Manufacturing Site Design and Conceptualization
The manufacturing site conceptualization and designing include the designing of the facility that meets the local and international cGMP requirements as expected by various regulators worldwide. The requirements include and not limited to the layout designing of manufacturing unit, achieving the regulatory expectations of the clean room, Adequate and compliant validation of the Equipment, instruments and utilities and related documentation.
Manufacturing Site Conceptualization Project Services Include Following Stages:
The services include but not limited to the following
Facility Layout & Design
The layout design of the facility is done as per the local and international regulatory expectations. Various aspects are taken under consideration while designing the layout like Storage requirements, Manpower requirements, Sterilisation requirements, Process requirements, Local statutory requirements etc.
Depending on the product requirements, process requirements, Product sterilisation requirements, Product risk classification, We determine the parameters of the clean room as given ISO 14644 and regulatory expectations as per norms. We extend the said requirements to the Cleanroom suppliers for supplying the right systems to achieve the expectations.
Medical Device Process Validation
The Medical Device Process Validation, equipment validation and utility validation shall run through the adequate qualification/Validation life cycle that runs through major stages of the URS, FAT, SAT, DQ, IQ, OQ and PQ as applicable. The adequate validation master plan is prepared and executed. All the validation life cycle is documented through protocol and reports