What is Q1B?

Q1B means a “qualified institutional buyer” as defined in Rule 144A under the Securities Act of 1933, as amended.

What is ICH Q1A?

Q1A(R2)Stability Testing of New Drug Substances and Products. This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003. This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II.

What is ICH q3 guidelines?

This document provides guidance on the content and qualification of impurities in new drug substances for registration applications. It applies to drug substances produced by chemical syntheses and not previously registered in a region or Member State.

What is ICH stability testing?

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug …

What is photostability chamber?

Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines, Option 2. This unit controls light and temperature conditions through an easy-to-use color touch-screen interface.

How many batches should be consider for photostability testing as per ICH?

Photostability testing should be conducted on at least one primary batch of the drug product if appropriate. The standard conditions for photostability testing are described in ICH Q1B. Data from stability studies should be provided on at least three primary batches of the drug product.

What is ICH Q4 guidelines?

Summary. The ICH Q4 guidelines are generally seen as one of the least successful of the ICH quality initiatives. ICH Q4 is split into Q4A (Pharmacopoeial Harmonization) and Q4B (Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions).

What is ICH q1 guidelines?

Objectives of the Guideline The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.

What is pharma ICH guidelines?

ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.

What is stability zone?

These stability studies zones are created due to the difference in temperature and humidity in different parts of the world. These zones have different ICH stability conditions for pharmaceutical products. Following are ICH stability conditions for these zones.

How is photostability determined?

ACTIVE SUBSTANCE For substances, photostability testing should consist of two parts: forced degradation testing and confirmatory testing. The purpose of forced degradation testing studies is to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation.

What is ICH Q12?

The ICH Q12 Guideline is intended to complement the existing ICH Q8 to Q11 Guidelines and provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle.