Newsletter Archiv

2016

    2015

    • (Foreign) Particles in APIs or Excipients – helpful current guidelines 18. October 2015

      Typische GMP-Defizite bei Herstellern von chemischen Wirkstoffen

      The presence of foreign particles (sometimes also referred to as: visible particles, insoluble particles/matter) in APIs or Excipients represents a topic of increasing interest and concern of regulators and customers. Although to some extent technically unavoidable, this is caused by the fact, that analytical methods for the detection have been constantly improved but at the same time the guidance from Pharmacopoeias (e.g. EP, USP) or Continue reading →

    • Excipients: Final EU Guideline for formalized risk assessment ensuring appropriate GMP published 21. May 2015

      Excipients: Final EU Guideline for formalized risk assessment ensuring appropriate GMP published

      After a consultation period of about two years (the respective Draft guidelines have been published in 02/2013), the European Commission has published end of March the respective final EU GMP Excipient guideline (official title: “Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use”). Continue reading →

    • Standards and Guidelines for pharmaceutical Excipients 21. January 2015

      Standards and Guidelines for pharmaceutical Excipients

      The publication of the first American National Standard for pharmaceutical excipients (NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients) just recently underlines again the importance of GMP compliance, not only for APIs and finished drug products, but also for excipients being used in pharmaceutical manufacturing. Continue reading →

    2014

    • Elemental impurities: ICH Q3D has reached step 4 (final guideline) 21. November 2014

      Elemental impurities: ICH Q3D has reached step 4 (final guideline)

      As already pointed out in the GxP Audit News 5/13, elemental impurities (=heavy metals) play a key role in the update of the ICH Q3X series of regulations. ICH Q3D, which is aiming to control the level of metal impurities in medicinal products, has now reached step 4 (final guideline) after step 2b was entered in July 2013. The guideline consists of three parts: Continue reading →

    • “Qualification and Validation” – public consultation on the revision of EU GMP Guidelines for Medicinal Products (EU GMP part I, Annex 15) launched 21. August 2014

      Qualification and Validation – public consultation on the revision of EU GMP Guidelines for Medicinal Products (EU GMP part I, Annex 15) launched

      After discussion in the working groups in 2013, the DRAFT EU GMP guideline “Qualification and Validation” has entered into the next step being adopted as final draft for public consultation. The document reflects changes to other sections of the EU-GMP Guide such as Annex 11, ICH Q8, Q9, Q10, Q11 and changes in manufacturing technology. Besides the traditional approach to qualification and validation also other aspects such as product life cycle, critical process parameters (CPP), critical quality attributes (CQA), design space, continuous process verification etc. are being covered. Continue reading →

    • Active Pharmaceutical Ingredient GMP non-compliances listed in the EUDRA GMP database do not only affect suppliers from Asia 21. August 2014

      Active Pharmaceutical Ingredient GMP non-compliances listed in the EUDRA GMP database do not only affect suppliers from Asia

      The EUDRA GMDP database represents an interesting tool and information source concerning GMP/GDP compliance of global manufacturers. Since most of the APIs are nowadays manufactured in Asian countries such as China and India, often API manufacturers/suppliers from these countries are subject to listings in the “GMP Non-compliance” part of the database. However, as can be seen from the most recent listing, also European API manufacturers are subject to GMP non-compliance findings and subsequent listings in the database. Continue reading →

    • The European Medicines Agency (EMA) published the final version of “The QP declaration template” 21. June 2014

      The European Medicines Agency (EMA) published the final version of The QP declaration template

      After the publication of the draft version (including Questions & Answers document) of the QP declaration template in December 2010 for public consultation (until September 30th 2011), it took quite a while for the EMA to complete the work and to issue the final version, which was published just a few days ago. Continue reading →

    • FDA published Questions and Answers on Guidance document “ANDAs: Stability Testing of Drug Substances and Products” 21. May 2014

      FDA published Questions and Answers on Guidance document ANDAs: Stability Testing of Drug Substances and Products

      Based upon public comments received, the US-FDA has published a 17-pages Questions and Answers (Q&A) document related to the “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers” issued in June 2013. This document, released end of May with an implementation date June 20th, 2014 covers stability testing data recommendations for abbreviated new drug applications (ANDAs).  Continue reading →

    • Revised EU Good manufacturing practice (GMP) Guidelines chapter 6 “Quality Control” published 21. March 2014

      Revised EU Good manufacturing practice (GMP) Guidelines chapter 6 Quality Control published

      Effective October 1st, 2014 the revised EU GMP chapter 6 “Quality Control” was published on March 28th. As reasons for the changes the inclusion of a new section on technical transfer of testing methods and other items such as Out Of Specification (OOS) results are listed. Both items are consequently covered in more detail in the new chapter with the items 6.37 – 6.41 (technical transfer) and 6.7, 6.9 & 6.35 (OOS), respectively. Continue reading →

    2013

    2012

    Among others, blue audits at/for:

    chemistry_umicore-logo
    heraeus-logo
    evonik_industries-logo
    excipact-logo
    hennig-arzneimittel-logo
    diapharm-logo
    lomapharm-logo
    medice-logo
    nabriva-logo
    rpglifesciences-logo
    wdt-logo