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
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
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).