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...

Concept of Deviation

Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...

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