White Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence.
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Contemporary communications technologies, particularly those relating to the internet, have the potential to revolutionize pharmaceutical manufacturing practices. The judicious use of network communication tools may benefit manufacturing operations in a number of different ways.
This paper begins a discussion on the varied ways to implement packaging validation. Focusing on the primary, secondary and tertiary packaging of drug products, it offers available tools and demonstrates, through limited examples, their use in a packaging validation regime.
In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. This Concept Paper describes issues and risks to consider when establishing a reliable, secure, and economically sound relationship with the SaaS provider. These risks have been divided per relationship stage with some practical process controls offered to mitigate...
This Concept Paper aims to highlight where Data Privacy regulations could apply, and the requirements for system implementation arising from those regulations.
ASTM defines process capability as the natural or inherent behavior of a stable process that is in a state of statistical control, which is achieved when the process exhibits no detectable patterns or trends (ASTM E2281). Statistical tools, such as control charts, are utilized in the determination of process capability, and capability indices are commonly reported. Conceptually, these indices...
The evolution of cloud-based services and solutions in the Life Sciences industry can, in part, be attributed to the focus many leading cloud providers place on security and data integrity. In addition, many leading cloud-based providers are developing teams which are focused on the life sciences industry. These teams include members who understand the regulated nature of the life sciences...
In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. Using a SaaS provider can be an excellent option, but doing appropriate research and establishing the company’s specific needs are critical to making the right decision when having so many choices of providers, models and risks associated with each. This Concept...
This Concept Paper focuses on electronic records and computerized systems – a key area of emphasis for GAMP®. However, manual systems and paper based records remain a key area of data integrity failures. The risks associated with manual systems, including the risks between manual and computerized systems, should not be overlooked. The intent of this Concept Paper is to share implementation...
This Discussion Paper examines some of the topics and challenges related to the implementation of current Good Manufacturing Practice (“cGMP”) Process Validation (PV) lifecycle concepts in the management of Quality Systems for existing (“legacy”) commercial products. The paper aims to identify common issues related to the application of lifecycle principles in a legacy product context, and to...
