May 2011

About Author: R. C. PATEL, C. K. BHUVA, MR. R. P. SINGH, MR. ABHISHEK DADHICH, MR. ANIL SHARMA.
Department of Quality Assurance, Gyan Vihar School of pharmacy,
Suresh Gyan Vihar University,
Jaipur, Rajasthan, India-302025

Reference ID: PHARMATUTOR-ART-1053

Abstract
Validation has become one of the pharmaceutical industry’s most recognized and discussed subjects. It is a critical success factor in product approval and ongoing commercialization. This article provide brief introduction about the pharmaceutical process validation and its importance according to regulatory provision, also provide the answer of question like why to do, when to do and how to do it. This work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. 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.

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About Author: Deepali Jaybhaye, Sushilkumar Varma, Amol Gite
Department of Pharmacology, Mahatma Gandhi Mission Hospital,
Aurangabad, Maharashtra – 431001, India.
Vijay Bonde
Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences,
Sewagram, Wardha, Maharashtra – 402102, India.

Reference ID: PHARMATUTOR-ART-1052

Abstract
Tectona Grandis linn. is one of the well known Indian herbs. In Ayurveda Tectona grandis stem extract has tocolytic effect. The main syndrome of preterm birth is caused by uterus contractions from excitatory factors. Administration of tocolytic agents is a strategy to prevent the occurrence of preterm births. The aim of this study was to investigate the effects of Tectona grandis stem extract on the contractions of uterine strips isolated from non?pregnant female Wistar rats (250~350 g) prior injected (Before 24 Hrs) Estradiol benzoate. Contractions of the uterus were induced with Oxytocin 0.01 IU. The results compared with stander drugs like Magnesium Sulfate (75 mg), Nifedipine (0.18 mg), and Isoxsuprine (0.18 mg) along with their effect on frog blood vessels, rat and frog heart, skeletal muscle. After seeing these effects we conclude that Tectona grandis stem extract possess the same tocolytic effect as that of standard drugs.