Biosimilars and Method Validation

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Biosimilars

Method Validation

Hetero Labs Limited-Walk-In Interviews for AR&D/ FR&D/ Analytical DQA On 28th Jan’ 2023

Pharma Pathway

JANUARY 24, 2023

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Hetero also offers custom pharmaceutical services to its partners around the world.

Method Validation

Method Validation Biosimilars Pharmaceutical Companies Pharmaceutical Companies

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

FDA recommends that the following information be made public regarding the PCCP as appropriate: planned modifications, testing methods, validation activities and performance requirements to meet before implementation, and means by which users will be informed of the implementation of the modification.

Documentation

Documentation Labelling Method Validation Communication

Pharmacist Digest

Hetero Labs Limited-Walk-In Interviews for AR&D/ FR&D/ Analytical DQA On 28th Jan’ 2023

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

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