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Main aspects of GDP

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he main purpose of GDP is to control the distribution chain and to maintain the quality and integrity of the product. This includes preventing counterfeit medicines from entering the legal supply chain.   There are 3 categories of operational activities for this:  1) Storage control management, such as temperature conditions 2) Distribution control management  3)...

Good Quality Quotes Practices (GQQP)

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ithin the Life Science Industry, Pharma, BioTech and Medical Devices, multiple definitions are used to define the term Quality.  The standard of something as measured against other things of a similar kind The degree or grade of excellence of something An inherent or distinguishing attribute or characteristic possessed by someone or something The totality of features and...

Practical Pointers for Aseptic Facilities (cleanroom qualification)

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When we’re building new facilities clients often ask us; how do I qualify my cleanroom? What are the exact zoning requirements and what specification should my design meet? If you’re facing such questions or if you simply want to benchmark your own qualification against the GMP’s then please download our practical pointers for aseptic facilities document. This document was part...

Contamination control

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One of the important topics in the pharmaceutical and biotech industry or actually in the entire production industry is contamination control.Since our customers are patients, we need to be extra careful and ensure that these vulnerable customers do not have contaminants in their medication. Companies should do their utmost best to keep contamination contained. Which means that a contaminant...

Document revision in PCS intelligence

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hen a company decides to implement an EQMS, it has to make important decisions. One of these decisions is the level of digitalization. Some companies choose to use an EQMS to control printed documents. Other companies choose to only digitalize certain components, while others decide to completely digitalize the entire company. One of the biggest advantages of PCS Intelligence is the level of...

Equipment qualification

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The qualification of equipment is a GMP requirement. Qualification is the documented evidence of the verification that a pharmaceutical machine meets the pre-determined requirements. The definition varies per guideline. For more information you can check the following documents; Annex 15 of Eudralex Volume 4 – LIFE CYCLE APPROACHEMA Process Validation Guideline for Finished Products ...

Validation PCS Intelligence

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One of the first questions we receive when speaking with clients is whether the system is validated or not. Understandably so, because validation is one of the most important aspects of a computer system for the pharmaceutical market. Software that is not validated has no place in a pharmaceutical company.   Validating computer software is an important but labor-intensive task. We at...

GMP OOs – the procedure

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he OOS procedure (out of specification), is always unexpected and obviously, no one likes it. Usually it is a signal that something is not in order somewhere in the entire GMP production/GMP analysis system. In concrete terms, an OOS event also means that if you come across something like this in your organization, there are a few things you need to consider: Solving the actual deviation from the...

The Most important aspect of the gxp’s

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People often ask me what the most important GMP or GDP aspect is. I used to answer these questions with: Risk Management is key and must be incorporated throughout the whole Quality Management System. Or, I would answer that they should never forget to add and implement effectiveness checks within CAPA management. During the years, as a manager, I realized that how good your Quality Management...