Why Stability Testing is So much Important (Climatic Zone & Conditions)? As per STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Q1A(R2)& WHO; The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors …
Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: • Process performance and product quality monitoring …
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MANAGEMENT RESPONSIBILITY & CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (ICH Q10) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Resource Management (a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain …
Most Important Definitions In Clinical Trials. As Per ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE – E6(R1) What is Clinical Trials? What are all terms used in Clinical Trials? How ICH Guideline Define all these terms? ICH has mentioned all clinical study related terms in ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Clinical …
