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Technology transfer; production transfer; pharmaceutical industry

Key factors for successful technology transfer in the pharmaceutical industry: Part 1

Part 1: Technology transfer and production transfer in the pharmaceutical industry: success factors and future prospects We shed light on the crucial role played by technology transfer and operational transfer in the pharmaceutical industry. Transfers in the pharmaceutical industry ensure the innovative strength and competitiveness of companies. We offer insights into the challenges of technology transfer, but also provide pointers on how production transfer can be implemented well. We emphasize the importance of quality assurance and the need to comply with regulatory requirements. The blog article highlights the crucial role of technology transfer and production transfer in the pharmaceutical industry to ensure competitiveness and innovation. It offers insights into the challenges and best practices of these processes, emphasizes the importance of quality assurance and the need to comply with regulatory requirements How

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Agile transformation for efficiency and agile processes in validation and qualification

Increased efficiency of administrative processes through optimized qualification and validation

Increasing the efficiency of administrative processes through optimized qualification and validation Background Efficiency in administrative processes is crucial to the success of any organization. In the context of qualification, which comprises the steps IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification), as well as the validation of new systems, it is clear that this process is extremely demanding and involves many departments. This complexity often leads to numerous meetings, long processing times and sluggish decision-making processes. Current status The qualification processes are clearly defined, with several standard operating procedures (SOPs) describing their implementation in detail. Departments such as Quality, Production, Engineering, Finance and Purchasing work closely together. Nevertheless, the decision-making process - especially for risk analyses - is lengthy and labor-intensive. The

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Digital transformation of the pharmaceutical industry

Digital transformation of a manufacturing process in the chemical industry

  Digital Transformation of a Manufacturing Process in the Pharmaceutical Industry: A Guide for Consulting Pharma Background In the dynamic world of the pharmaceutical industry, digital transformation is a key factor in ensuring competitiveness and developing innovative solutions. Especially in the context of Pharma 4.0, it becomes clear how advanced digital solutions can not only increase efficiency but also significantly improve product quality. In this blog article, we highlight a specific use case of digital transformation in the chemical industry that serves as a model for Consulting Pharma. Our client's current situation A complex manufacturing process chain in the chemical industry produces several tons of a product in different variants every day. A key cost factor is the

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Quality by design and technology transfer in a GMP environment

Technology transfer- Quality by Design ("QbD")- GMP

Technology transfer of a tablet manufacturing process: Quality by Design ("QbD") in GMP-compliant consulting for the pharmaceutical industry Background of technology transfer Technology transfer in the pharmaceutical industry, especially in tablet manufacturing, can be challenging. Knowledge about production is often not fully documented, but is based on the experience of individual employees. This leads to relevant knowledge not being taken into account or overlooked when transferring older products. Significant problems can arise at a new location with different production conditions and new employees - as we all know, the devil is in the detail. Current situation at our new customer In our current project, the production process of a tablet manufacturer is to be transferred from one contract manufacturer to another. Unfortunately, an earlier

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