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.

Follow us on LinkedIn to find out our news feed.

Articles

ICH Q9 QRM – The guideline on Quality Risk Management

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

Lean Manufacturing

For optimizing your operations in your facility, it is essential that Lean Manufacturing thinking is considered in your facility design.

en_USEnglish