monitored for compliance to cGMP standards through written SOPs, protocols and batch sheets. Production documentation, particularly during a project’s validation stage is thoroughly integrated with the development process to meet the requirements for successful regulatory submissions (DMFs, ANDAs and / or NDAs). Our approach has produced a successful FDA compliance history covering continuous compliance audits (cGMP) and Pre-Approval Inspections (PAI).
Manufacturing is a core competency at Pisgah Labs and is considered an integral part to the implementation of a successful business strategy employing proprietary technology. In the highly competitive pharmaceutical industry, clients welcome the secretive and confidential stature afforded their projects in Pisgah’s facility. Similarly, the value of proprietary technology and “know how” are retained and protected so as to render the best financial return.
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