PROCESS ANALTICAL TECHNOLOGY Student Name: Vamsi Krishna Vungarala Innopharma Labs: Cohort 12 Level: 8 Date of Submission: 15th April, 2015
Q:1 Discuss why the PAT guidance for industry was identified by the FDA?
A: Traditional pharmaceutical manufacturing is normally accomplished using batch processing, and the samples are collected to check the quality. Unfortunately, the pharmaceutical industry generally has been hesitant to introduce innovative systems into the manufacturing sector for a number of reasons. The most common reason is regulatory uncertainty, which may result from the perception that the existing regulatory systems are rigid and unfavourable to the introduction of innovative systems.
Ex: In pharmaceutical industry, many manufacturing procedures are treated as being frozen and many process changes are managed through…show more content… In general, the determination of blend uniformity involves sampling of the blend using a sample thief and followed by laboratory analysis using chemical methods. In general Magnesium Stearate is a commonly used tablet lubricant that forms a film of low-shear strength around the granule, thereby reducing the friction at the die wall during tablet ejection. Blending for longer durations could result in the incorporation of magnesium stearate intra-granularly, which can influence the bioavailability by decreasing the dissolution rate of the product, due to the hydrophobic nature of magnesium