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Now the FDA published a Draft Guidance for Industry and for Food and Drug Administration Staff on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.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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