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Pharmaceuticals Industrial revolution
Documentation in pharmaceuticals, good documentation practices in pharmaceuticals, Documentation and Records
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
The objective of this Standard Operating Procedure for Plant Preventive Maintenance is to establish a systematic approach to preventive maintenance for pharmaceutical manufacturing plants. Preventive maintenance aims to ensure the consistent operation, reliability, and regulatory compliance of critical equipment and systems. SOP for Plant Preventive Maintenance TITLE: PLANT PREVENTIVE MAINTENANCE 1.0 OBJECTIVE: … Read more
Pharmaceutical Industry and its product categorization Pharma Industries may be categorized into three parts: Pharma Research and development (R&D) facilities. Active Pharma Ingredient Industries (API). Pharma Formulation Industries. Pharmaceutical Industries & Formulation Facilities General Industrial categorization: Pharma Industries and Formulation Plant structure: To run the pharma facility following are the major departments: Quality Assurance Department … Read more
Validation and Qualifications are the backbones of the pharma industry that has very critical impacts on the finished drug quality. Validation and Qualifications are applicable to every department and have Quality control, Microbiological Controls, Production process validation, Equipment Validation, cleaning validation, Clean room validation, Utility system validations, computer system Validation, and Qualifications. Do you want … Read more
Standard Operating Procedures: SOP (standard operating procedure) is a set of written instructions (step-by-step) developed by a company to help employees when carrying out routine operations. SOPs endeavor for system performance, quality product, and regularity of performance and to reduce confusion and misunderstanding, and noncompliance with regulatory standards. SOPs help to standardize the process, and operation of … Read more