Bionorm is a GMP certified plant- originated API production factory.
What is GMP?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Over 100 countries in the world uses GMP and each GMP may vary according to the country.
Good Manufacturing Practice are systems created and mandated by the government to regulate production, verification and validation of drugs, food and/or medical devices, ensuring that finished products are effective and safe for market distribution.
What are the requirements of GMP system?
Raw material selection: Acquiring the suitable raw material according to our necessity, we go through a selection by specific analysis with different analytical techniques.
Instrumental analysis (HPLC, GC, UV..)
In process control: During the process we do certain checks to ensure that our products conforms to its specifications.
Validation (Process and Method Validation)
The analytical methods that are being used are EU Pharmacopoeia and in-house methods.
In 2013 The Turkish Medicines and Medical Devices Agency (TMMDA) has filed for full
membership in the field of human medicinal products to the inter-agency coordination
body for the Pharmaceutical Inspection Cooperation Convention (PIC/s), of which Turkey became
a member in 2018.
Drug Master Files
Drug Master Files (DMF) is the submission of data to regulatory authorities by means of a document prepared by a pharmaceutical manufacturer to ensure that the production process was appropriate. Bionorm – provides Drug Master Files to our customers in Pharmaceutical Industries.