GMP News - Quality Assurance

23.06.21

Will the EU Concept of a Qualified Person spread the World?

PIC/S is planning to adapt EU GMP Annex 16 and has started a consultation/ adoption process.

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23.06.21

EUDAMED - Current Status of the Database for Medical Devices

The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.

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16.06.21

EU-Switzerland: MRA for Medical Devices no longer valid

Due to the new EU Regulation on Medical Devices (2017/745) and failed negotiations between Switzerland and the EU, the corresponding Mutual Recognition Agreement (MRA) will become obsolete. This has far-reaching consequences.

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16.06.21

Ph. Eur. General Notices Chapter - New Structure and Content

The European Pharmacopoeia Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users.

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09.06.21

International Inspections: TGA and the Management of GMP Compliance Signals

The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.

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09.06.21

US Implementation of ICH Q12

The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.

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02.06.21

Copies in the GMP Environment / True Copies

In the context of data integrity, copies and how to deal with them play a central role. How are copies defined, what do the regulations require and what does an inspector expect?

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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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