The quest for the perfect solution. Never-ending improvement thanks to creativity and the ability to adapt. Always seeing what has been achieved and the current challenges as a starting point and incentive for the next development.
Doing this requires a specific mindset: namely, that of an entrepreneur who always wants to offer his partners the best possible quality. With 100% reliability, no exceptions. Steadfastly convinced of doing the right thing, we at Bachem have lived up to this commitment to quality from the very outset. Embedded as a strategy, established as a company-wide initiative, it shapes our day-to-day activities over the long term.
Our current position as market leader in the production of peptide active ingredients is a result of this consistent focus and, of course, the requirements and appreciation of our customers: Innovation Matters.
Guaranteeing highest quality in products and services
Bachem offers and delivers highest quality products and services to its customers. As part of its business model, the Group supports the development of new medicines and drugs all the way from early-stage inception and development, through their clinical testing and market approval, and finally in their later life cycle as mature or generic products. Bachem ensures absolute quality and safety by comprehensively controlling its manufacturing processes.
Bachem as a public company maintains the goal of being a leading and profitable player in its business. The Company strives to grow continuously and be a reliable supplier by running an innovative, efficient organization. Bachem respects all privacy rules and confidentiality obligations, managed through an information security system.
Product Safety and Quality
Bachem upholds standards to guarantee that products and services fully satisfy customer’s needs and comply with the regulatory requirements. At all sites, processes are in place ensuring that substances produced and delivered comply with the internal, customer and regulatory requirements specified, thereby also guaranteeing that health and safety impacts for employees and customers are reduced to a minimum. Data generated from product nonconformities and customer feedback are analyzed for trends and reviewed for continuous improvement.
Workplace hygiene is a basic requirement for safe handling of active substances, making it an integral element of employee health and safety protection at Bachem. Bachem’s strategy for achieving optimum workplace hygiene consists of three interlinked components: personnel hygiene, a basic hygiene concept and control banding. The approach is based on universal principles of personnel hygiene, such as employee apparel and personal care. In addition, the basic hygiene concept seeks to prevent the release of active substances and their subsequent dispersal by deploying technical and organizational measures, the latter addressing analysis and optimization of personnel and material flows, specifications for cleaning procedures as well as waste disposal. The purpose of control banding is to monitor active substance concentrations in the manufacturing environment and hold them to levels low enough to reliably prevent absorption of an effective dose during work processes.
Efficient Organization, Innovation and Continuous Growth
Bachem strives for processes or tasks to be carried out using the least resources per output. For that means, several Bachem sites started initiatives based on 5S principles or continued and expanded such initiatives to include safety, quality and production. Bachem is a technology-based company that bases its growth largely on innovation and the chemical production of active pharmaceutical ingredients (APIs). Local innovation groups, technology transfer workshops as well as International Chemistry and Technology Meetings (ICTM) lead to a continuous expansion of the Group’s know-how in chemistry and technology and promote growth thanks to creativity, openness, trust and courage.
Delivery Reliability as a Supplier
As a contract manufacturer, outstanding quality of its products and services together with full good manufacturing practice (GMP) compliance is the basis for the Group’s commercial success. Bachem constantly maximizes the number of deliveries made without any error regarding time, place, price, quantity, or quality. This is ensured by targeted investments, well trained and qualified personnel and supported by the quality system in place. The current track record with customers and authorities indicates excellent standing.
Continuous surveillance and improvement is achieved by external & internal audits, the corrective and preventive action (CAPA) system, and regular quality system management reviews. Quality events like batch rejects, customer complaints and deviations are reported on a monthly basis to facilitate senior management oversight. Bachem’s exacting standards to safety and quality prevented any withdrawal of a prescription or over-the-counter (OTC) drug batch from the market in 2020.
In order to handle information responsibly and conforming with laws and guidelines to protect customer privacy as well as Bachem’s intellectual property, the Group enters into Confidential Disclosure Agreements (CDA) with all key customers and vendors. Internal and external confidentiality is secured by a framework of corporate and local regulations. These include the Code of Conduct, the Information Security Management Policy, the IT Security Guideline, and the Information Security User Guideline. Further standard operating procedures (SOPs) and guidelines specify implementation and maintenance of IT infrastructure, hardware, software, and electronic data as well as the handling and storage of paper documentation. Systems are in place to recognize, track and correct deviations and breaches to information security. Furthermore, all employees are trained on the respective regulations at the appropriate level. These efforts have led to the positive result that again no substantiated complaints received concerning breaches of customer privacy were filed in 2020.
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