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Facilities Design & Evaluation
Facilities Design & Evaluation
At Isha’s GMP Consultancy, we specialize in facility design, evaluation, and compliance solutions for the pharmaceutical, biotechnology, and healthcare industries. Whether you are setting up a new facility, upgrading an existing plant, or addressing compliance concerns, we provide expert guidance tailored to your needs.
Our Expertise Includes:
- Engineering Design & Compliance Solutions
- Analyzing, developing, and enhancing engineering requirements, specifications, and drawings
- Expertise in HVAC, water systems, sterilization, and dust-control technologies
- Designing environmental and processing-room requirements to meet regulatory standards
- Manufacturing & Operational Flow Optimization
- Recommending optimized flow of materials, equipment, and personnel
- Assessing & improving facility design for manufacturing, assembly, packaging, labeling, and distribution operations
- Laboratory & Equipment Validation
- Addressing laboratory operation requirements for compliance
- Factory Acceptance Testing (FAT) for equipment validation
- Auditing during construction and installation to ensure regulatory adherence
- Facility Qualification & Certification
- Qualifying facilities for sterile, low-bioburden, and non-sterile products
- Facility qualification for intermediates, APIs, and finished drug products
- Validation of facilities for medical device components and finished products
With Isha’s GMP Consultancy, you can be assured of best-in-class facility design, evaluation, and compliance support to meet global regulatory standards and optimize operational efficiency.