QA

Why bother amending SOPs (Standard Operating Procedure) at all when things have been fine so far? We worked so hard two years ago during the last amendment, and we already have so much other work, so why stir things up now? On the one hand, it’s just three things that need changing, maybe five sentences …

How to efficiently amend an important SOP to accommodate the interests of all stakeholders, meet requirements, stay sane, and not throw the baby out with the bathwater Read More »

Pharmaceutical wholesalers rely more and more on advanced IT systems for the storage, management and distribution of medicinal products. The introduction of information technology in the pharmaceutical industry has brought many benefits, but at the same time imposes responsibility for ensuring the security, effectiveness and compliance with regulations of these systems.

Pharmaceutical supply chains are inextricably linked to Good Distribution Practices, Good Manufacturing Practices, and the Code of Federal Regulation; these regulations and guidelines ensure that pharmaceutical products are distributed according to appropriate standards and with safety. One of the key elements of ensuring safety and quality in pharmaceutical wholesalers is process validation.

Annex 1, “Manufacture of sterile medicinal products,” is part of EudraLex Volume 4, which provides guidance on the minimum control measures required to protect sterile medicinal products during manufacture. All manufacturers supplying medicinal products to the European market must comply with these requirements to minimize the risk of microbiological, particulate and pyrogenic contamination of the final product.

Medicinal marijuana is a controversial topic. People without awareness often perceive medicinal marijuana as a dangerous, addictive drug used illegally.

The requirements brought in by the Medical Device Regulation have posed a serious challenge for many companies operating in the medical device industry. Adapting to the new legal reality requires a significant amount of time and effort. We have prepared a short guide for the transition process based on the EU recommendations to give you a clearer view of the situation.

Modern IT solutions and industry automation are changing the world, and in many areas are contributing to the dynamic development of various sectors, including the pharmaceutical industry.

The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of?

Medtech companies are facing major compliance challenges.