Getz Pharma is a world-class producer of branded generic pharmaceutical products. Getz Pharma produces specialty products at its state-of-the-art formulation plant. These include solid and liquid oral dosage forms (tablets, capsules, syrups, suspensions and dry powder), and injections (sterile liquid vials, sterile liquid ampoules, sterile dry powders and sterile lyophilized powders).
A highly qualified and trained team of scientists, pharmacists, chemists and engineers work in our Research & Development and Operations departments, developing new products in an environment that celebrates continuous improvement in quality.
Our manufacturing site has the latest analytical instruments. We monitor quality assurance through quality systems that ensure the consistent quality of our products.
Our facilities comply with cGMP and WHO standards, and have consistently scored high with the regulatory compliance.
The fact that our products are well-accepted and their demand is growing globally reflects the confidence in their quality by the medical community of doctors and patients.
Our diversified and extensive experience allows us to submit high-quality dossiers and get the application right the first time. As a result, our products are registered in more than 30 countries.
Getz Pharma has an experienced regulatory affairs team in each of the regions where we operate to ensure quick approvals of new products from the respective FDA/Ministry of Health of each country. Our teams are qualified to handle all the scientific disciplines required for the successful registration of new products in different territories.
Good Storage Practices (GSP) at Getz Pharma:
Getz Pharma has a world-class, state-of-the-art, automated, high-rise, temperature-controlled pharmaceutical warehouse. This warehouse meets WHO and U.S. FDA guidelines for Good Storage Practices (GSP). This warehouse optimizes space utilization in a covered area of 800,000 cubic feet and is equipped with two VNA (Very Narrow Aisle) Tri Lateral Stackers with computerized and automated guidance systems that control speed based on the load height and steering angle to travel within the aisles.
The warehouse has temperature monitoring and proper validated logging system with 24-hour, round-the-clock backup generators to ensure the maintenance of the required storage conditions. The facility is also equipped with beam detectors and a water sprinkler system for fire fighting.
Temperature-sensitive products need extra vigilance for maintenance of storage conditions. The U.S. FDA and WHO have stringent specifications for the design and construction of storage space for cold chain products. Catering to this critical aspect, Getz Pharma's warehouse also houses cold storage space for temperature-sensitive products.
Getz Pharma's Cold Storage space is 2624 cubic feet where temperature is maintained at 2° C - 8° C. This Cold Storage facility is equipped with a temperature chart recorder, digital thermometer, backup generator and hooters to ensure the requisite vigilance. Calibrated devices are set on the temperature between 2° C - 8° C and in the unlikely event of the temperature trend goes out of the specified limits, an alarm sets off and sends the signals to the maintenance engineers who are equipped to rectify the system within minutes. This system is operational and functional 24 hours a day, 365 days a year.
|