GMP News - Quality Assurance

02.06.21

The GMP Requirements for Supplier Qualification

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

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02.06.21

Problems at Emergent BioSolutions Plant even worse

You can't actually believe what you read in the Form 483 that the FDA issued to the Emergent BioSolutions site in Baltimore - the site that suffered a mix-up in the manufacture of a Covid-19 vaccine.

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02.06.21

Unexpected Deviations and the Role of the QP

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations?

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01.06.21

FIFO, FEFO, LIFO: What is the meaning?

FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?

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26.05.21

FDA adopts ICH Q12

The FDA adopted the ICH Q12 Guideline for post-approval change management. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines. It is composed of a Core Guideline and two Annexes with practical examples for ECs and PACMPs.

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26.05.21

FDA updates Q&A Guidance on Inspections and Applications

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and  Drug and Biological Product  Inspections During COVID-19 Public  Health Emergency Questions and Answers Guidance for Industry" with some further clarifications.

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19.05.21

ALCOA+ - what does it mean?

When we talk about data and data integrity, we always talk about ALCOA+. But what is hidden behind this abbreviation and do you really understand the implications?

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19.05.21

ICH E6 GCP Guideline: Updated GMP for IMP Principles

The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs. 

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19.05.21

GMP: Are there "planned" Deviations?

One discussion we have again and again in seminars is the question of planned variations. But such terminology can lead to problems.

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18.05.21

What are the requirements for an eCRF?

What is an eCRF? The MHRA GCP Inspectorate recently informed about the requirements for eCRFs (electronic case report forms). In addition they listed several findings from current GCP inspections.

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12.05.21

MHRA establishes own GMDP Database

The UK MHRA has established a new GMDP database with information issued by the MHRA and from EudraGMDP relating to manufacturing, wholesale authorisations and certificates and non-compliance statements.

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12.05.21

FDA Report on Impact of Pandemic on Inspections

From March 2020 to March 2021, the FDA carried out 821 mission-critical inspections, but only 49 of these were in the area of "Human Drugs". A recent report provides details and an outlook.

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12.05.21

New Version of WHO Guidelines on Process Transfer Published as a Draft

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

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06.05.21

ATMP - Critical Deficiencies during an Inspection in the Netherlands

An inspection by the Dutch authority in February revealed a number of deficiencies at a manufacturer of advanced therapy medicinal products (ATMPs). The Non Compliance Report that was published shows which of these were critical.

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28.04.21

EMA confirms full functionality of CTIS - on track to go live January 2022

Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.

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