ICH Q10, Pharmaceutical Quality Systems was recommended for adoption to the regulatory bodies of the European Union, Japan and the United States in 2008. EMA then formally approved it that same year. In 2009, the U.S. FDA adopted it as a guidance document. This begs the following question, if companies have adopted the principles of ICH Q10, why have the FDA and EMA been experiencing an increase in the number of data integrity issues found during recent inspections?
With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
Profile Advantage enhances metal detection performance by up to 50 percent in challenging product effect applications. This sensitivity improvement means significantly smaller pieces of metal contamination can be found.
A typical batch fermentation process starts with sterilization so that all micro-organisms found in the mash and reactor are completely destroyed. The mash is heated in the fermenter or a special cooking vessel by injecting live steam or by means of steam coils set in the vessel. Holding the temperature at 121°C (250°F) for 30 minutes is usually adequate to destroy all living organisms in the mash. However some processes require higher temperatures. As shown in Figure 1, a heating/cooling jacket maintains the temperature of the fermentor.
Biopharmaceutical Chromatography Systems are designed for separating and purifying proteins and bio-engineered products. Flow systems are compact in design to maximize throughput. No dead legs in process pipe can exist since unswept areas are more challenging to completely clean as well as delaying product throughput. The systems must maintain a hygienic design. Wetted surface finish must be < 20 μinch Ra and material traceability is important to maintain system integrity.