06/04/2021 | News release | Distributed by Public on 06/04/2021 07:05
GMP stands for Good Manufacturing Practices. They are the practices required in order to conform to the guidelines recommended by the agencies that control the authorization and licensing of the manufacture and sale of food, beverages, cosmetics, pharmaceutical products, medical devices, and dietary complements, such as the U.S. Food and Drug Administration, or the European Medicines Agency. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.
In the pharmaceutical industry, GMP are very important since patients' lives are at stake. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from utilizing a product which is not effective or even dangerous. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation. But all guidelines follow the same basic principles:
The companies are free to find their way to implement a reliable process for GMP to manufacture their products. GMP standards are not prescriptive instructions. The company's responsibility is to determine the most efficient quality process that meet business and regulatory needs. Thanks to the GMP regulations, medicines are consistent in high quality from batch to batch. Medicines are appropriate for they intended use and meet the requirements of the marketing authorization or clinical trial authorization.
Bachem was established 50 years ago. Already in 1978, the first GMP conform peptides were produced for use in medicine. Since then, we keep expending our locations and number of employees. Our manufacturing facilities in the U.S. and Switzerland comply with GMP standards of regulatory agencies. Our production plants are endowed with state-of-the-art equipment for solvent supply, synthesis, purification and isolation of active ingredients and intermediates. All equipment and containment is GMP qualified and cleaning validated. Overlapping capacities and sizes of different equipment trains facilitate a smooth scale-up in case demand is increasing within the product life cycle. Our GMP sites are located in Switzerland, Bubendorf and Vionnaz, and in the U.S., Torrance and Vista.
To maintain our partners' trust and reputation, we do not stop at the bare minimum. We constantly improve our processes to be the leading CMO in peptides and oligonucleotides manufacturing. Furthermore, we believe that a close working relationship with our clients is the key to our success. This helps to customize and schedule process development packages in order to meet ambitious timelines, to manufacture an excellent quality product, and ensure process efficiency.