Manav Bharti University

Pharmaceutical Process Validation: A CGMP Concept

About Authors:
Satinder Kumar
Manav Bharti University,
Solan (H.P)

Validation is the most recognized and important parameter of GMPs. This article provide introduction about the process validation of pharmaceutical manufacturing process and its importance according to The U.S. Food and Drug Administration (FDA). This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process. Quality cannot be ensured by sampling, testing, release of materials and products. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation of a process will ensure production of drug of reproducible quality. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Stomach Specific Mucoadhesive-A Review

About Authors:
Shalini Sharma, Manoj Prashar
Manav Bharti University,

Stomach specific mucoadhesive drug delivery system(MADDS) is one of the most prominent and latest system which sustain drug blood concentration and controlling the rate of drug delivery to the target tissue. These systems interact with mucin molecule and mucous layer covering the mucosal epithelial surface and prolong the residence time of the dosage form at the site of application or absorption and thus contribute to improve or better therapeutic performance of drug. This review article also present the polymer used for preparation of mucoadhesive tablet, mechanism of mucoadhesion, factor affecting mucoadhesion and recent developments or techniques in formulation of mucoadhesive tablet and invitro and invivo evaluation of mucoadhesive tablets.