All Categories (1-12 of 12)

1. The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)

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   09 Jun 2023

   Guideline aims to harminze the approach to the eCTD to create efficiencies for reviewers and decrease the rejection rate for drug applications.

2. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

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   09 Jun 2023

   Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.

3. Quality Risk Management

   0.0 out of 5 stars 

   09 Jun 2023

   Guideline establishes the environment surrounding risk detection and mitigation in order to maintain high quality pharmaceutical products.

4. Pharmaceutical Quality System

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   09 Jun 2023

   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.

5. Points to Consider: ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation

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   09 Jun 2023

   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.

6. Pharmaceutical Development

   0.0 out of 5 stars 

   09 Jun 2023

   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.

7. Good Manufacturing Practice Guide for Active Pharmacetuical Ingredients

   0.0 out of 5 stars 

   09 Jun 2023

   Guideline highlgihts important aspects of manufacturing API.

8. Electric Common Technical Document

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   09 Jun 2023

   This work establishes the requirements and guidelines for submitting an eCTD to ensure consistency in applications.

9. Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

   0.0 out of 5 stars 

   09 Jun 2023

   Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.

10. Continuous Manufacturing of Drug Substances and Drug Products

    0.0 out of 5 stars 

    09 Jun 2023

    Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.

11. Analytical Procedure Development

    0.0 out of 5 stars 

    09 Jun 2023

    Guideline provides a foundation for consistent development of analytical methods to maintain precision and accuracy, contirubting to the maintenance of quality products.

12. Analytical Validation

    0.0 out of 5 stars 

    09 Jun 2023

    Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.