Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Part 3 - Data Integrity

As a consequence of significant GMP violations, the American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Read more about the details concerning data integrity issues listed in the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd. 


Revised USP Chapter <1225> "Validation of Compendial Methods" approved

The United States Pharmacopeial Convention (USP) approved a revised version of general chapter <1225> Validation of compendial Methods. Read more about the Validation of Analytical Procedures.


FDA Guidance for Blood Donations with regard to Ebola Virus published

In January the FDA published a guidance for industry on "Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus".


FDA Draft Guidance on Labeling of Red Blood Cell Units with Historical Antigen Typing Results

On 17 January the US FDA published a draft guidance on "Labeling of Red Blood Cell Units with Historical Antigen Typing Results". It is now open for comments.


Quality Metrics and the Way to Continual Improvement and Business Continuity

To remain 'regulatory compliant' and to ensure the continuity of product supply, systems and processes must be evaluated and the respective processes simplified and controlled. Important tools in this context are accurate Quality Metrics and Performance Indicators.


What are the current GMP Inspection Initiatives?

The ICMRA has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and FDA.


Explosion of an API Manufacturing Site: Supply of Medicinal Products Endangered

In October 2016, a facility of the company Qilu for manufacturing the antibiotic Piperacillin exploded. This accident at one production site has led to serious consequences in Germany. Read more here about the reasons and consequences of the supply shortages.


Written Confirmations - Does the procedure work as it should?

Since January 2013 all imported APIs need to be accompanied by a so called "Written Confirmation" (except a few countries with equivalent GMP standards like the US and Switzerland) which should confirm that the manufacturing site is working under GMP (ICH Q7). But how much does the system help to improve quality of APIs. An investigation of written confirmations issued by the Indian Authorities reveals some surprises. Read more about the Written Confirmations for APIs.


Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the European Pharmacopoeia

The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. Read more here about the changes in the European Pharmacopoeia regarding the control of elemental impurities in different pharmacopoeia monographs.


European Authority's Inspection Findings in the Area Validation/Qualification

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.


USP´s Intent to Revise and to Develop Elastomeric Packaging Chapters

The U.S. Pharmacopeial Convention (USP) proposes to revise its elastomeric packaging chapters. Find out more about these revisions of USP chapters <381>, <382>, <1381> and <1382>.


New and Revised Draft GMP Guidances FDA is planning to publish 2017

FDA's CDER has published a Guidance Agenda with planned new and revised Draft Guidances for 2017. Some of the planned FDA Guidances could be interesting for the GMP area.


PIC/S and European Medicines Agencies agree on Audit Cooperation

Most recently, PIC/S has published on their website a "Letter of Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme". Read more on the objective of the PIC/S and EMA agreement.


How important is "Data Governance" for your Company?

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.


USP´s Intent to Revise Chapters on Biocompatibility of Packaging Systems and Medical Devices

The U.S. Pharmacopeial Convention (USP) proposes the revision of general chapters regarding the biocompatibility of materials used in pharmaceutical packaging systems, medical devices and implants. Read more about the suggested modernization of general chapters <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.


Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 2

As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.


GMP Outlook for 2017 (Part 2)

There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.


ICH Plan to Modernise Global Good Clinical Practice Guidance - "GCP Renovation"

The ICH recently published a reflection paper on “GCP Renovation” regarding the modernization of ICH E8 (General Considerations for Clinical Trials) and the subsequent renovation of ICH E6 (Guideline for Good Clinical Practice). Read more about ICH´s Reflection Paper on the potential renovation of the ICH guidelines related to clinical trials.


Once again Critical Inspection Findings at two Indian Study Sites

Critical violations in view of the inspected studies as well as serious deficiencies in the quality management system of two Indian study sites were found during GCP inspections. Read more on the findings of the GCP inspections conducted at two Indian Sites.


FDA publishes Q&A Paper "Use of Electronic Informed Consent"

The U.S. Food and Drug Administration (FDA) recently published a Questions and Answers (Q&A) guidance on the use of electronic informed consent in clinical investigation. Read more about the FDA Guidance "Use of Electronic Informed Consent Questions and Answers".


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