GMP NEWS 2021

New WHO Draft on GMP for IMPs

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GMP for IMPs.

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EMA Drafts on Quality Requirements for IMPs

The EMA has published two draft guidelines on the quality requirements for IMPs (small and large molecules). According to the Agency, the documents are to be seen in connection with the Clinical Trials Regulation (EU) No. 536/2014 which is expected to become applicable in January 2022.

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New WHO Draft on GxP for Development

Last year the WHO published draft documents on "Good manufacturing practices for investigational products" and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. Read more about WHO´s revised guideline on GxP for Development.

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Risk Assessment for On-Site Inspections

PIC/S has developed an FMEA-based risk assessment for routine on-site inspections (Covid-19 Risk Assessment for National Routine On-Site Inspections).

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Revision of USP <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples

In the Pharmacopeial Forum, PF 47(4), a proposal of USP Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples has been published for comments.

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Protective Properties of Colored Glass Containers

USP´s General Chapters–Packaging and Distribution Expert Committee (GCPD EC) proposes to replace spectral transmission with spectral absorbance for amber glass containers based upon wall thickness.

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FDA Warning Letter: Missing Stability Data of the API

In May 2021, the U.S. FDA issued a Warning Letter to an Indian OTC manufacturer due to significant violations of cGMP regulations for drug products.

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CJEU Judgement on OTC Medicines

In a recently published ruling, the Court of Justice of the European Union (CJEU) decided that a medicinal product not subject to medical prescription in one Member State may not automatically be placed on the market in another Member State. Rather, the medicinal product may only be placed on the market in a Member State if the competent authority of that Member State or the EU Commission has granted its marketing authorisation.

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Acting as a Responsible Person (import) (RPi): MHRA concretises Eligibility Criteria

Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance called "Acting as a Responsible Person (import) ". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi. This guidance was now updated, listing extensive qualification requirements for RPi's.

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European GDP Association nominates Alfred Hunt as new Advisory Board Member and Deputy Chair

The European GDP Association, representing about 3.500 professionals from across the globe, has extended its Board. Alfred Hunt was invited to join the Advisory Board and accepted to take over the role as a Deputy Chair.

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Revision of USP <857> Ultraviolet-Visible Spectroscopy and <1857> Ultraviolet-Visible Spectroscopy - Theory and Practice

In the Pharmacopeial Forum, PF 47(4), proposals of USP Chapters <857> Ultraviolet-Visible Spectroscopy and <1857> Ultraviolet-Visible Spectroscopy—Theory and Practice have been published for comments.

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10th Edition of The International Pharmacopoeia

The 10th Edition of The International Pharmacopoeia is now available online. It contains recommended procedures for analysis and specifications for APIs and dosage forms.

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The End for the Rabbit Test - only Alternative Methods in 5 Years

Following its 170th meeting the Commission of the European Pharmacopoeia announced that after a defined transition period the pyrogen rabbit test will be completely replaced.

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Updated Templates for Reporting Nitrosamine Contamination to Regulatory Authorities

Marketing authorisation holders in Europe must evaluate their chemically synthesised or biological medicinal products with regard to nitrosamine impurities and, if necessary, carry out confirmatory testing. Detection of nitrosamines has to be reported. Read more here about which templates must be used for reporting nitrosamine impurities.

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EDQM's Experience with Real-Time GMP Remote Inspections

"Innovation overcoming adversity". This is the title of a publication by the European Directorate for the Quality of Medicines & HealthCare (EDQM) on the topic of "Real-Time Remote Inspections" (RTEMIS).

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Q&A Document on Nitrosamine Impurities Updated

The latest revision of the EMA's question and answer document on nitrosamine impurities in medicinal products includes clarifications of some important issues. Read more here about the requirements for reporting nitrosamine impurities to regulatory authorities and the current deadlines for this.

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BfArM starts Sale of medical Cannabis "Made in Germany"

Finally it´s done: The BfArM has started the state sale of medical cannabis from German cultivation. However, importation remains possible.

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PIC/S publishes final Document on Data Integrity

The Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the international association of pharmaceutical inspectors, published the long-awaited guidance document on data integrity on July 1, 2021. Read more about the contents of the document PI 041 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

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Brexit: EU defines possible Solutions for Northern Ireland

The European Commission tries to find "creative solutions" for issues related to the implementation of the Protocol on Ireland and Northern Ireland.

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EMA publishes Q&A Document about Parallel Distribution

Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder. In this context, the European Medicines Agency (EMA) has recently published a new comprehensive Q&A document containing answers to the most common questions.

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