Change Management in Pharmaceutical Industry

Change management in the pharmaceutical industry:  Companies always strive for innovation and continual improvement, and sometimes based on the output of process performance, quality monitoring, and CAPA drive changes in the process or systems. A proper change control...

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...

IN-PROCESS CHECKS DURING COMPRESSION BY IPQA PERSONNEL

In-process checks during compression by QA The IPQA person is responsible for performing the in-process checks at a predetermined frequency along with the production personnel to ensure quality products are consistently produced. As you know pharmaceutical products...

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