GMP NEWS 2019

GDP-Inspector: Why Supplier Qualification is important

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

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New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site. 

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New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.

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Recent GMP defects in process validation

What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.

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Fundamental GMP defects at manufacturer of homeopathic drugs

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs for human and veterinary use.

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Warning Letter on Data Integrity Issues in the Microbiological Laboratory

Among other things, insufficient or missing reports of test results in a microbiological laboratory resulted in a Warning Letter addressed to the company concerned. Read more about the Warning Letter to Hospira Healthcare India Pvt.

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How does the GDPR impact Clinical Trials?

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

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Numerous GMP Deviations found at US Manufacturing Site

Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.

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MRA EU - FDA has approved two more countries

With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved.

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Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

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Ensuring the data integrity of cloud service providers

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?

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BfArM awards first contracts for Cannabis

The BfArM has awarded the first contracts for the cultivation of medicinal Cannabis in Germany to two manufacturers. This means that the cultivation of pharmaceutical quality Cannabis in Germany can now commence.

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FDA´s new Steps regarding Voluntary Recalls

The US Food & Drug Administration (FDA) has recently issued a new draft guidance on the initiation of voluntary recalls.

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Batch Records: who needs to review?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to the review of the batch documentation?

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FDA Warning Letter: GMP Deficiencies at US Pharma Manufacturer, e.g. in Water System

The FDA has recently issued another Warning Letter to an US pharmaceutical manufacturer describing serious GMP deficiencies. This concerns among others the water system, the QC laboratory and quality assurance.

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FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.

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FDA publishes Inspection Report for Cells, Tissues and Cell Products

The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

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FDA's Office of Pharmaceutical Quality gives an Overview of its Activities 2018

The Office of Pharmaceutical Quality (OPQ) was established in 2015 within the FDA as part of the Center for Drug Evaluation and Research (CDER). The aim was to ensure the quality of medicinal products throughout their entire lifecycle, from development to commercialisation. Now, the FDA's OPQ has reviewed the year 2018 and published a 13-page report.

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GMP for Sterile Containers

Following the Q&As on what data is required for sterilization processes of primary packaging materials published in 2016, the EMA recently released the new Guideline on the sterilization of the medicinal product, active substance, excipient and primary container.

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Warning Letter for US Contract Manufacturer: Cleaning, Contamination Control and Stability Studies criticised

In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.

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