Pharmaceutical Services and Methods Overview

Slide Note

In the field of pharmaceutical services, specific elements such as specificity, linearity, range, accuracy, and system suitability play crucial roles. Understanding the complexity of complementary medicine, diverse approaches, and method availability is key to successful testing and validation. Recognition of pharmacopoeias like USP and BP, along with WHO standards, brings a global perspective to method validation. Testing components like active ingredients, stability intervals, and interactions ensures product safety and efficacy. Contact Roy van Brummelen, an experienced professional in pharmaceutical services, for consultations and guidance.

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Uploaded on Mar 04, 2025 | 0 Views

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Roy van Brummelen BPharm, MSc, PhD, DTech Institute for Pharmaceutical Services & Van Brummelen Consultants royvbc@gmail.com

Specificity Linearity and range (standard & sample) Accuracy System suitability Precision Repeatability (co-validation) Limit of detection Limit of quantification Stability of solutions Robustness

Medicine is Medicine (Normal testing guideline) Complexity of Complementary Medicine Diversity in type Diversity in approach Complexity in combinations Availability of methods

Pharmacopoeia (recognized) i.e. USP, BP, etc. Other Pharmacopoeia i.e. WHO, AAMPS (with method validation) Scientific publications (with method validation) What to test ?

CoA? Standardised against? Steps: All ingredients Ingredients clinically active Ingredients for which methods are available Ingredients in measurable quantities (with method validation) 1. 2. 3. 4.