GMP News

Safety Reporting - Responsibilities for Investigational Drugs and Devices

The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?

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FDA Guidance on Benefit-Risk Assessment

The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agency´s pre- and postmarket decisions for marketing applications. Read more about FDA´s draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.

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New Limits for Heavy Metals in Food Supplements

The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.

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Northern Ireland: EU accommodates Great Britain

The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain

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ANVISA List of approved Cannabis Products

The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.

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Change Control for Computerised Systems

Change control is mandatory to maintain the validated state also for computerised systems and is subject to inspections. What are the regulatory requirements and what is the inspection practice?

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What is the Optimal Temperature for Sanitizing Water Systems?

Thermal sanitization is still the most common method for keeping pharmaceutical water plants under microbiological control.  Some systems are stored at high temperatures - but often water systems are heated up cyclically to an elevated, germicidal temperature. Here, the question of optimal temperature often arises.

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FDA Warning Letter: Deficiencies in API / Finished Drug Product Testing and Stability Program

The United States Food and Drug Administration (FDA) has recently published a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. The letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

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Numerous FDA 483s due to Deficiencies in the Stability Program

Stability studies of pharmaceuticals are a well-established discipline and, of course, an important regulatory requirement. Nevertheless, an evaluation of the last two fiscal years shows that deficiencies in the stability program are mentioned in numerous FDA 483s.

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Update on UDI Requirements

The FDA has published a draft Guidance for Industry with the title "Selected Update for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices". What will come?

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Lack of Scientifically Sound Laboratory Controls often mentioned in FDA 483s Reports

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. An evaluation of the last two fiscal years shows that a lack of scientifically sound laboratory controls and not following/documenting laboratory controls are often mentioned in such FDA 483s.

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Inadequate Sampling Plans lead to FDA 483 Inspection Report

Sampling of materials is one of the most important processes in pharmaceutical companies. An Indian company received a so-called 483 FDA report due to inadequate sampling plans for raw materials and intermediates. Furthermore, the FDA criticises that components used in manufacturing are not tested and released prior to use.

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FDA criticizes Manual Visual Inspection

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

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Aide-Memoire from the PIC/S regarding the Inspection of Quality Risk Management

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation.

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New Updates of the Templates for Reporting Nitrosamine Contamination

Marketing authorisation holders of chemically-synthesized or biologic medicinal products are required to perform confirmatory testing after identifying a potential risk of nitrosamine contamination and report the results using specified templates. One of these reporting templates has been recently revised. Read more here about the updates to be considered in the nitrosamine contamination reporting template.

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Analytical Procedure Life Cycle - New USP Chapter <1220> published

More than a year after the publication of the draft of Chapter <1220> on Life Cycle Management of Analytical Procedures, the USP has announced the final version for 01 November.

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New FDA Draft Guidance - Microbiological Quality Control of Non-Sterile Medicinal Products

Based on the experience of the past years, the FDA has published a new draft guidance that deals with the microbiological control of non-sterile medicinal products and clarifies it by means of case studies.

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EU: further Extension of GMP and GDP Certificates

The EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose.

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FDA Warning Letter Due to Lack of Stability Data and Specifications for APIs

FDA Warning Letters frequently cite fundamental GMP deficiencies in quality control. These include lack of testing of incoming material and components and stability testing, as described in a recent Warning Letter to a Honduran medicinal product manufacturer.

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Industry 4.0 Trends in the Laboratory

Industry 4.0 will open up new opportunities in the pharmaceutical industry. But what exactly is behind the term "Industry 4.0" and what solutions can be implemented in a laboratory?

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Important Change for Entries in EudraGMDP Database

The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the EMA's Organization Management Service (OMS).

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USP Chapter on Impurities in Food Supplements

USP´s Expert Committees for Non-Botanical & Botanical Dietary Supplements and Herbal Medicines propose the elaboration of a new USP general chapter <2760> on impurities in food supplements.

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Strategic Plan of "Access Consortium" published

The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan regarding planned common approaches and goals.

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FDA´s Q&As on Generic Drug Development during the COVID-19 Pandemic

What can be done when a test or reference product batch used in the conduct of a bioequivalence study expires while the study is interrupted due to the COVID-19 pandemic? Find out in FDA´s updated Q&As on Generic Drug Development.

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Clinical Trial Information System - EMA publishes Sponsor Handbook

The go-live date for the CTIS is 31 January 2022. The System will then become the single entry point for clinical trial application submission, authorization and supervision in the EU. In order to help sponsors prepare for using the CTIS, the EMA has now published a handbook.

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