www.americanpharmaceuticalreview.com ONLINE FEATURES Reaching the Next Level with EXCiPACT™ Certification


An Interview with Frithjof Holtz, Head of MM-QS Advocacy Merck Millipore Quality and Regulatory Management Darmstadt, Germany


Tell us about when and how EMD Millipore decided to undergo the EXCiPACT™ audit? EMD Millipore is very active in the field of APIs and excipients and has been a member of several industry associations for many years (such as IPEC Americas, IPEC Europe, European Fine Chemicals Group EFCG, and others). These associations together with others developed EXCiPACT™ as a program to ensure excipients are manufactured according to best practices. There are no legally binding regulations in Europe or the US on GMP for excipients but there are voluntary standards. The idea was to create something where the supplier can really prove that excipients are manufactured according to best practices. EXCiPACT™ is a further development of the IPEC/PQG Guideline on Good Manufacturing Practices for pharmaceutical excipients and the IPEC Guideline on Good Distribution Practices for pharmaceutical excipients, combined with a very high quality certification scheme. Therefore, it was a logical step to participate in the pilot phase of the EXCiPACT™ certification program in order to reach the next level.


With the certification scheme, we have recognized standards for suppliers and users and we also have a tool that combines evidence of compliance, mitigating the burden of customer audits. The excipient supplier can now prove implication of GMP and provide customers with an EXCiPACT™ certificate plus the audit report. Ultimately this saves time and money for both sides.


To read more visit: http://goo.gl/b81ZXi


Review Recap: Te Bioprocessing Summit


Where: Boston, MA When: August 2013


This year’s Bioprocessing Summit offered a suite of fruitful sessions covering early IND strategies, single-use technologies, biomanufacturing, cell culture, cell line development, and more. Meetings with exhibitors and first-hand accounts of sessions will offer information on highlights from this popular industry event.


For a synopsis of The Bioprocessing Summit, visit: http://goo.gl/hUJjys


What’s Lurking in Your Environment? Our Instantaneous Microbial Detection™


Solutions Can Help Shed Light.


• Immediate results


• Displays particle size and biologic status from 0.5μm to >10μm


Our IMD-A® systems monitor controlled areas in real time, detecting


microbes instantaneously so you can act. Our systems utilize advanced optics and signal processing, requiring no staining, no reagents, and little human intervention. Let us help shed light on what may be lurking in your environment.


• No staining or reagents needed • USP <1223> compliant • EP 5.1.6 compliant • 21 CFR Part 11 compliant • Networked solutions


www.americanpharmaceuticalreview.com |


| 109


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133  |  Page 134  |  Page 135  |  Page 136  |  Page 137  |  Page 138  |  Page 139  |  Page 140  |  Page 141  |  Page 142  |  Page 143  |  Page 144  |  Page 145  |  Page 146  |  Page 147  |  Page 148  |  Page 149  |  Page 150  |  Page 151  |  Page 152  |  Page 153  |  Page 154  |  Page 155  |  Page 156