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Preventative Quality
First and foremost, our team will always honor your non-disclosure-agreement. This Category focus on those actions needed to fill the non-compliance gaps. GMP training occupies a focal point here and we also highlight the importance of building up a good set of procedures and specifications to cover all production processes from receiving components to shipping finished products, quality assurance and control of critical points, and the testing methods and proper instrumentation to achieve such control.
GMP Compliance
We can help you build a fully GMP-compliant manufacturing plant, a modern GMP laboratory, efficient Quality Systems, or simply cover your basic GMP training. Our team can also review your customized pre-formulation and formulations of OTC, generic drugs, dietary supplements, and cosmetics. Formula review will focus on targeting, for example, prohibited or restricted ingredients to use in cosmetic products, safe markers to use in dietary supplements for process validation purposes, formula stability and potential improvements, scale-up process, etc.
Some of the services that our group provide in this Category are:
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GMP Training
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Implementation and Enhancement of Quality Management Systems.
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Change Control
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Vendor/Supplier Qualification
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IQ / OQ / PQ
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Stability Studies Design
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Implementation of Quality Control laboratories and Quality Assurance Programs
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Review of incomplete and complete formulations of OTC, generic drugs, dietary supplements, and cosmetics.
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Customized Testing Methods Development, Training and Validation of Laboratory Techniques such as: HPLC, X-Rays, Thin-Layer-Chromatography (TLC), Total Organic Content (TOC), product/material identification via FT-IR, Microbiology, viscosity, DNA fingerprinting, etc.
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Label Design and/or Revision
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Critical Points Analyses (i.e., HACCP)
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Review of Production Documentation (Master Manufacturing & Packaging Records, receiving and shipping records, logbooks, etc.)
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Writing of Standard Operating Procedures (SOP)
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Enhancement of Written Communication System (projects, protocols, reports)
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Writing and/or Review of Specifications (including Raw Materials, Packaging Components, Labels, and Finished Products)
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Preparation and Submission of Applications (i.e., FDA submissions (company, products, medical devices, ANDAs, NDAs), National Organic Program (NOP), Health Canada, etc.)
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Training (…repeated on purpose! … It’s IMPORTANT!)
