Documented Information Procedures – What You Need To Know Ahead of The Deadline
ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that have not yet upgraded to the revised standard, the ISO 9001:2008 certification expiry date will soon be approaching. Control of...
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Repeat Use Procedure: What Are The Steps To Consider?
In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat Use Procedures. We explain what a Repeat Use Procedure is, the steps to take, and the pitfalls to avoid in...
Case Study: How To Obtain A Certificate of Suitability (CEP)
We worked with a major US manufacturing firm to obtain a CEP. Our team worked closely with the manufacturing company to ensure that the project was completed as efficiently as possible. Recently, the client contacted us to say “Our CEP...
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A New Approach to The Pharmaceutical Quality System
Is your quality system keeping pace with the changes in manufacturing technology and new thinking in how manufacturing companies approach the issues of quality? Many companies have adopted the pharmaceutical quality system outlined in ICH Q10 and experienced the benefits...