Tablet coating defects

Like we see defects in tablet compression, tablet coating is also associated with some defects. In this article, we will see the defects that are possible for coated tablets during the manufacturing process and most of the defects are due to the low technical skills...

What is Factory Acceptance Test ?

A product needs to be tested and proven for its quality and compliance requirements before it reaches the factory to the consumer. With the increasing complexity of the equipment being manufactured as per consumer demand, there is a chance for countless errors. So,...

DMF submission Process

Drug Master File Submission Process We have discussed the types of drug master files and their purpose in the previous article now we will learn how a DMF is submitted to the FDA in short. Procedure for DMF submission Electronic Common Technical Document (eCTD): DMFs...

Responsibilities and Roles of Quality Assurance Department

SOP ON ROLES AND RESPONSIBILITIES OF QA DEPARTMENT 1.0 Objective: To outline the roles and responsibilities of the quality assurance department 2.0 Scope: This SOP shall be applicable to Personnel working in quality assurance and activities of QA department. 3.0...

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