Important Questions and Answers concerning the Audit Trail Review

The webinar "Audit Trail Review" took place in February 2017. Its aim was to address the main elements of data integrity and audit trail reviews. Participants have sent more than 50 questions regarding the webinar which the speaker, Dr Wolfgang Schumacher, has partly answered in writing. Learn more about the Webinar Audit Trail Review and about the corresponding questions asked.


Warning Letter to Indian API Manufacturer: Equipment Deficiencies

Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. The state of the manufacturing equipment and the missing validation of a tableting process were the main points of criticism. Find out more about the Warning Letter due to equipment deficiencies.


EMA´s Questions and Answers relating to Flexibility in Manufacturing Conditions

The EMA recently published a Questions and Answers document in relation to presentation of process information in the marketing authorization dossier and management of changes to an approved design space. Read more about the document on "Improving the understanding of NORs, PARs, DSp and normal variability of process parameters".


EMA updates Website on Mutual Recognition Agreements

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.


API starting materials - New Q&A document for ICH Q11

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.


EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products

During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.


How to become a QP in Europe

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.


New ICH E9 Addendum reaches Step 2b of the ICH Process

The International Council for Harmonisation (ICH) recently published its proposed E9 Addendum to define the appropriate estimand for a clinical trial. Read more about the draft E9(R1) Addendum: Statistical Principles for Clinical Trials.


QbD: New EMA Guideline on Manufacture of the finished Dosage Form

The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.


Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.


EU-US MRA: New Commitment

There is a new commitment between EC, EMA and FDA allowing to share full inspection reports between agencies.


Test for Subvisible Particles: ICH Harmonisation Completed

With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. Read more about Tests for Subvisible Particles.


FDA publishes Draft Guidance for Medical Gases

Recently, the FDA published a new Guidance for Industry draft document. It is intended to help medical gas manufacturers introduce and implement GMP regulations. Read more about GMP requirements for medical gases.


ICH Q4B - Harmonisation relating to the Sterility Test - General Chapters completed

The International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized.


FDA Final Rule for Antiseptic Soaps

The FDA issued a Q&A document correlated to the final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.


FDA - Bacteriological Analytical Manual, Microbiological Methods for Cosmetics

In July the FDA published the revised version of BAM: Bacteriological Analytical Manual Chapter 23 Microbiological Methods for Cosmetics.


FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms

The FDA is proposing a more restrictive expiration dating for unit-dose repackaged solid oral dosage forms. Read more about FDA´s draft guidance Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.


ECA Validation Group - Update on Activities

The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. Find out more about what is new in the ECA Validation Group.


Brexit: the British comment

After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.


EMA publishes final Version of Q&A Paper on Production of "cold" WFI

After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.


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