What is ICH Q8 Q9 and Q10?

ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. This information can be used to identify the type and focus of studies to be performed prior to and on initial commercial production batches.

What is ICH Q8 guidelines?

This guideline is intended to provide guidance on the contents of Section 3.2. P. 2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH guideline M4).

What is ICH Q10 guideline?

ICH Q10 provides a harmonised model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used together with regional GMP requirements. The regional GMPs do not explicitly address all stages of the product lifecycle (e.g., Development).

What is ICH Q9?

The intention of ICH Q9 is to focus the behaviours of industry and regulatory authorities on the two primary principles of Quality Risk Management, which are: The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and.

What is CPP and Cqa?

A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.

What is q9 guideline?

It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.

Which are the main guidelines of ICH?

The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories.

• Quality Guidelines.
• Safety Guidelines.
• Efficacy Guidelines.
• Multidisciplinary Guidelines.

What is 21 CFR Pharma?

21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals and medical devices. 21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures.