Convalida del sistema di produzione nell'industria farmaceutica - Convalida del sistema EBR/MES
System validation in the pharmaceutical industry is a crucial process to ensure that computerized systems are fit for their intended use and meet current regulatory requirements. This is a mandatory requirement of cGMP (current Good Manufacturing Practices) and is essential for managing the quality of manufactured products. Any computerized system that could affect Patient Safety, […]
Il sistema di gestione ambientale come catalizzatore dell'eccellenza ESG nella produzione
In today’s world, businesses are increasingly facing pressure to operate in a sustainable and responsible manner. This is not only due to environmental concerns, but also because consumers and investors are increasingly demanding ESG (Environmental, Social, and Governance) performance from the companies they support. Energy Management Systems (EMS) can play a critical role in helping […]
Soluzioni farmaceutiche per la produzione di prodotti farmaceutici. Obbligo di lavorare in conformità alle cGMP.
The pharmaceutical industry is responsible for the development, production, and distribution of medicines and other healthcare products. In order to ensure the safety and efficacy of these products, pharmaceutical companies must comply with strict regulations, including cGMP (Good Manufacturing Practices). cGMP is a set of regulations that outline the requirements for the manufacturing of pharmaceutical […]
Mantenere l'integrità dei dati nella conformità alle cGMP
Data integrity is the linchpin of pharmaceutical manufacturing under Current Good Manufacturing Practices (cGMP). It ensures that data generated throughout the manufacturing process is accurate, reliable, and secure. In this comprehensive guide, we explore the critical role of data integrity in cGMP compliance. We’ll begin by providing a detailed explanation of cGMP, followed by the […]
Come i GMBR (Generic Master Batch Records) possono migliorare l'efficienza del confezionamento
In the pharmaceutical and manufacturing industries, Generic Master Batch Records (GMBRs) are increasingly being used to improve packaging efficiency. GMBRs are a type of master batch record that groups together similar workflows, reducing the number of individual MBRs required. This can lead to significant savings in time and resources, as well as improved compliance and […]
Automotive 4.0: come produrre in modo sostenibile e mantenere i più alti standard qualitativi?
Manufacturers operating in the automotive industry are currently facing a major challenge – maintaining competitiveness while mitigating the environmental impact of production processes requires them to use modern, advanced technological solutions. In the era of Industry 4.0, how can sustainable production and high quality standards be maintained? Key challenges in the automotive sector The automotive […]
Ispezioni di qualità (SPC)
Un software di controllo qualità che esegue verifiche in officina e segnala ogni scostamento in tempo reale, prima che si trasformi in un difetto.
Registro elettronico dei lotti - Automazione ed eliminazione della carta nel settore farmaceutico
It’s no secret that every step of the pharmaceutical manufacturing process must be documented. However, managing paper documentation can be extremely time-consuming for pharmaceutical manufacturers, and human error can be relatively common. For this reason, pharmaceutical companies decided to implement what is known as Electronic Batch Record (EBR) in order to both streamline workflow and […]
Come raccogliere i dati per il rapporto SPC - misure automatiche e manuali?
SPC, or statistical process control, is one of the most interesting tools in the context of quality management. Nowadays, this method is widely used in the industrial sector. During this process, data is gathered for report preparation base on control cards. Meanwhile, by gathering and displaying measurements in real-time, we are able to decrease […]
Come gestire le rilavorazioni nella produzione?
Let’s be honest – the term “rework” is most commonly associated with delays in production. Technically speaking, rework means correcting failed, defective, non-conforming items. It is essential to reduce manufacturing and production rework and repairs in order to save money and achieve higher quality across the board. However, this requires detailed planning and strategies that […]