Publications and Industry Updates
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Practical HPLC simulator: Software for simulation in liquid chromatography
April 02, 2021
The “Practical HPLC calculator” is a new free simulator using Microsoft Excel® for virtually learning the concepts of high performance liquid chromatography (HPLC) and ultrahigh-pressure liquid chromatography (UHPLC). It has been developed by researchers from the University of Geneva in Switzerland to teach LC concepts using a virtual model calculator. This software is useful for students, professional educators, and trainers to teach and perform virtual HPLC experiments and to accomplish a limited number of real experiments using an HPLC instrument.
Mutual Recognition Agreement: Can Import Testing be completely stopped now?
August, 2019
With the recognition of Slovakia on 11 July 2019, all EU member states are now part of the MRA (Mutual Recognition Agreement).
Can we stop import testing now?
Yes, the provision on batch testing as foreseen in Article 9 of the GMP Sectoral Annex to the MRA came into force on 11 July 2019.
Full answer is attached "Questions & Answers on the impact of Mutual Agreement between the European Union and the United States as of 11 July 2019"
June 2019
"Cannabis Extract, Standardized (Cannabis extractum normatum)" draft for a new German Pharmacopoeia monograph "Cannabis Extract, Standardized (Cannabis extractum normatum)" has been published on May 6, 2019 for comments.
As far as I know this is a first pharmacopoeial monograph for Cannabis Drug Form.
Pay attention, the attached document (the link is a Title) is a Google's translation to English whereas the original is in German, then inaccuracies may exist, e.g. where is written "discontinued" should have been translated "standardized". For the original in German click the below.
FDA and EMEA methods for Testing Nitrosamine Impurities in angiotensin II receptor blocker (ARB)/Sartans
May 2019
Here you can find all methods published by FDA and EMEA for determination of Nitrozoamines in ARBs (Sartans) drug substances and drug products.
Updated on May 2019
December, 2018
Process Analytical Technology (5.25) is included in Ph. Eur.
EDQM says "The adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and scientific state of the art; they will be effective from 1 January 2020 and will be published in 10th Edition of the Ph. Eur."
November, 2018
This isn't uncommon when the sample's diluent in HPLC differs from the mobile phase. Some HPLC users, even in analytical R&D, are unaware or disparage what such cases may result in.
But it does and in very significant troubles: bad peak shape, system peaks, sometimes even worse, e.g. complete disappearance or underestimation of impurities.
Acceptability of Standards from Alternative Compendia (BP/EP/JP) in place of or in addition to the USP/NF
October, 2018
Are the Standards from Alternative Compendia (BP-EP-JP) acceptable on US market? The answer is "Yes" when the standards in the BP, EP, or JP are equivalent to or better than the corresponding USP/NF standards.
Isn't a good way to decrease the product cost and increase the efficiency?
This isn't unusual for global generics to use different procedures for different markets and when they decide to unify them, I come across the cases, not once, when companies perform full validation of Not USP Pharmacopoeial Procedure when they want to submit to FDA and that not because of the consciously taken decision, e.g. they have reasons for such decision, but go the hard way because they are not aware of FDA attitude to that.
Here you can find links to FDA document as well as to Lachamn Consultants' talk about that:
http://www.lachmanconsultants.com/2017/01/usp-bp-ep-jp-which-can-you-cite-in-your-application/
FDA takes next steps to deter "scaring" the Generic Manufacturers by means Citizen Petitions
October, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions.
"One area of focus has been shutting down practices used by branded firms to “game” the system to delay generic approval – thereby extending a drug’s monopoly beyond what Congress intended. One of the most common tactics we’ve taken aim at when branded firms make it hard for generic manufacturers to get access to physical doses of a branded drug...
Another one of these anticompetitive techniques involves the use of citizen petitions."
Laboratory Gaps and lack of proper Cleaning Validation resulted in US Import Alert
August 2018
The Warning Letter issued in May 2018, It includes these main parts:
1. Failure to validate and verify (if the methods are pharmacopoeial) the suitability of analytical methods.
2. Insufficient controls over computerized systems, poor duties segregation, no SOP for second-tier review.
3. Failure to adequately validate written procedures for the cleaning and maintenance of equipment.
"Elemental Impurities in Drug Products". FDA Guidance for Industry
August 2018
FDA has issued the official Guidance "Elemental Impurities in Drug Products".
Earlier document was a draft published in June 2016.
FDA Guidance is fairly short since it follows much more detailed ICH Q3D "Guideline for Elemental Impurities"
Published on May 31, 2018
The article was earlier published on Linkedin. You can find some discussions there.
https://www.linkedin.com/pulse/thoughts-root-causes-data-integrity-problem-michael-pesachovich/
Analytical procedure change can be made with immediate or other post-implementation notification
June 2018
"Analytical procedure change can be made with immediate or other post-implementation notification" if the criteria are in accordance with the recently published for comments ICH Q12 "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management"
How FDA sees scientific justification to invalidate OOS results, using outlier test, electronic data management
June 2018
The attached warning letter is an example of how FDA sees scientific justification to invalidate OOS results, the using outlier test, electronic data management etc.
ICH prepares for future new topics
22 June 2018
ICH prepares for future new topics. The Assembly agreed to begin work on three new topics for ICH harmonisation:
Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14);
Continuous manufacturing (Q13)
Increasing oversight of API manufacturing through international collaboration
April 2018
Interesting summary report has been recently published by EMA (European Medicines Agency): "Increasing oversight of API manufacturing through international collaboration".