IMPs: How do GDP Guidelines apply?

New Drug Approvals

Is distribution of Investigational Medicinal Products covered by the new Guidelines on Good Distribution Practice (GDP)? What needs to be considered can be found here.,8527,9008,Z-PDM_n.html

GMP News: IMPs: How do GDP Guidelines apply?

The 2013 Guidelines on Good Distribution Practice (2013/C 343/01) apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines? The Guidelines focus on wholesale distribution of medicinal products. And IMPs are normally not distributed via wholesalers. However IMPs are not particularly excluded. The Guideline may therefore give some guidance on how to supply clinical trial material. Better guidance might be given by the Questions and Answers documents of the European Medicines Agency (EMA). In the part on supplementary requirements, Annex 13, a few Q&As are dealing with storage and transportation of IMPs.

When it comes to transport of IMPs…

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Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

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The USP published the draft of the revised chapter 1223 “Validation of Alternative Microbiologiocal Methods.” Read more.,8474_n.html

GMP News: Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

With the GMP News from 21. November 2012 we informed you about the status of the revision of USP chapter 1223, Validation of Alternative Microbiological Methods. Now the USP published a draft of the document.

The draft provides guidance with regard to the selection and implementation of appropriate methods, i.e. important steps for the evaluation of possible methods, for the selection of the analytical technology and finally for the qualification with regard to a current product. In this context the chapter includes information about demonstration that the new method is comparable to the compendial method, and about applicability as a replacement for an existing method. Furthermore the document provides information about the qualification of a method in the laboratory.

The public…

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European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

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The publication of the final ICH Q3D guideline, which has been announced for September of this year, will lead to extensive revisions to chapters and monographs in the European Pharmacopoeia. Find out in what steps the Pharmacopoeia Commission will proceed.,S-AYL_n.html

GMP News: European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

In a press release from 7 July 2014, the ICH Steering Committee announced that the finalisation of the ICH Q3D Guideline on Elemental Impurities is planned for September 2014. A press release of the European Pharmacopoeia Commission entitled “The European Pharmacopoeia Commission validates its strategy regarding elemental impurities and the implementation plan of the upcoming ICH Q3D guideline” was released 11 days later. In this release, the Commission explains their approach with regard to the integration of the content of ICH Q3D in the European Pharmacopoeia. This is supposed to be done in the following…

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Water Systems in FDA Warning Letters

New Drug Approvals

Among the FDA Warning Letters of the past two years there are every now and then letters citing deficiencies in water systems. On the bottom line the reason for objections is always the same. Read more.,8427,8428,Z-PEM_n.html

GMP News: Water Systems in FDA Warning Letters

Taking a look at FDA Warning Letters from the past two years, objections with regard to pharmaceutical water systems are rather seldom. However, when there are complaints, it is the more interesting that the reason for these complaints is mostly the same: missing reliability. What the authority means in this case is the proof that the water system is capable of securely and reliably producing water in the required quality – taking into account for example the fluctuations in the feed water. The necessary means for this purpose are the validation of the water system and the establishment of a monitoring system which continuously verifies…

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Every fifth FDA Warning Letter includes deficiencies regarding Equipment

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Every fifth FDA Warning Letter includes deficiencies regarding Equipment

The considered period from 2012 until the first quarter of 2014 pertains to both companies in and outside of the United States.

None of the 19 mentioned warning letters is solely due to deficiencies regarding equipment. However, the big picture shows the lack of understanding of FDA requirements relative to used production equipment. In almost every case there are references

to violations against requirements defined in 21 CFR 211.67 (equipment cleaning and maintenance),

such as the absence of a maintenance system or a maintenance system that doesn’t fulfill the requirements.

In one case scratches and rust in production boilers were found. In another case the authority found

obvious defects with regard to the condition of the equipment, and in addition objected to the complete

lack of plans for maintenance and maintenance/cleaning of the production building.

The routine calibration was found to…

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GMP News: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

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Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.,9092,Z-MLM_n.html

Related to several outbreaks of Toxic Anterior Segment Syndrome (TASS) in the past, the U.S. Food and Drug Administration and other government and professional organizations started a collaboration to monitor rare eye condition associated with cataract surgery to help industry develop tools for improving safety of eye surgery medical devices. (see FDA News Release December 2011).

Now the FDA published a Draft Guidance for Industry and for Food and Drug Administration Staff on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Because some of the national outbreaks of TASS have been associated with endotoxin, this guidance document was developed to notify manufacturers of…

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GMP News: Final ICH M7 Guideline on Genotoxic Impurities published,8500,S-QSB_n.html

On on 15 July 2014, the ICH issued the guideline M7 “Assessment and Control of DNA reactive (mutagenic) Impurities in Pharmaceuticals to limit Potential Carcinogenic Risk” as Step 4 document. in In the last step of the ICH process (Step 5) this guideline now has to be implemented in the national regulations in the three ICH regions Europe, United States and Japan. The final M7 Guideline was published exactly 17 months after the release of the draft consensus guideline (Step 2) in February 2013, where it could be commented in a 6-month period.

The guideline comprises information, how impurities in pharmaceutical products relative to their genotoxic potential have to be evaluated with the analysis of structure-activity relationships and how the critical toxicological threshold (threshold of toxicological concern TTC) has to be determined. In the individual chapters…

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