European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

FDA 98

FDA Documentation Method Validation Packaging 98

ISPE

MAY 9, 2023

The information results from the authors’ experience working in a global company and managing successful drug registrations in the Latin American region. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., the site where development occurs versus where commercialization is intended).

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. 1 US Food and Drug Administration.

Method Validation 52

Method Validation Documentation Packaging Compounding 52