GMP News - Inspections/Audits


No second chance for a first impression - inspection result by a European supervisory agency

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.



MRA: New Q&As published

The European Medicines Agency (EMA) has published an updated set of questions and answers on the impact of the MRA between the EU and the US addressing questions with GMP relevance.



MRA with FDA: Two new States accepted

Two more EU Member States were evaluated and accepted by the FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.



More Desktop Assessments - less Inspections?

A new PIC/S Guidance can help Competent Authorities (CA) prioritising resources for GMP inspections. It also serves as a model for the pharmaceutical industry for their risk based supplier qualification activities.



New Warning Letter calls for Risk Assessments

In a recent Warning Letter, the U.S. Food and Drug Administration FDA explicitly asks the company to perform risk assessments.



EU: More Inspections and GMP Non-Compliance Statements

The EU GMP inspectorates inspected more drug manufacturing facilities in 2017. Also, according to the European Medicines Agency (EMA) states in their Annual Report 2017 there are more inspections performed now in the EU as well.



Quality Risk Management: What Inspectors are looking for

ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?



Auditing Starting Materials - new APIC Guideline defines Standards

The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.



New EU Template for GMP Non-Compliance Statement

The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.



MRA with FDA: Four new States accepted

Four more EU Member States were evaluated and accepted by FDA and will now benefit from the EU-US Mutual Recognition Agreement for inspections.



GDP Deficiency Data available

The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.



Changes which lead to a GMP Inspection

Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.



Five new Warning Letters - Four Batch Record Review Citations

Data integrity is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots: document and batch record design and review.



Bizarre Warning Letter to Chinese Drug Manufacturer

Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.



Switzerland: important Amendments to the MRA

Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.


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