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 25, 2024
Hold Time Study in Pharmaceutical Manufacturing: We know that the quality, safety, and efficacy of the medicine we produce are paramount. The pharmaceutical industry should develop a system in place to ensure the above such that the products we produce are of quality....
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...
by Naveen kumar | May 24, 2024
Standard Operating Procedure for Cleaning of Fluid Bed Dryer Bag 1.0 OBJECTIVE: To lay down the cleaning procedure for the FBD bag 2.0 SCOPE: This SOP shall be applicable for the FBD Bag in the Granulation area in the Production department. 3.0 RESPONSIBILITY: 3.1...
by Naveen kumar | May 23, 2024
1.0 OBJECTIVE The objective of this Standard Operating Procedure (SOP) is to establish a consistent and controlled process for the procurement, storage, handling, and disposal of biological indicators used for the qualification and monitoring of sterilization...