GMP News

Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

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Warning Letter: FDA criticises Missing Re-Validation

The FDA has recently issued a Warning Letter to criticize, among other things, the lack of revalidation at a pharmaceutical manufacturer. At first sight, this seems surprising, as it replaces stage 3 of the process validation lifecycle, the Continued Process Verification, the periodic re-validation that was common in the past (exceptions are made in the sterile area). What are the reasons for FDA's request?

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Warning Letter about Deficits in Aseptic Manufacturing - Part 1: Cleanroom Behaviour and Materials in the Aseptic Area

Deficiencies in aseptic production have led to a Warning Letter for the Japanese company Takeda Pharmaceutical Company Limited. Part 1 of the News deals with inadequate cleanroom performance and inadequate controls of materials used in aseptic production.  What were the reasons for this Warning Letter?

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Inspection Observations on Supplier Qualification because of Inspection at Supplier

A US company received an FDA Warning Letter because of problems at their CMO that were not detected in time.

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New USP Draft Chapter on Plastic Components Used in Manufacturing

In the current Pharmacopeial Forum revised drafts of the two previously published USP Chapters <665> and <1665> on plastic materials used in pharmaceutical manufacturing have been published for comment.

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Brexit: How to import Medicines into UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period.

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FDA Warning Letters: Structure and the "Lessons Learnt" Effect

The unpopular deficiency letters of the FDA contain numerous standard formulations and follow a fixed scheme in their structure. Read more here about the structure of the Warning Letters and why their reading can be very useful in preparing for an FDA inspection. 

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Microbiological Environmental Monitoring at the Focus of an FDA Warning Letter

Deficiencies in microbiological environmental monitoring have led to a Warning Letter for the Korean company Samchundang Pharm Co. What deficiencies were found at the inspected company and what measures were required to remedy them?

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Swissmedic resumes Inspections

Swissmedic has announced that inspections will again be carried out on site, provided that appropriate protective measures are observed.

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USP publishes draft of new chapter <1220> Analytical Procedure Life Cycle

The USP published the long awaited draft of the new chapter on the Lifecycle of Analytical Methods in the Pharmacopoeal Forum.

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WHO Publishes Another Draft Guideline on Health-Based Exposure Limits

In June you could already read about a WHO draft guideline on the topic of limit values in cleaning validation. This draft has now been significantly revised and re-issued with a new title "Point to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation". What changes have been made?

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Survey Results on the Use of Electronic Documentation in Equipment Qualification

Since at least the end of the 80s, equipment qualification has been an official expected standard. In the meantime, electronic documentation systems have been widely used. Nevertheless, pharmaceutical companies often still work with paper, especially in the field of equipment qualification. Would it not be possible to use more qualification documents electronically? This is something we wanted to find out from you. 14 questions were asked to give an overview of this topic.

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Hormones and Homeopathics on the same Equipment: Warning Letter

A manufacturer of homeopathic drugs and hormone preparations in the USA has received a Warning Letter from the FDA due to several GMP violations. Among other things, highly active drugs were produced on the same equipment as the other products.

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EU: Checklist for Brexit Preparation

The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK.

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How are FDA Inspections and Applications impacted by COVID-19 Restrictions?

The FDA has published a Q&A document with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.

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Questions & Answers: Semi-Automated Visual Inspection

The webinar on semi-automated visual inspection of parenteralia on June 16, 2020 met with great interest. In addition to many basic questions regarding visual inspection, specific questions about semi-automated inspection were asked and answered during the webinar. Here you can find a short selection.

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A Lifecycle Approach for Analytical Instrument and Systems Qualification

In July 2018, the ECA Analytical Quality Control Group published version one of its guideline on Analytical Procedure Lifecycle Management (APLM) in support of the development of USP <1220> and the ICH revision of Q2(R2) and the newly proposed Q14.

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PIC/S publishes Q&A document on Health Based Exposure Limits and Cross-Contamination

In the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper?

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European GDP Association nominates new Board Member

The European GDP Association, representing more than 2,200 professionals from across the globe, has extended its Board. Emil Schwan was invited to join the Board and accepted his nomination.

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GDP Monograph for Active Substances: Interactive PDF now available

The "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published recently as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. An interactive PDF of the document is now accessible free of charge in the member's area of the European GDP Association.

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PIC/S publishes Aide-Memoire for the Inspection of Health Based Exposure Limit

In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) re-issued document PI 052-1. What is in it?

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Can the Application of Safety Features be outsourced?

Safety features may be applied by external manufacturers and suppliers. This has now been clarified in a Question and Answer document.

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Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a firm that manufactures and distributes OTC products. The Warning Letter summarizes significant violations of current Good Manufacturing Practice (CGMP). The company failed, amongst others, to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. Furthermore, the laboratory management could not provide an adequate explanation for several unofficial HPLC injections.

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Data Integrity Issues at the Focus of a Warning Letter for a US-American Company

Data integrity issues remain at the focus of FDA inspections. Insufficient or missing controls to ensure the integrity of electronic test data were one of the reasons for the Warning Letter issued to the American company Stason Pharmaceuticals.

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WHO Pharmaceutical Water Guideline: Revision goes into next Round

The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.

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