FACILITIES DESIGN OR EVALUATION – Isha’s GMP Consultancy

Isha’s GMP Consultancy

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