Stepwise has a proud knowledge sharing culture
Stepwise is proud to offer a range of free resources with its customers.
We publish free GMP checklists, whitepapers, regulatory updates and also share presentations from the multiple training events we host.
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Articles
Europe Market Analysis
EMA Cannabis Glossary and GACP
ICH Q9 QRM – The guideline on Quality Risk Management
ICH Q9, Quality Risk Management was issued in June 2006. This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products.
Lean Manufacturing
For optimizing your operations in your facility, it is essential that Lean Manufacturing thinking is considered in your facility design.
Typical Pharma Unidirectional Flow Plant Design VS “U” Shaped Plant Design
Often Pharmaceutical Good Manufacturing Practice (GMP) and Lean objectives are counter-intuitive.
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