by Naveen kumar | Jun 6, 2024
The Common technical document has 5 modules and is a format set by ICH for assembling the quality, safety, and efficacy information in a common format. The CTD document was introduced to streamline the dossier submission process as the earlier process was not uniform...
by Naveen kumar | Jun 2, 2024
Guidelines for Tablet Friability Determination as per United States Pharmacopeia Why Friability test is Performed – In this article we are going into detail about the friability test, how it is performed as per guidelines, the number of samples to be taken for...
by Naveen kumar | May 30, 2024
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...
by Naveen kumar | May 28, 2024
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...
by Naveen kumar | May 24, 2024
Standard Operating Procedure for Operation of Rapid Mixer Granulator 1.0 OBJECTIVE: To lay down the procedure for the operation of the Rapid Mixer Granulator in the granulation area of the production department 2.0 SCOPE: This SOP shall be applicable for the operating...
