Production safety: essential for pharmaceutical production and beyond
Last updated: 22 December 2025
Doctors and patients rely on medicines and medical preparations of the highest quality and consistency. Production safety, or its assurance, is therefore an essential component of pharmaceutical production. Production safety includes all technical, organizational, and regulatory measures that ensure a validated, trouble-free, and GMP-compliant manufacturing process. It pursues two essential goals. On the one hand, to keep the product free from contamination and to ensure product quality, for example, by guaranteeing defined active ingredient concentrations. On the other hand, it is also about protecting the production site itself, for instance, from contamination, which ultimately also contributes to product safety.
Production safety in the pharmaceutical industry
In pharmaceutical production, some of the strictest regulatory requirements for product safety apply worldwide. For good reason: contamination and unsafe products pose a significant threat to human lives. Specific requirements arise, for example, from Good Manufacturing Practice (GMP). GMP is an internationally recognized set of regulations, defined by the U.S. Food and Drug Administration (FDA) as binding Current Good Manufacturing Practice (CGMP) and in Europe by the EU-GMP Guide (EudraLex, Volume 4) published by the European Commission, which specifies requirements for the manufacture, quality, and control of pharmaceutical products. This results in specific requirements for what product manufacturing safety means and how it is ensured. For medicines, particular regulations such as GMP and GDP apply. The Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) govern the placing on the market of medical devices and in vitro diagnostic medical devices, respectively. Additionally, there are numerous other international regulations and directives.
Measures for production safety at a glance
When it comes to production and manufacturing safety in pharmaceutical manufacturing, various measures are taken to ensure and validate it. The choice of which one to use depends on numerous factors. The measures and instruments presented here are among the most widely used standard solutions.
- Organizational quality assurance systems such as GMP-compliant documentation, CAPA (Corrective and Preventive Action), and Change Control (systematic management and approval of product changes)
- Validation and qualification of equipment and processes – including cleaning procedures and BFS systems according to Annex 1 EU-GMP
- Redundant systems and in-process controls
- Risk management according to ICH Q9, including FMEA and HACCP analyses
- Personnel training and hygiene concepts according to legal requirements
- Documentation as an integral part of validated processes within the framework of risk management
- Use of modern methods such as sterile filtration and aseptic filling technologies (e.g., BFS systems)
In the pharmacy industry, analytics is an essential component. It ensures that products are present in the correct concentration, are not contaminated, and—depending on the product—are sterile or meet specified, controlled microbiological quality limits (bioburden/microbial limits). Within analytics, the following technologies and methods are used, among others:
- Physicochemical analytics: HPLC, gas chromatography, UV/Vis spectrometry, NMR, mass spectrometry
- Microbiological analytics: sterility tests, bioburden analyses, endotoxin tests (LAL)
- Particle analysis: light scattering, microscopy, dynamic image analysis
- In-process controls (IPC): pH measurement, conductivity measurement, fill volumes, leak tests
Production safety: high relevance in all industries
Production safety also plays a central role in other industries such as the food industry, medical technology, and chemistry – especially in product protection and traceability. In chemistry, for example, there are specific purity levels for chemicals that ensure products can be used for their intended purposes. The highest requirements exist here for high-purity products for micro and ultra-trace analysis.
It is also crucial to respond promptly to errors or uncertainties and to thoroughly understand one's own production process. In general, it can be said that simplifying the apparatus setup reduces susceptibility to errors and that lower complexity makes production lines easier to control. This is a fundamental principle of Blow-Fill-Seal (BFS) technology, whose closed, integrated system minimizes critical interfaces from the outset.