Facility

BIO-SCIENTIFIC RESEARCH LABORATORIES (I) PVT.LTD.
Plot No.35/1, RUBY Co-Operative Housing Society, Gorai-2,
Borivali (W), Mumbai-400 091.

Tel: 022-2868 7196, 6500 5290-91.
Telefax: 022-2868 7196.

The facility is of suitable size and constructed to facilitate the proper conduct of bioequivalence studies. The facility is designed to prevent any functions or activity from having an adverse effect on conduct of bioequivalence studies. The location on ground floor has also been chosen for the convenience to conduct the Bioequivalence studies. Besides the clinical pharmacology unit and bioanalytical laboratory, the following special areas have been identified:

		ICU: Well-equipped ICU is designed to manage any emergency situations that may arise during the study.
		Humidity Chamber and Dispensing Area: Access is limited to authorised personnel for dispensing of drug products. An area for storage of the drug products received from the sponsor has been defined. Drug products are maintained at set temperature and relative humidity in a humidity chamber that has controlled access.
		Sample Store: A defined area has been set aside for the storage of clinical samples until their disposal. Authorised personnel for sample storage, retrieval and its disposal, can access the sample store.
		CPU: A defined area has been set for volunteers stay for bioequivalence study consist of 26 beds.

The screening area has been separated from the CPU, so that the activities of screening do not coincide with that in the CPU during the study.

The library facility on the first floor will be utilised for referencing and literature search.

The central store situated in the basement will be used for receiving the inventories and supplies. The short-term storage of the materials will be done in the respective areas of their usage.

The biomedical waste generated in the facility will be disposed off as per the SOP. This waste will be segregated as per the category and kept in the waste segregation area till the transport.

The UPS facility is available for electricity supply in case of power failure.

Site Description

The site is situated at the Gorai, Borivali(W), Mumbai

The areas of the Bioequivalence Center are

Clinical Section consists of the following areas:

		Height / Weight and Volunteer Registration Room
		Sample Collection Room
		Volunteers Staging Area
		Toilet
		Volunteers change room
		Cloak Room
		Doctor Room
		ECG Room
		Clinical Pharmacology Unit (CPU - consist of 26 beds)
		Study Co-ordination Center
		Phlebotomy and Dosing Area
		Sample Storage Room (Clinical Section)
		Humidity Chamber and Dispensing Area
		Clinical Documentation Room
		Volunteer Recreation Room
		Nurse Rest Room
		Intensive Care Unit (ICU)
		Staff Change Room (Clinical)
		Store Room (Clinical)
		Food Dispensing
		Dining Hall
		Waste Segregation Area

Bioanalytical Section consists of the following:

		Staff Change Room
		Sample Storage Room (Bioanalytical Section)
		Sample Processing Laboratory
		HPLC Lab
		LC/MS/MS Lab
		Balance Room
		Washing Area
		Bio Analytical Documentation Room

Pharmacokinetics & Statistics Room

Quality Assurance with Archiving area

The bioavailability and bioequivalence studies are carried at the Bioequivalence center. The studies are guided by the World Medical Association’s, Declaration of Helsinki (Tokyo, 2004).