One major benefit that computer systems have on the pharmaceutical industry is that they enable us to keep reliable and up-to-date electronic records which are easier to process, store, and retrieve. Due to the advancement of information technology, management of health records has become very easy. ...

BARBARA PIROLA: Hold time can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications What tools do pharmaceutical ...

Corrective and preventive action (CAPA) noncompliance is one of the top reasons the FDA issues a noncompliance warning. The purpose of a CAPA report in pharmaceutical industry is to document the actions taken to address the issue and prevent it from happening again in the future. This is a systemic ...

The quality of pharmaceuticals is a major concern in the pharmaceutical industry. The quality of the product indicates the seriousness of the manufacturer towards the safety of patients. It means that defects in the quality of the product may harm the user of the product. Low-quality products are not ...

The Quality System covers the following areas of operation: 1 Human Resources – to ensure that staff of appropriate educational level, experience and health are recruited, that their roles and responsibilities are clearly defined and that they are adequately trained, supervised, assessed and their ...

General Instructions = Check the general environment in the department. = Ensure proper gowning by the personnel in concerned work area. = Check for the daily calibration of balance. = Check the calibration status label of machines. = Ensure that the line clearance is obtained before starting the next ...

Objective: To provide a guideline for reprocessing. Scope: This procedure is applicable for reprocessing in tablet department at (Company Name). Responsibility: 1. Production officer shall be responsible for recording the necessary details & to perform the activity as directed. 2. Head of production ...

Objective: To set up a procedures for crimping strength test for all semi-finished products. Scope: This procedure is applicable for semi-finished products manufactured at MDI unit, (Company Name). Responsibility: 1. IPQA Officer shall be responsible for sampling and testing of semi-finished products ...

Objective: This Standard Operating Procedure is to describe that equipment cannot randomly selected and directly put into use. It is essential to ensure suitability for performing Equipment Qualification (s) against requirement and performance capability over a period of use. Hence it is to be qualified ...

a. Quality Assurance Department ensures the quality of all batches produced at every stage of manufacturing/processing of drug products. b. This is achieved by performing monitoring functions in accordance with the prescribed QA system for the following areas: =>> Warehousing of incoming material, containers ...