Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
There are Different sources of Contamination in Aseptic Area. An aseptic area is a premise in a clean area, designed, constructed, serviced, and used with the intention of preventing microbial contamination of the product. It is essential to identify the sources from which the contaminants can enter the aseptic area in order to avoid the … Read more
Quality Control in the pharmaceutical industry has a crucial role in the quality slandered of Pharma products. The main goal of quality control is to evaluate and compare product quality to predefined criteria. Quality control is therefore the most important aspect of the pharmaceutical industry. The process of quality control also includes finding any product … Read more
Validation in pharma industrial plants is a process of creating official documentation proving that a procedure, process, or activity used in testing and ultimately manufacturing maintains the appropriate degree of compliance at all times is known as validation in the pharmaceutical industry. In the pharmaceutical sector, it is crucial to guarantee that the process will … Read more
Change Control in pharma industries is the main Quality Management System tool. Every change in the equipments, raw materials, facilities, utilities, designs, formulas, procedures, packaging, labeling, computer systems, and any related paperwork is referred to as a change ( SOPs, quality manual, etc.) “Change control is a formal method by which qualified representatives of appropriate … Read more
Data integrity in the best practices always allows organizations to fully understand their data. Data updates, additions, and deletions must be monitored and audited. The company must ensure that when data is moved from one system to another, or transformed, those transformations are the only thing that happens to the data. Procedures must be put … Read more
Data Integrity in Contamination Control Strategy
Site Acceptance Test SAT is the document widely used document in every pharma industry. The SAT is a key input to the installation and commissioning of equipment as per VMP. After OEM understood the user requirement specification (URS) his team generate the design qualification (DQ) document and factory acceptance test done & submit this to … Read more
Performance Qualification (PQ) is part of the validation master plan in pharmaceutical organizations. This is the method to check the effectiveness, quality, efficiency, and overall performance of the equipment. In a pharma plant, it is necessary that before starting the actual production on the machine it must be qualified through performance qualification protocol and reports … Read more
OQ is the Operational qualification that will perform after the successful completion of Installation Qualification. OQ is the major key step of the Validation Master plan. Through OQ protocol we ensure the actual operation of the equipment/machine. OQ protocol is generally provided by OEM also some organization made their in-house protocols and reports on basis … Read more
The FACTORY ACCEPTANCE TEST (FAT) document is the major document and part of the master validation plan in every pharmaceutical organization. It’s a process that is performed at the OEM factory/Site, a pre-check before the delivery of the machine to the pharma organization site. Below details of are factory acceptance test examples. OBJECTIVE & … Read more