GMP News 2017

Elemental Impurities - Binding Risk Assessment for Authorised Medicinal Products

EMA's document on the implementation of ICH Q3D for already marketed products contains essential recommendations for marketing authorisation holders. Learn why risk assessments with regard to elemental impurities for existing marketed products are so important and how to decide about the necessity of a variation procedure.

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Maintenance Cycles of pharmaceutical Water Systems

To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?

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Swissmedic specifies Requirements for RPs

The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.

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Burkholderia cepacia - FDA Advice on Contamination Risk

Recent recalls determined FDA advice to drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products.

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Guidance for Industy: Transmission Risk of West Nile Virus from Living Donors of Cells and Tissues

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) updated  the Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)".

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Revisions of EP Chapter 5.1.8, 2.6.36, 2.6.38 and Monograph 3053

In April, the Pharmeuropa issue 29.2 was completed including the revision of chapter 5.1.8. "Microbiological Quality of Herbal Medicinal Products for Oral Use and Extracts Used in their Preparation".

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Indian Sterile Manufacturer receives a second Warning Letter

In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.

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Chinese FDA is performing more international Inspections

The China Food and Drug Administration has published the "Annual Report of Drug Inspection 2016" summarising CFDA's last year's inspection results.

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APIs from UK will need Written Confirmation

As indicated, a series of Questions and Answers on the Brexit will be provided by the EMA and the European Commission. Now, EMA has published a first set of these Q&As on Brexit.

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FDA Warning Letter due to Incorrect Sampling

Incorrect sampling has led to an FDA Warning Letter for an API manufacturer in China. The FDA inspectors criticised that around 10% of the API batches manufactured exceeded the impurity limit set. Read more about this FDA Warning Letter.

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FDA Warning Letter shows the Importance of Sampling Plans and Strategies

A recent FDA Warning Letter cited a lack of scientifically sound and appropriate sampling plans for inspection. It stated that the company had no scientific justification for the number of reserve samples selected for the yearly visual examination aimed at identifying any evidence of drug product deterioration. Similarly, the company lacked appropriate statistical sampling plans for the inspection of paper label rolls.

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Production of APIs without any Minimal GMP Standards leads to a Warning Letter for a Chinese Manufacturer

Even 17 years after the publication of the ICH Q7 Guideline, some companies still manufacture without complying with the most important binding GMP instructions and recordings. Read more about what minimal GMP requirements FDA inspectors expected but couldn't find at Changzhou Jintan Qianyao.

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Visual Control by Doctor and Patient?

To avoid a supply shortage, batches of a lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer.

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Warning Letter due to non-transparent Supply Chain of APIs

The Indian company Sal Pharma has received a Warning Letter due to serious deficiencies with regard to the procurement and storage of APIs, their distribution and disguising information. Read more about what makes the non-transparency of the API supply chain and the procedures highly suspect for the FDA inspectors.

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More Non-Compliance Statements issued by EMA

EU/EEA inspectors performed almost 2.300 GMP inspections last year. In these inspections they found an increasing number of Non-Compliance Statements.

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Warning Letter to Pharmaceutical Manufacturer in Singapore due to Leaking Sterile Containers

A manufacturer of sterile ophthalmics in Singapore has recently received a Warning Letter of the US FDA. Container leaks and the associated risk of microbial contamination were the main points of criticism.

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FDA´s Office of Regulatory Affairs restructured

FDA´s main task is to protect public health. Therefore, the FDA has to keep pace with new developments in sciences and globalisation. To keep this pace the FDA has set up an alignment programme.

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FDA Import Alert for inadequate Inspection Management

An Indian drug manufacturing facility receives a Warning Letter and an Import Alert because FDA investigators were detained from doing their job properly.

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USP Draft General Chapters on Plastic Components and Systems Used in the Manufacturing of Drug Products

The USP proposes two new general chapters <665> and <1665> to address the qualification of polymeric components used in the manufacture of pharmaceutical and biopharmaceutical APIs and drug products. Chapter <665> was previously published as Plastic Components and Systems Used in Pharmaceutical Manufacturing <661.3>. Read more about the proposals for Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products and Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products.

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Recent FDA Warning Letter: Issues with Monitoring of microbiological Environments

Because of various severe GMP violations, the FDA issued a warning letter to an American manufacturer of wound disinfactants. The authority especially criticised deviations in monitoring of microbiological environments. Read the more about the Warning Letter to Aplicare from December 2016.

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Brexit: U.K. will become 'Third Country' according to EU Statement

The EU Commission and EMA made a clear statement that after 30 March 2019, the Unit Kingdom will become a 'third country'. Both expect marketing authorisation holders to prepare accordingly.

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European authorities' viewpoint on validation deficiencies

An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.

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USP Draft Chapters on Glass Containers <660> and <1660>

Revised USP general chapters <660> and <1660> have been published for comment in the Pharmacopeial Forum. Read more about the drafts for Containers-Glass and Evaluation of the Inner Surface Durability of Glass Containers.

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FDA Warning Letter: Visible Particles and Visual Inspection

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.

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Warning Letter for Brazilian Manufacturer of Antibiotics

In the course of an FDA inspection at a Brazilian manufacturer of antibiotics, the inspector observed a few serious GMP violations which led ultimately to a Warning Letter. Read more about the FDA Warning Letter issued to the company Antibioticos Do Brasil Ltda.

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