OUR MANUFACTURING FACILITY
Zypher’s State of the art production facility in India is designed and constructed to comply with the most stringent requirement of Indian and international regulatory agencies.
Zypher has ability to manufacture a wide range of finished drug products in GMP facilities thus ensuring product quality and packaging to meet with international standards. These facilities are maintained to the highest standard of cleanliness and compliance to quality system and environmental standards. Adequate consideration is given to man and material flow for both, safe working and product handling. Areas are maintained in a manner that the products are manufactured and stored in conditions suitable to maintain quality and efficacy. The design and control of the facilities ensure that the cross contamination and mix-ups are controlled to highest levels. State of the art equipment and instruments have been provided. These machines are GMP compliant, adequately maintained and qualified.
QUALITY CONTROL
Zypher’s State of the art production facility in India is designed and constructed to comply with the most stringent requirement of Indian and international regulatory agencies.
Zypher has ability to manufacture a wide range of finished drug products in GMP facilities thus ensuring product quality and packaging to meet with international standards. These facilities are maintained to the highest standard of cleanliness and compliance to quality system and environmental standards. Adequate consideration is given to man and material flow for both, safe working and product handling. Areas are maintained in a manner that the products are manufactured and stored in conditions suitable to maintain quality and efficacy. The design and control of the facilities ensure that the cross contamination and mix-ups are controlled to highest levels. State of the art equipment and instruments have been provided. These machines are GMP compliant, adequately maintained and qualified.
All products are subjected to extensive stability testing programs to understand the real product behaviour during shelf life. We also monitor in-market product quality through annual product quality review mechanisms.
We believe that all our manufacturing facilities possess adequate effluent treatment processes and minimize any contamination of the surrounding environment or pollution. All these environment protection systems are laid down as per the statutory requirements of applicable laws and environmental policies.
CERTIFICATIONS AND QUALITY ASSURANCE
Zypher Lifesciences has a committed Quality Assurance System lead by Professionals to implement and improve the Quality Management System on a continual basis. This policy is achieved through the well-defined Quality Objectives. The visible results of this stringent adherence to quality assurance processes and practices are that our facilities and products have consistently earned the approvals of global regulatory bodies.
Zypher’s manufacturing facility is approved by the Italian Medicines Agency (AIFA) for its facility in India, MA to manufacture the commercial drug product for customers in the European Union (EU).
AIFA is the government entity responsible for drug regulation and approval in Italy.
This approval was subject to the successful completion of an AIFA audit of Zypher’s manufacturing facility of finished products. affirming the facility's compliance with EU GMP standards.
Apart from AIFA, Zyper’s manufacturing facility also have the approval from Ministry of Health of the Republic of Turkey.