Bionorm is a GMP certified plant-based API production factory.
What is GMP?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled in accordance with quality standards. Over 100 countries worldwide regard GMP as a recognized standard of high quality.
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 for a GMP system?
Raw material selection: When acquiring suitable raw materials according to our necessity, we make selections based on specific analysis testing methods.
Instrumental analysis (HPLC, GC, UV…)
In process control: During the production process we adhere to strict validation checks to ensure that our products conform to specification.
Validation (Process and Method Validation)
Analytical methods that are used are from the EU Pharmacopoeia jointly with in-house methods.
In 2018, The Turkish Medicines and Medical Devices Agency (TMMDA) was accepted as a full member to the international Pharmaceutical Inspection Cooperation Convention (PIC/s).
Drug Master Files
Drug Master Files (DMF) are 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.