Nature of Construction and Finishes:

The factory buildings where warehouse, manufacturing and testing facilities are constructed with reinforced concrete cement. The warehouses are separated from the production areas. Separate area is available for storage and handling of solvents and packaging materials.

Storage facilities provided for the following hazardous chemicals:
• Gaseous materials in cylinders are stored in isolated areas.
• All the raw materials are stored in appropriated designated areas.
• Production building are constructed with RCC and with suitable sheet roofing.
• Production blocks are well separated from each other, first floor of total blocks are provided with cement board sheet roofing.
• The pharma area for API is constructed on the false ceiling concept where roofing is false ceiling structure with 8 feet height and it meets ISO Class -8 clean area requirements.
• The pharma areas for API are constructed with applicable GMP requirements to minimize the product exposure or contamination.
• Air handling systems are provided to supply filtered air in the pharma area with single pass flow.
• Quality control facility is well established with all set-up equipment’s/instruments are in place for sampling and testing of incoming raw materials, packing materials, intermediates and finished products.
• Released for use or for further processing is formally assessed through the results of inspection.

The external laboratories are qualified as per internal standard operating procedures and samples are sent as per specific customer requirements or any internal requirements with well established test procedures and specifications. The suitably trained / qualified analysts can test the materials against predetermined specifications and test procedures. Analytical raw data can be recorded in relevant books. Adequate documentation of procedures is in place applicable to the APIs supplied to the market and the intermediates. Sufficient retention samples of saleable intermediates or APIs are retained to permit future examination.

Broadly quality control activities are as follows:
• All the documents related to the quality control systems are available and followed routinely.
• Testing of raw materials, packing materials, intermediates and APIs.
• Conducting of stability studies.
• Controlling of retention samples.
• Issuance of certificate of analysis for the release products.
• Involving in customer complaints investigation.
• Working / reference standards are qualified and records are maintained.

Brief description of air ventilation systems: The air handling systems are designed to maintain ISO class 8 area in the API pharma room. Qualification of AHU system and periodical monitoring of the system is carried out periodically by external agency. AHU is facilitating for each pharma line to intend for API powder processing operations. AHU is designed to supply filtered air in pharma rooms with single pass air and about 20 air exchanges per hour.

Brief description of the water systems including sanitation: Vaasavaa has a facility of water system to generate Purified water. This water is used for the manufacturing of APIs for both processing and cleaning of the equipment. The Feed water drawn from MIDC and stored in the raw water storage tank in 20KLcapacity and tested on daily basis for Description, pH & Hardness as per defined in-house specification and test methods. The feed water is passed through sand filter, carbon filter, cation unit, anion unit and mixed bed followed by polisher and this water called as a purified water.

Quality management system: The manufacturing activities in the facility is carried out as per ICH guidelines and schedule-requirement prescribed by Drug control authority of India. The current good manufacturing practices are followed in the day-to-day activities in the facility. The directions to perform various activities are described in the Standard operating procedures and management systems are followed to meet and achieve the quality policy of the organization. The quality policy of the organization is given below.

Quality Policy: We, at Vaasavaa Pharmaceuticals (P) Limited are committed to achieve excellence in quality standards by adhering to the regulatory and statutory guidelines and supply quality APIs and intermediates as per the customer requirements. We shall strive to become globally respected partner through technical capabilities and including high degree of customer satisfaction.