GMP NEWS 2020

FDA Final Rule for Antiseptic Soaps

The FDA issued a Q&A document correlated to the final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

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FDA - Bacteriological Analytical Manual, Microbiological Methods for Cosmetics

In July the FDA published the revised version of BAM: Bacteriological Analytical Manual Chapter 23 Microbiological Methods for Cosmetics.

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Stability Testing Program as a Common Problem in recent FDA Warning Letters

Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.

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Brexit: Consequences for Batch Release

During the transition period, all EU laws remain applicable in the UK. Does that mean that QP certification by UK QPs will still be valid across the EU? Not really, as a statement by the EQPA explains.

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Warning Letter for inadequate Batch Record Design and Review

The US Food & Drug Administration (FDA) recently sent a Warning Letter to a US pharmaceutical company criticising batch record design and review and quality oversight.

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New USP Chapters regarding Testing for Subvisible Particles

The USP has published the revised chapter on testing for non-visible particles <1788> as well as new monographs on the individual test methods light obscuration, membrane microscopy and flow imaging as drafts.

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EDQM Launches a New Website on Nitrosamine Contamination

Anyone who has gradually lost track of the mass of information about nitrosamine impurities can now consult the EDQM website. Read more about where to find important documents, e.g. analytical methods of determination on the new EDQM website for nitrosamines.

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Update on Ph. Eur. and Pharmeuropa

The EDQM recently announced some upcoming changes to the European Pharmacopoeia and Pharmeuropa.

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Data Integrity and Validation Issues identified during GMP Inspection

The FDA issued a Warning Letter due to non-compliance with cGMP, including Data Integrity and Validation issues, to a Canadian manufacturer of over-the-counter drug products.

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Medicinal Products for Human Use: EMA's Highlights 2019

The EMA has published the highlights for human medicines for 2019. These include 30 new APIs and one cannabis product.

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Inadequate CAPAs once more in the Focus of FDA Warning Letters

Four of five Warning Letters recently published broached the issue of handling deviations and inadequate CAPA.

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Identity Testing and Stability Studies criticised in an FDA Inspection

The first FDA warning letter of the year goes to a Chinese contract manufacturer of over-the-counter (OTC) drug products for multiple violations of current good manufacturing practice (cGMP).

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Update on the Implementation of USP´s revised Plastic Packaging Chapters

The United States Pharmacopeia recently posted an update on the delayed implementation of General Chapters <661.1> and <661.2> together with information on the revision of General Chapter <661>.

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USP Proposes New General Chapter <668> Cured Silicone Elastomers

The USP General Chapters—Packaging and Distribution Expert Committee is proposing a new general chapter <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components.

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Changes to Pharmacopeial Forum

The United States Pharmacopeia is currently introducing some changes to the format of the USP and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review.

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Pilot Programme on GMP Inspections of Manufacturers of sterile Medicines

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use.

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From GVP to GMP: MHRA´s tips for QPs to stay compliant

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.

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Report: Challenges with FDA Inspections

Report indicates persistent challenges and concerns with FDA foreign inspections.

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FDA Warning Letter for Chinese Manufacturer highlights the Importance of the Quality Unit

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.

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Warning Letter for inadequate OOS Investigations and Complaint Handling

The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.

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