The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment i... Read more
Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-p... Read more
The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense. Subpart Subpart Section of CGMPs Qualification and control docu... Read more
Statistical process control (SPC), also called statistical quality control and process validation (PV) SPC comprises the various mathematical tools (histogram, scatter diagram run chart, and... Read more
OBJECTIVE To design, engineer, and supply the Blister Packing Machine (Model: BQS) and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the... Read more
OBJECTIVE AND SCOPE To design the equipment / instrument in conjunction with the design data in order to provide basis for vendor, manufacturer & / or the design engineer for designing t... Read more
Operational qualification for WFI generation plant
OBJECTIVE To establish documentary evidence to demonstrate the WS system is qualified for correct operation as per guidelines outlined in this protocol & operational manual SCOPE OF THIS... Read more
OBJECTIVE To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as per the URS and it complies wit... Read more
PURPOSE: To describe the Installation Qualification of Medicament Preparation Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meet... Read more
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