ICH guideline is Q11 development and manufacture of drug substances (chemical entities and biotechnological / biological entities)
- Published: Thursday December 8 2016 08: 35
This guideline Describes Approaches to Developing and understanding the manufacturing process of the drug substance, and aussi Provides guidance on what information shoulds be Provided in Module 3 of the Common Technical Document (CTD) 3.2.S.2.2 sections - 3.2.S.2.6 ( M4Q ICH). It addresses aspects of development and manufacture That pertain to drug substance, Including the presence of steps designed to Reduce impurities.
- Published: Wednesday December 7 2016 08: 45
The EMA pharmacovigilance system is Described in this manual, qui EMA covers the Organisational Structure, Responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management. This manual Does not cover pharmacovigilance aspects related to veterinary medicines.
- Published: Wednesday November 30 2016 09: 25
Quality metrics are used Throughout The drugs and biologics NDUSTRY to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can be Useful to FDA aussi: to help Develop compliance and inspection policies and practices, Such As risk-based inspection scheduling of drug manufacturers; to Improve the Agency's Ability to predict, and The Therefore, Mitigate Possibly, future drug Shortages; and to encourage the pharmaceutical industry to Implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.
- Published: Wednesday November 30 2016 09: 35
This Quality Metrics Conformance Technical Guide (Guide) reserves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics. Since publication of the Pharmaceutical cGMPs for the 21st Century in 2004, CDER HAS continued to Promote ict vision of "a maximally efficient, agile, flexible manufacturing sector reliably That Produces high-quality drug products without extensive Regulatory oversight."
- Published: Wednesday November 30 2016 09: 15
This guidance Describes FDA's current thinking on Defining, Establishing, and Documenting manufacturing activities of the Parties Involved in contract drug manufacturing subject to current Good Manufacturing Practice (CGMP) requirements. In Particular, we describe how parts Involved in contract drug manufacturing can use quality agreements to delineate Their manufacturing activities to Ensure compliance with CGMP.