Pharmaceutical Technology, Regulatory Sourcebook, March 2022

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

Why critical thinking must be applied before technology to ensure regulatory compliance.

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.

Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.