GMP NEWS 2018

GDP: Are Inspectors looking for Data Integrity?

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

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Fertility Drugs stolen in Italy

More than 16.000 packages of fertility drugs were stolen in Italy when a truck was hijacked.

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IMPs: Applicability of the GDP-Guidelines

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

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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.

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Falsified Medicines Directive - securPharm status report for 2018

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018. Read more about the "securPharm Status report 2018".

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FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

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Manufacturing without process validation and stability testing - the quickest way to receiving a warning letter

If a company neglects basic GMP principles, it is not very likely for it to pass an FDA inspection. Read here, what violations concerning the testing of incoming materials, the final testing of finished products and the control of production processes lead to a warning letter.

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Air technology for laboratories: new VDI guidance published

In April 2018, the new VDI guidance 2051 "Air-conditioning - Laboratories" was published. It covers protection objectives for persons, environment and products in different types of laboratories, such as biological, chemical or radionuclide labs. Read more about the new laboratory guideline.

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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.

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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.

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EMA publishes final Q&A Document on the use of PDE (HBEL) Values

In April 2018, the EMA published the final version of the Q&A document on the use of Health-Based Exposure Limits (HBELs) without special notice. The draft version had become necessary in 2016 because the EMA had generated widespread uncertainty within the pharmaceutical industry with their guideline on setting these limits (PDE values as well). Find out more about the EMA HBEL Document.

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ICMRA recommendations on track & trace implementation

In October 2017, the ICMRA adopted recommendations on the implementation of Track and Trace (T&T) Systems to emphasise the importance of the complexity of these systems. This is relevant for regulatory authorities as well as for the pharmaceutical industry. Find out more about the ICMRA T&T recommendations.

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New USP Chapter on Moisture Barrier of Plastic Packaging Systems

The USP published a draft of a new general chapter on the Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems. Additionally the general chapter Containers—Performance Testing <671> has been revised and published for comment in the same issue of PF.

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Brexit: UK commits to align with EU rules on clinical trials

The UK Government recently confirmed that it is committed to implementing the EU CTR into UK law to the extent possible after Brexit.

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New FDA Guidance on Liposomes

The FDA recently published its final guidance on liposomes. Read more about the authority's guidance for industry on Liposome Drug Products.

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EU Data Protection Regulation - Impact on Clinical Trials & Pharmacovigilance

The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules. Read more about impact of the new EU Data Protection Regulations on clinical trial and pharmacovigilance activities.

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Packaging materials: DIN standard on migration published

Together with project partners from industry and research & development, five associations have agreed on a testing method for evaluation of migration from paper and paperboard. Read more about the migration standard.

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Unexpected deviation: what is the Role of the QP?

The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.

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Insufficient water system design: warning letter in Mexico

Due to severe GMP violations, the US FDA has issued a warning letter after inspecting a Mexican pharmaceutical manufacturer. Major deficiencies have been found in the pharmaceutical water system as well as in microbial laboratory testing.

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How inspectors get trained in QRM

The PIC/S and the US FDA have set up a seminar to show inspectors how to assess Quality Risk Management implementation in industry.

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