SPECTRUM PHARMATECH CONSULTANTS - NEW COMPANY PROFILE

Case Studies
Finished Dosage Forms
SOLID ORALS & INJECTABLE FACILITY (ONCOLOGY)
Shilpa Medicare Ltd. (Raichem LifeSciences), Hyderabad, India
The facility is designed to meet the regulatory requirements of
international bodies such as US FDA, UK MHRA, Australian TGA,
Brazilian ANVISA, PMDA Japan. The entire development comprises of 7
separate blocks spread over 27000 Sq.M. of plot. The structures planned
include Oral Solids block, Injectable Block, R & D Block, Quality Control &
Quality Assurance Block, Administration Block, Canteen, Utility Block,
and other ancillaries like Security cabin, Pump rooms, ETP, etc.
SCOPE OF SERVICES:
Concept Design,
Basic Engineering,
Detailed Engineering,
Containment Strategies,
Procurement Assistance,
Construction Management
SOLID ORAL FACILITY (HORMONES)
Glenmark Generics Ltd., Goa, India
This US FDA approved facility was built on a green-field site and
comprised of two-storey production block along with other ancillary
blocks.
The production block has a pilot plant and a commercial scale
manufacturing section for hormones in Tablet Form. The total built up
area of the is 4830 sq meters which houses pilot plant, commercial
scale manufacturing section, packaging section, warehouse, personnel
gowning areas, technical area for AHUs and routing of services, Quality
control laboratories and administration offices.
The facility was built in a time frame of 10 months. The plant was
designed with a prime emphasis on product, personal & environmental
safety. Layout was prepared to allow unidirectional movement of
material and personnel and minimize potential mix-ups. The main
manufacturing areas were maintained at negative pressure with
respect to peripheral socially clean corridor.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance, Construction Management,
Commissioning & Start Up, Validation Support
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