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Your step-by-step guide — cc countersignature annex
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What active users are saying — cc countersignature annex
Cc countersignature annex
[Music] so I'm delighted that we can present this revised Annex one information session my name is Gordon farkison and I'm one of the initial group who started up the contamination control Network we decided that this was an important subject following the publication initially by the European Commission in August this year 22nd of August and subsequently the pharmaceutical inspection cooperation scheme published their version and the two are identical texts I want to make a comment the green note at the bottom that I'm providing some factual information about the content of this review and then I'm recording and Reporting some industry related feedback and concerns and also my own um personal professional opinions on some of the issues and also on some clarification that I am providing under the banner of the contamination control Network it is early days and the industry is working hard to get its arms around a substantial revision of this regulatory guidance it has moved from 15 odd pages to more than 50 pages and clearly that doesn't happen without a significant change and increase in the guidance included this presentation is going to focus on the clean room and clean Zone related aspects this regulatory guidance includes a great deal in addition to this related to various aspects of sterile products manufacturer including specific guidance related to certain aspects of the manufacturing process now we're not going to have time and no intention within this session to get into every particular so we decided to focus on the clean room contamination control related aspects and I'm delighted to welcome you all to this we've had an amazing response and I hope that this presentation gives you at very least a heads up on major changes and some important aspects that we need to clarify and develop best practice related to [Music] so a deadline there are two deadlines published on the front page of the European version so one year so 25th of August 23 for a majority of the document to be um enforced and two years related to some specific aspects of lyophilizer sterilization and utilization within this presentation I have tried to differentiate specific text from the document which is in blue italics script and then most of the comments and observations are in dark green regular script so why was the document updated well that is actually published very clearly in the forward so it is worth just reflecting on the rationale and justification so there was a joint inspectors working group from the European medicines agency members and the pharmaceutical inspection cooperation scheme and they worked together on this revision now this is the first time that there has been a significant regulatory document of this sort that has actually been written in a Cooperative way historically pics pharmaceutical inspection cooperation scheme has taken on board and endorsed or engrossed the European Union GMP as the Pix GMP with some small modifications it's very very important...
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