FACILITIES DESIGN OR EVALUATION – Isha’s GMP Consultancy

FACILITIES DESIGN OR EVALUATION

Isha’s GMP Consultants is skilled in assisting organizations as they encounter facilities design, construction, or adaptation—or as they encounter facilities-related compliance problems.

Through a powerful blend of compliance, regulatory, scientific, and technical expertise, our consultants are highly effective in:

Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
Developing environmental and processing-room requirements
Recommending effective flow of materials, equipment, and personnel
Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations

Addressing the facilities requirements of laboratory operations
Performing factory acceptance testing of equipment (FAT)
Conducting audits during construction and installation phases
Qualifying facilities for sterile, low-bioburden, and non-sterile products
Qualifying facilities for intermediates, APIs, and finished drug products
Qualifying facilities for medical device components and finished products