Digitization and Process Analytical Technology (PAT) without a multimillion budget Why most AI/AI initiatives fail to reach pharma production Executive Summary Digitization and Process Analytical Technology (PAT) offer you a clear competitive advantage by enabling precise control of production in real time. Instead of large batch sizes, you have flexible, small production slots that reduce costs and minimize risks such as quality issues, stock write-offs and complex production planning. Actively use existing machine data and quality controls for process optimization! With simple, customized tools and step-by-step implementations, you can reduce investments, GMP risks and implementation times. In this way, we increase quality, reduce costs and sustainably increase the effectiveness and efficiency of your production, without huge budgets and in small, clear sub-projects.

Part 1: Technology transfer and production transfer in the pharmaceutical industry: success factors and future prospects We examine the crucial role that technology transfer and operations transfer play in the pharmaceutical industry. Transfers in the pharmaceutical industry ensure the innovative strength and competitiveness of companies. We provide insights into the challenges of technology transfer but also give indications of how production transfer is implemented well. The importance of quality assurance and the need to comply with regulatory requirements are emphasized. The blog article highlights the crucial role of technology transfer and production transfer in the pharmaceutical industry to ensure competitiveness and innovation. It provides insights into the challenges and best

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

  Digital transformation of a manufacturing process in the pharmaceutical industry: a guide Background In the dynamic world of the pharmaceutical industry, digital transformation is a decisive 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 customer'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 time required for

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