Flair Pharma The Knowledge Kit.
Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
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
Installation Qualification (IQ) document is a very important document in the VMP (Validation Master Plan) of every pharmaceutical organization. Installation qualification is a documentation process, that will ensure an equipment/machine or instrument has been delivered, installed, and configured at your site in accordance with manufacturer standards and approved with the installation checklist as guided by … Read more
Design Qualification (DQ) is a widely used document in every pharma industry. The DQ is a key input to the commissioning and qualifications as per VMP. After OEM understood the user requirement specification (URS), his team generate the design qualification (DQ) document & submit this to the pharma organization. This also leads to verification that … Read more
URS is the most important document of every pharmaceutical industry which include all information about the particular system or equipment/Machine. URS is the 1st pillar of the VMP Validation Master Plan. URS has all information like Capacity, technology requirements, technical requirements, operational requirements, all types of specifications, etc. In the pharmaceutical formulation plant, the prime … Read more