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). 

It contains five chapters, namely:

  • General
  • Drug Master File
  • Drug Product Manufacturing and Packaging
  • Amendments to Pending ANDA Application
  • Stability Studies

Reference is made to the ICH stability guidelines Q1A(R2), Q1B, Q1C, Q1D, Q1E. The nonprofit organization, Rx-360 issued a summary of the contents of the Q&As in flash report #469, recently published, as detailed hereunder.

Public consultation started on DRAFT Guideline Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

Beginning of May, the European Medicines Agency (EMA) (prepared by the Biologics Working Party (BWP) and adopted by the Committee for Medicinal Products for Human Use (CHMP)) has started another public consultation for a DRAFT guideline covering process validation requirements for biotech-derived APIs (i.e. recombinant proteins and polypeptides, their derivatives, and products of which they are components e.g. conjugates as defined in ICH Q6B. The guideline may also apply to other biological products such as vaccines or blood products, as appropriate). The public consultation is foreseen to be closed by October 31st, 2014.
The guideline addresses the data requirements for process validation for submission of a marketing authorisation application or a variation. Process Validation can be based on a traditional or enhanced approach to process development. Thereby a company can use either approach to process validation or even a combination of both. Process evaluation and verification studies for the upstream and downstream process are covered in the guideline.

GMP & GDP Auditing of Excipients: blue inspection body provides lectures concerning experiences and best practices at international symposia

Based upon a risk based approach, GMP & GDP auditing of excipient suppliers is required by the EU falsified medicines directive as well as current GMP regulations as a part of the supplier qualification process. Pharmaceutical excipients, including atypical actives, represent however a heterogeneous class of substances which are typically used in many different additional industries as basic chemicals. Auditing of excipient suppliers and distributors can consequently be a challenge for a responsible pharmaceutical professional and different from auditing APIs or finished dosage forms.
Based upon the broad experiences of blue inspection body GmbH in this field, the blue audit professionals will share their knowledge of GMP & GDP auditing, presenting lectures at the following international symposia in Europe and Asia:

Major GxP Events II/2014