GMP NEWS 2019

Safety Features: Handling of Alerts

The safety feature provisions enetered into force - How to report a falsified pack?

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Current Questions and Answers on Data Integrity and Audit Trail Review

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.

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Brexit: OMCL Release Decisions still valid?

What happens if a certificate is issued before the withdrawal date but released after this date? New Q&As give a clear answer.

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EMA starts moving to Amsterdam

The European  Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.

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Hard Brexit: UK amends GMP and GDP Regulations

To face a possible Hard Brexit, UK plans to amend EU GMP Guidance.

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EMA publishes comments on ICH Q12

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.

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Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.

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EMA Guideline on Content, Management and Archiving of the TMF

The EMA published a new guideline on the content, management and archiving of the TMF clinical trial master file (paper and/or electronic).

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When does one speak of a "true" First in Human trial?

A new post, "Is it really a First in Human trial? Categorizing and assessing the risks correctly" has just been published on the MHRA Inspectorate blog.

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Clinical Trials if there is no Brexit Deal

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.

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Non-Compliance at Chinese Heparin Manufacturer

A Non-Compliance Report due to several GMP violations has been issued to a Chinese heparin manufacturer after an inspection conducted by the Italian Health Authority. This report is now available on the EMA website for Non-Compliance Reports.

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Swissmedic Document on the Role of the RP in Contract Manufacturing

The Swiss authority Swissmedic has published a new auxiliary document for the so-called "RP Declaration".

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New WHO Guideline on Testing of Counterfeit Medicines

The World Health Organization (WHO) has published a new guideline describing the procedure for testing supposedly counterfeit or suspect medicines.

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New ISO Standard for Tamper-Evident Packaging

The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".

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News from the ICH on Continuous Manufacturing

In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline ICH Q13.

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Cleaning Validation of Medical Devices: What should it look like? An ASTM Guide provides Answers

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?

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Things to Consider for Medical Device Manufacturers when Relocating

In December 2018, the FDA  published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?

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Foreign FDA Inspections of Medical Device Manufacturers increase by 243% over the last 10 Years

In its "Medical Device Enforcement and Quality Report", the FDA has published current data on its monitoring activities with regard to medical device manufacturers. Find out what's new.

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Hard Brexit: MHRA proposes necessary Arrangements

To face the possibility of a Hard Brexit, the British MHRA has issued an updated guidance proposing some necessary arrangements.

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Cleaning Validation: What can a Quality Risk Management Approach Look Like?

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?

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