GMP
HIPP is committed to ensuring that its engineering designs follow current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) and approaches this commitment in several ways:
Training
Our lead engineers have an average of at least 20 years of work experience in designing cGMP and cGLP-type projects. Resumes can be provided outlining specific work examples.
We have launched an internal multi-faceted training program for all HIPP employees and design firm subcontractors. Program elements include:
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An introduction to the pharmaceutical industry, cGMP, FDA, EMA, and engineering guides
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An overview of proper cGMP attire, owning, and work attitude when working in cGMP facilities
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A discussion of pharmaceutical processing equipment and utilities, general applications, and cGMP issues associated with them
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Differentiating between direct and in-direct utilities and equipment, equipment/systems requiring qualification or validation versus systems requiring commissioning only
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Presentation and review of the HIPP change control procedure
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Presentation and review of commissioning as it relates to design and specification requirements within an engineering design package
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In addition, team members attend Owner-required training programs covering these subjects. Team members have received cGMP/GLP training at Eisai, DSM Pharmaceuticals, Novo Nordisk, Wyeth Vaccines, and Biogen, among others.
Designs
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Our designs follow the cGMP codes as set forth in the 21 Code of Federal Regulations. In particular, Part 11, referring to electronic signatures, and Part 211 Subpart C pertaining to buildings and facilities. Our designs also incorporate the standards and guidelines of the International Society for Pharmaceutical Engineering (ISPE).