CategoryGDP

Good Distribution Practice

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...

Getting to the Essence of Data Integrity, APICs Practical Approach

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Data integrity has been an integrated concept since the first GMP’s were published many years ago. Recently we’ve seen many professional/industry organizations and authorities publishing data integrity articles, reports and guidelines. Organizations and governments worldwide feel the need to emphasize the importance of these principles as a result of inspection results.

EU, FDA and WHO Regulations Part Two, FDA Regulatory Requirements and Inspection Tips

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The FDA has always held a special place in our hearts and minds. The “guilty until proven otherwise” approach the FDA is infamous for has become slightly milder over the years, nonetheless we will provide you with some valuable information in this article. It explores why the FDA gained its infamous status and how its inspections are structured, how you can prepare and how the FDA organizes its...

Conducting In-Depth GMP & GDP Audits

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When conducting GMP or GDP audits, you don’t have time to investigate everything in detail, you’ll usually have one or two days for an entire factory, it’s people and its Quality System. Most often you’ll get to glance at a document, a piece of equipment or the types of cleaning agents used in manufacturing. There are, however, times when you will want to investigate something in-depth during GMP...