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.

http://www.gmp-compliance.org/enews_4424_IMPs%3A%20%20How%20do%20GDP%20Guidelines%20apply%3F_8397,8527,9008,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

New Drug Approvals

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

http://www.gmp-compliance.org/enews_4397_Draft%20USP%20Chapter%201223%20Validation%20of%20Alternative%20Microbiological%20Methods%20published_8521,8474_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

New Drug Approvals

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.

http://www.gmp-compliance.org/enews_4418_European%20Pharmacopoeia%20Commission%20announces%20Strategy%20for%20Implementation%20of%20ICH%20Q3D_8559,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.

http://www.gmp-compliance.org/enews_4359_Water%20Systems%20in%20FDA%20Warning%20Letters_8398,8427,8428,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

New Drug Approvals

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

New Drug Approvals

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. http://www.gmp-compliance.org/enews_4409_Endotoxin%20Testing%20Recommendations%20for%20Single-Use%20Intraocular%20Ophthalmic%20Devices_8521,9092,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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New Drug Approvals

GMP News: Final ICH M7 Guideline on Genotoxic Impurities published

http://www.gmp-compliance.org/enews_4416_Final%20ICH%20M7%20Guideline%20on%20Genotoxic%20Impurities%20published_8559,8500,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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QbD Case study

Quality by Design (QbD) and the Design of Experiments (DoE):Why, How, Who

http://www.statistics.org.il/wp-content/uploads/2013/04/QbD-and-DoE-Ron-Kenett.pdf

Agenda

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Background

•

Introduction to

QbD

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Why

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Introduction to DoE

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How

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Case studies

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Who

Glenmark Pharmaceuticals to set up a new manufacturing facility in the US

New Drug Approvals

Glenmark Pharmaceuticals to set up a new manufacturing facility in the US

http://timesofindia.indiatimes.com/business/india-business/Glenmark-joins-pharma-companies-setting-up-US-plants/articleshow/38398901.cms

• The facility will be situated in Monroe, North Carolina, USA
• The facility will manufacture oral solids, injectables and topicals over a five year period
Mumbai, India; July 17, 2014: Glenmark Pharmaceuticals Ltd; a research-driven, global, integrated pharmaceutical company plans to set up a new manufacturing facility in the US. The company plans to set up this manufacturing facility at Monroe Corporate Center, North Carolina, USA. The facility will be spread over 100,000 sq. feet (around 15 acre plot) and the company will first begin work on an oral solid unit and thereafter set up manufacturing units for injectables and topicals.

GLEN SALDANHA

CEO GLENMARK

NEW DELHI: Glenmark Pharmaceuticals plans to set up its first manufacturing facility in the US at an estimated investment of over Rs 500 crore to cater to the North American market.

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What GMP 良好作業規範 Changes can we still expect for 2014?

New Drug Approvals

What GMP Changes can we still expect for 2014?

Heraclitus once said: “There is nothing permanent except change”. This statement is even true for the rather conservative GMP environment. What can we still expect for 2014? The answer to that question can be found in a work plan of EMA’s GMP/GDP Inspectors Working Group.

What are the coming plans?

• Finalising the changes planned for the Chapters 3 and 5 of the EU GMP Guide
• Finalising the revision of Chapter 8 of the EU GMP guide (with regard to product shortage notifications and specific risk management concepts)
• Agreeing, in consultation with PIC/S, whether guidance is needed on biofilms concerning Annex 1 of the EU GMP Guide
• Finalising the revision of Annex 15 of the EU GMP Guide (comparison with the new EMA process validation guideline and inclusion of necessary changes in the light of ICH Q 8-10)
• Finalising the revision of…

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Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues

New Drug Approvals

Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues
On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year.

Read more about this Warning Letter here

http://www.gmp-compliance.org/enews_4400_Italian%20API%20Manufacturer%20Receives%20FDA%20Warning%20Letter%20for%20Data%20Integrity%20Issues_8509,S-WKS_n.html

On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. As a result of the inspection and the response of the company to the GMP findings the FDA decided to issue a Warning Letter.

While so far mainly Indian Manufacturers have been blamed by FDA and EU Inspectors for data integrity issues, now also an European API manufacturer has been cited for that problem. According to the Warning Letter the…

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ECA launches the Impurities Forum

New Drug Approvals

The identification and determination of Impurities is a key challenge in pharmaceutical Quality Control. Method Validation, Analytical techniques, Leachables and Extractables are only a few of the problem areas. In addition Elemental (Metal) Impurities and Genotoxic Impurities have caused various uncertainties and questions in industry as well as in authorities. This is why the ECA Academy has set up a comprehensive Impurities Forum with experts from authorities as well as from companies like Boehringer Ingelheim, Novartis Pharma, Baxter, UCB, AstraZeneca, AbbVie and others. To offer a maximum of flexibility the Impurities Forum can be booked for all 3 days or only special parts of interest e.g. on Metal Impurities and/or Genotoxic Impurities. Find out more about the Impurities Forum programme and the options.

http://www.gmp-compliance.org/eca_seminare_isearch_Impurities%20Forum.html

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