Essentica, one of the leading ethyl alcohol manufacturing plants on the Balkan Peninsula, has received the prestigious ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) certificate. This certificate reinforces Essentica's position as a leader in the industry and highlights its commitment to high standards of quality and safety in ethyl alcohol production.
The ICH Q7 GMP for APIs certificate verifies the compliance of manufacturers of active pharmaceutical ingredients (APIs) with the Good Manufacturing Practice (GMP) standards in their production processes. Manufacturers who receive this certificate adhere to strict guidelines and standards for quality and safety in the production of ingredients used in pharmaceutical products.
The primary areas where the ICH Q7 GMP for APIs certificate is applied are:
- Pharmaceutical Industry: APIs are fundamental components used in the production of pharmaceutical products. Certification under ICH Q7 GMP ensures that APIs manufacturers adhere to strict standards of quality and safety, which are essential for the safety and effectiveness of pharmaceuticals.
- Medical Industry: Certified ethyl alcohol is used in the production of medical products such as antiseptics and disinfectants. This product ensures safety and effectiveness in healthcare and medical procedures.
- Laboratory Research: Certified ethyl alcohol is of critical importance in laboratory research, particularly in sample dilution and the preparation of reagents. The stringent standards of ICH Q7 guarantee accurate results and the reliability of research.
- Regulatory Approval: The ICH Q7 GMP for APIs certificate is often required by regulatory authorities such as the Food and Drug Administration (FDA) in the USA and the European Medicines Agency (EMA) in the European Union. This document helps manufacturers obtain approval for their products to bring them to market.
- Quality and Safety: APIs are responsible for the action of drugs and must be manufactured with high quality and safety standards. GMP certification ensures that manufacturers use the correct processes, control ingredients, and adhere to standards of purity and stability for APIs.
- Compliance with International Standards: The ICH Q7 GMP certificate follows international standards and guidelines developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This standard helps harmonize requirements and ensures compliance with international markets.
The ICH Q7 GMP for APIs certification is evidence of Essentica's efforts toward continuous improvement in quality and the highest standards in the ethyl alcohol industry. The company will continue to be a reliable supplier of quality products for the pharmaceutical, medical, and laboratory industries.