cpmp,competent

访客2024-06-24 20:16:5213

CPMP, Competent

1. Introduction

In July 2000, the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) set international standards for clinical research. This article will delve into key points related to CPMP and competency in various pharmaceutical processes.

2. Water Quality Standards for Active Pharmaceutical Ingredient Production

For oral use, the default minimum acceptable standard for water quality in the production of active pharmaceutical ingredients is set at the level of drinking water, as referenced in CPMP/CVMP guidelines. This standard applies unless the active ingredient is classified as a special grade or quality.

3. Guidance on Manufacturing Finished Dosage Forms

In April 1996, CPMP/QWP/486/95 provided guidance on the manufacturing of finished dosage forms. This guidance was issued after discussions in the Quality Working Party and approval by the CPMP in June and September 1995, respectively.

4. Regulatory Standards for Preclinical Safety Evaluation

Various guidelines, such as ICH M3 and CPMP/ICH/286/95, outline the preclinical safety evaluation processes for biotechnology-derived pharmaceuticals. These standards ensure the assessment of potential risks before advancing to clinical trials.

5. Evaluation of Ventricular Repolarisation

CPMP/ICH/302/95 focuses on the non-clinical evaluation of the potential for delayed ventricular repolarisation, specifically addressing concerns related to QT interval prolongation. This evaluation is crucial for assessing cardiac safety.

6. 2001 Adoption by CPMP/CVMP

In November 2001, CPMP/CVMP adopted modifications following discussions in the Quality Working Party and industry representation. These modifications likely enhance existing guidelines or introduce new standards to improve pharmaceutical processes.

7. Filtration Step Considerations

The competent authorities may only consider the use of a specific filtration step acceptable for certain purposes. This highlights the importance of complying with regulatory standards and seeking approval from competent authorities for innovative processes in pharmaceutical manufacturing.

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