» Project Management
The very first requirement for GMP compliance is the building and facilities design that plays very important role for the GMP and Regulatory compliance.
To carefully review the basic concept and the design of a plant based on general documents such as layout drawings, Master Plans, facility description, URS, etc, and/or on-site checks and to provide comments and details that helps – if necessary – to modify the design of the plant to finally comply with the relevant GMP requirements.
We undertake following projects :
- GLP Compliant Chemical Testing Laboratories Layout design
- GLP Compliant Chemical Testing Laboratories Setup
- GLP Compliant Biological/ Microbiological Testing Laboratories
- GMP compliant Manufacturing facility design input
- Regulatory Input in the upcoming manufacturing facilities
- Technical Discussions for the existing and upcoming facilities
- Types, intended uses and no. of products to be produced in the plant should be decided.
- First design of plant, premises and rooms should be in place (conceptual or basic design).
- Basic engineering documentation (e.g. actual P&IDs, layout drawings, equipment lists) should be in place.
- URS based on a detailed risk assessment should be available