FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

Documentation

European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

Documentation

GMPSOP

JUNE 9, 2024

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Proper labeling and traceability are essential when it comes to reagents.

Method Validation

Express Pharma

MAY 22, 2023

As the experts at this round table also discussed the need for such a centralised body, Srivastava, who was part of a meeting held by the Nutraceutical Task Force, informed that the formation of a nutraceutical panel in the Ministry of Commerce to ensure a nutraceutical industry-specific agenda is underway.

Dosage

GMPSOP

MAY 31, 2024

A validation master plan provides a holistic view of all validation activities your site should engage in for a set period (e.g., The VMP should provide information on: – Which items are subject to validation or qualification? – Schedules of validation. Method validation master plan?

Documentation

GMPSOP

APRIL 3, 2023

There are also forms, logs, and registers to keep track of all the little details, as well as product specifications, analytical methods, manufacturing formulae, calculation of raw data and more. Sometime these are labelled as the “hidden factory”. One of the widely used protocols in the laboratory is method validation protocol.

Documentation

GMPSOP

OCTOBER 28, 2023

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.

Documentation