Pharmaceutical cGMP Consulting Services
Pharmaceutical cGMPs inspections may cover some or all of the following systems requiring compliance with cGMPs stipulated in 21 CFR part 211 for Finished Pharmaceuticals or APIs, depending on the scope of your needs or remediation. This may require following the GMP guide “ICH Harmonized Tripartite Guideline for Active Pharmaceutical Ingredients Q7” and a review of your firm’s systems and processes such as those listed below:
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Quality System,
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Materials system,
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Facilities & Equipment systems,
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Production system,
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Packaging & Labeling system,
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Validation/qualification system,
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Laboratory control system
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Regulatory submission documentation
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Aseptic Processing & Environmental Monitoring
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Risk Management Evaluations for medical device components
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Computer system validations & secure audit trails
