Introduction to Manual Data Entry to a PI System Manufacturing companies in the life sciences must follow FDA 21 CFR 11 and EU GMP Annex 11 requirements in order to sell products in the US and EU. As many organizations across the industry scale up production from clinical to commercial operations, adequate documentation and access […]

The pharmaceutical industry is one of the world’s most massive, intricate, and beneficial industries today. It creates new developments which might be challenging to track in some cases. Despite this, the impact of these pharmaceutical innovations and manufacturing solutions is immeasurable as they sustain numerous lives. This brings us to discuss the pharmaceutical industry and […]

Process development is the process of creating new and improved production methods. It aims to optimize solutions to meet customer needs, maintain regulatory compliance, reduce costs and improve product quality. Process development in the pharmaceutical industry is a collaborative effort between operators, engineers, technicians, marketers, and production specialists. It involves designing processes, testing different scenarios, […]

As the pharmaceutical industry continues to experience a great wave of growth, it is hard not to mention advanced manufacturing. As a result, advanced manufacturing has become a buzzword often used when discussing the future of factories, including pharmaceutical manufacturing. Combining its various elements aids effective pharma production while it brings flexibility. So stay glued […]

As front liners whose activities play a vital role in supporting patient outcomes, pharmaceutical manufacturers need to get it right the first time. Recreating activities and reproducing products require extra time, cost, and effort and can leave the company prone to quality risks. The concept of Right First Time originates from the implementation of Six […]

The Biggest Trends in Pharmaceutical Manufacturing The pharmaceutical industry has undergone several changes which are often introduced and enforced by regulatory bodies. These changes, which we can also call a revolution, make up Pharma 4.0. Earlier in the day, pharmaceutical operations were manual and required solely the use of paper. However, as technology improved, pharmaceutical […]

Agility in New Areas of Life Sciences and Pharmaceutical Manufacturing Pharmaceutical manufacturing has traditionally relied on centralized facilities for mass pharmaceutical production and distribution. As good as this method is, it may be limited when looking at the larger industry trends. This method guarantees product quality and consistency, but its rigidity prevents new manufacturing methods […]

The Pitfalls of Paper Forms in Pharmaceutical Manufacturing Paper documentation and wet signatures are still all too common in manufacturing operations. At this point, the pitfalls of paper forms outweigh their benefits. This is why many pharmaceutical companies are turning to digital solutions to streamline their processes, reduce paperwork, and make their operations more efficient. […]

Common Compliance Mistakes That Can Get You in Trouble with the FDA Specific laws guide companies in every sector. Compliance with those laws aids effective manufacturing and keeps customers safe, especially in the pharmaceutical and biotechnology industries. Since these industries focus on human health and patient outcomes, adherence to health and safety regulations is crucial. […]

Why Switch to Electronic Room Cleaning? Maintaining a clean manufacturing environment is essential in pharma. The efficacy and compliance of your products and processes relies on accuracy and precision at every step of the manufacturing journey. And that starts with cleaning validation. If clean rooms, surfaces, equipment or packaging is not cleaned thoroughly, entire batches […]