Quality Control of Pharmaceuticals

  • College of Pharmacy |

Description

(I) Quality control & quality assurance of pharmaceuticals: The course has to be designed for quality control, quality assurance or regulatory affairs personnel who have responsibility for the performance of methods and procedures of different quality control tests used for evaluation of safety and potency of pharmaceutical products. The standard pharmacopeial methods and procedures as well as international guidelines as WHO, EMA, TGA should be discussed (II) Good Analytical Practice and Sampling: Introduction, Sampling of pharmaceuticals and related materials, Type of sampling tools, Sampling plans (III) Documentation (IV) Validation of analytical methods according to ICH Guidelines Q2 R1. Compendial testing, Validation of analytical methods, Data elements required for assay validation (V) Drug stability, stability studies and stability indicating methods Drug stability, Stability testing, forced degradation studies, stability indicating assay methods for drugs according to ICH Q1 R2 Guidelines. Stress conditions for drug degradation according to ICH Q1 R2 Guidelines. Factors affecting drug degradation, Drug expiration, Drug withdrawal from the market. Pharmaceutical regulations according to FDA & EMA (European Medicine Agency) and ISO and BSI. Drug-excipient interactions and adduct formation analytical techniques used to detect drug-excipient compatibility, mechanism of drug-excipient interactions, examples (VI) Official methods of analysis applied to raw materials and end products.

Program

PharmD

Objectives

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Textbook

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Course Content

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