GMP News

Major Reform of UK Clinical Trials Regulation

The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

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EMA's Q&As on Raw Data from Clinical Trials

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

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FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.

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USP Draft Chapters for Glass and Plastic Packaging Systems

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

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Which Test Sets are used in the 100% Visual Inspection?

In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account.

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Cloud Computing: Multi-tenant provisions of SAAS and Change Control

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 9: The multi-tenant provision of SAAS is accompanied by a source code basis for all customers. This implies that all customers must have the same software version irrespective of whether or not a customer accepts a certain change. Is this compatible with GxP?

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Pharmeuropa: Revised Chapter 2.9.1. "Disintegration of tablets and capsules" published for comment

In the Pharmeuropa issue 35.2, a proposal for a revised chapter 2.9.1 "Disintegration of tablets and capsules" was published. The deadline for submitting comments is 30 June 2023.

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Cloud Computing: Which contents must be covered by the service provider's change control?

Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 8: Which contents must be covered by the service provider's change control and in which way must the contract giver be integrated into this system?

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APIC: FAQs on Data Integrity

In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

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FDA Warning Letter: Inadequate API testing

In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

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FDA Warning Letter to Indian Manufacturer: Glycerine used in Manufacturing not Tested according to USP

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an Indian company, registered as a manufacturer of OTC and homeopathic drug products. Some of the formulations contain high percentages of glycerin, but this high-risk component was not adequately tested according to the USP requirements. Thus, it was not ensured that the relevant safety limits for the levels of diethylene glycol or ethylene glycol were met.

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FDA's Guidance on Quality Considerations for Clinical Research with Cannabis

The FDA published the final guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.

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Revision of the Ph. Eur. Monograph Hop Strobile

Hop (Humulus lupulus) is commonly known for its use in brewing beer. However, it is also used as a herbal drug. The Ph. Eur. Monograph Hop Strobile has now been proposed for revision.

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St. John's Wort: Updated EU Herbal Monograph

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

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Declaration of Herbal Substances & Herbal Preparations in HMPs

The HMPC issued a concept paper on the revision of the Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs).

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GDP in the US: USP Chapter and Stimuli Article on MKT

In the Pharmacopeial Forum, PF 49(2), a proposal for a revised USP General Chapter <1079.2> "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products" and a Stimuli Article "The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb" were published. Comments can be submitted until 31 May 2023.

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Competent Authority of Czechia issues four new GDP Non-Compliance Reports

After the public access to the GDP Non-Compliance Reports in EudraGMDP did not function for several weeks, reports can now be accessed again. In the meantime, four new documents have been added by the competent authority of Czechia. In all cases, the companies did not provide approved storage facilities.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 1

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 1 here.

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FDA Warning Letter to Californian Drug Manufacturer

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturer in California. The FDA blames the company of various CGMP violations, particularly in the areas of release testing, sampling, stability testing and process validation.

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Is it possible to monitor for Biofilm Infestation using online TOC Measurement?

In pharmaceutical water systems, the TOC value (Total Organic Carbon) is usually determined online. Since bacteria consist mainly of hydrocarbons, the question arises whether TOC monitoring can also provide information about the microbial status of the water system.

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Manufacture of IMPs - When is it Reconstitution?

Following the Brexit, the UK clinical trials regulations differ from those in the EU Member States. Therefore, the British MHRA published on their blog a post on the manufacture of Investigational Medicinal Products (IMPs).

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Clinical Trials Regulation - Version 6.4 of the Q&As

The European Commission published an updated Version 6.4 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). A new Q&A has been added for the case where the sponsor of a clinical trial is not the product owner of the IMP and should not have access to the quality IMPD in order to protect commercially confidential information.

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How can Sponsors Demonstrate Oversight for Delegated Activities?

A new Q&A at EMA´s Good clinical practice (GCP) website addresses how sponsors can demonstrate oversight for those activities that are delegated by a written contract.

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Final GCP Guideline on Computerized Systems and Data Integrity

The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.

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Laboratory Data Integrity issues once again caused a Warning Letter

In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.

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