One of the most significant sections for industry is chapter 7, “Lifecycle Management and Post-Approval Changes of Analytical Procedures”, which mentions several elements for APLC management, in line ...

The principles of quality by design (QbD) and life cycle management, as outlined in International Council for Harmonisation (ICH) Q8–Q12, can equally be applied to the development, validation, and ...

Michael Dong recently discussed sample preparation (SP) techniques for small-molecule drug substances and solid dosage forms.

AU-C Section 315 addresses a multitude of areas — nearly ... including individuals within the internal audit function (if the function exists), analytical procedures, and observation and inspection.” ...

Analytical chemistry is the science of obtaining ... Quality assurance specialists ensure that laboratories follow documented and approved procedures. Quality control experts ensure the quality of the ...