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The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)
Guideline aims to harminze the approach to the eCTD to create efficiencies for reviewers and decrease the rejection rate for drug applications.
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Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.
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Quality Risk Management
Guideline establishes the environment surrounding risk detection and mitigation in order to maintain high quality pharmaceutical products.
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Pharmaceutical Quality System
Guideline acts as a combination of the previous two guidelines (Q8 and Q9), giving vontext to the concepts. A Pharmaceutical Quality System is explained for practical application across all manufacturing platforms in an effort to maintain quality.
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Points to Consider: ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
Note highlgihts major components of three ICH guidelines (Q8, Q9, Q10), demonstrating their reliance on one another in order to be successfully applied across pharmaceutical manufacturing operations.
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Pharmaceutical Development
Guideline lays the foundation for developing pharmaceutical manufacturing processes, intoducing concepts such as QbD and PAT as key components of a successful pharmaceutical manufacturing operation.
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Good Manufacturing Practice Guide for Active Pharmacetuical Ingredients
Guideline highlgihts important aspects of manufacturing API.
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Electric Common Technical Document
This work establishes the requirements and guidelines for submitting an eCTD to ensure consistency in applications.
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Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.
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Continuous Manufacturing of Drug Substances and Drug Products
Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.
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Analytical Procedure Development
Guideline provides a foundation for consistent development of analytical methods to maintain precision and accuracy, contirubting to the maintenance of quality products.
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Analytical Validation
Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.