GMP NEWS 2016

FDA publishes List of Planned Guidances on Medical Devices for 2016

At the end of 2015, the Center for Devices and Radiological Health (CDRH) published a list containing the guidelines planned for fiscal year 2016 (1st October 2015 - 30 September 2016) as well as older guidelines which might be updated. Learn more about the planned FDA Guidances.

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FDA's Current Publications for Manufacturers of Medical Devices

In irregular intervals, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more about the current publications of the FDA.

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Quality Metrics - Required for Medical Devices too?

Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices.

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FDA´s Emerging Technology Applications Program - Draft Guidance

The FDA recently published a draft guidance for industry on the "Advancement of Emerging Technology Applications". The draft guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC information containing emerging manufacturing (including testing, packaging and labeling, and quality control) technology to FDA. Find out more about the draft guidance for industry "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base".

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Current FDA Warning Letter for Manufacturer Cadila in India

As part of its inspections, the FDA nowadays always examines the integrity of data. This can clearly be seen in the recent Warning Letter from December 2015. Besides, the letter focuses on the inappropriate handling of OOS results. Read more about the current FDA Warning Letter on Data Integrity. 

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Best Practice Guide for Quality Agreements published

The Rx-360 Supplier-Led Working released a Best Practices for Quality Agreements Guide aiming to identify best practices as well as common sense solutions to the quality agreement process.

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Pharmacovigilance: GVP Updates and EMA Newsletter

The European Medicines Agency (EMA) has revised several modules and documents of the Guideline on good pharmacovigilance practices (GVP) and published them for comment, i.e. finalised a document. Read more about the GVP updates.

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Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins open for comments until end of January

The European Medicines Agency (EMA) issued a  draft guideline related to unwanted immune responses against therapetic proteins derived by biotechnological processes. Find out more about this EMA draft guideline.

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FDA Recommendations: Reducing the Risk of HIV Transmission by Blood and Blood Products

The FDA adopted and published the Guidance for Industry "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". Read more about these FDA recommendations.

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FDA publishes Guideline on Good Meeting Management Practice for Biosimilar Development

In November, the FDA published a Guideline on formal requesting, planning and performing meetings with the Agency with regard to the development and submission of biosimilars. Find out more about the FDA Guideline on Good Meeting Management Practice.

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FDA publishes two Draft IND Guidances for Comments

Two FDA draft guidances regarding INDs have been published for comments in December 2015: "Best Practices for Communication Between IND Sponsors and FDA During Drug Development" and "Safety Assessment for IND Safety Reporting". Find out more about the draft guidances on investigational new drug applications (INDs).

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Further Regulations within the CEP Procedure: Changes in Contact Persons and Complaints Procedure

Two documents of the EDQM regulate matters which haven't been covered by "public documents" so far. Read more about what has to be considered by applicants or holders of a CEP in case of personnel changes or complaints during a CEP procedure.

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New FDA Guideline on Certification of Medical Gases

The FDA has recently published a new Guideline as a draft which describes the certification process of medical gases i.e. gases for direct administration to human beings or animals. Read more about the FDA Medical Gases Certification Guideline.

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Revised USP Chapter <670> Containers - Auxiliary Packaging Components

In the Pharmacopoeial Forum 42(1) a revised Draft of USP Chapter <670> Auxiliary Packaging Components was published for comments. Comment deadline is March 31, 2016. Read more about the revised USP Auxiliary Packaging Components Chapter <670>.

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MHRA Pharmacovigilance Inspection Metrics Report Published

The MHRA GPvP inspectorate published their latest inspection metrics report for the period of April 2014 to March 2015. Read more about the findings identified during all 48 inspections conducted during this period.

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FDA gives Advice on the Use of Control Charts

In a previous News from October 2015, we pointed out that the FDA has been observing more and more deficiencies in the area of statistics with regard to process validation. One of the "statistical methods" - also stated in FDA's Process Validation Guideline - is the use of control charts in the context of a statistical process control (SPC). Learn more about the views of an FDA representative on the use of control charts.

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