Quality control

Quality Control for your high quality products

Polycine Advanced Polypropylene (APP) films and tubes for primary packaging are manufactured in a class C cleanroom A controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out to provide the cleanest area possible. Most cleanrooms are used for manufacturing products such as electronics, pharmaceutical […] environment from medical grade raw materials. The entire production process is monitored and controlled online to ensure the highest product quality.

For the registration of our customers’ products, we have compiled Drug Master files ( DMF Drug Master File
Confidential submission to authorities with manufacturing details, supporting drug's safety and quality. ) for our products.

Polycine products meet physico-chemical requirements of EP European Pharmacopoeia
It is the only guiding document for drug quality testing in Europe. Manufacturers of all medicinal products and medicinal substrates must comply with the quality standards of the European Pharmacopoeia in their marketing and use within […] 3.1.3/3.1.6, DIN EN ISO International Organization for Standardization
International organization for developing global standards ensuring quality and safety in various industries, including pharmaceuticals. 15747, USP United States Pharmacopoeia
It is a technical regulation of the quality standards and verification methods of drugs made by the United States government. It is also the legal basis for the production, use, management and testing of drugs. 661 / USP United States Pharmacopoeia
It is a technical regulation of the quality standards and verification methods of drugs made by the United States government. It is also the legal basis for the production, use, management and testing of drugs. 661.1, and biocompatibility requirements of ISO International Organization for Standardization
International organization for developing global standards ensuring quality and safety in various industries, including pharmaceuticals. 10993, and USP United States Pharmacopoeia
It is a technical regulation of the quality standards and verification methods of drugs made by the United States government. It is also the legal basis for the production, use, management and testing of drugs. Class VI. We have received license approval of China CDE/ NMPA National Medical Products Administration
Same to CFDA, in 2018, CFDA changed its English name to National Medical Products Administration. and have lodged US FDA The Food and Drug Administration (United States)
It is a confidential document submitted to the FDA by the supplier of an active drug substance or packaging material. It includes detailed information about the equipment, process, and materials used in the manufacturing, processing, […] DMF Drug Master File
Confidential submission to authorities with manufacturing details, supporting drug's safety and quality. , Type III packaging material as well as Canada Health Master Files.

Our qualified staff is at your disposal to help with registration matters.