GMP News - Analytical Quality Control

11.01.23

FDA Draft Guidance for Industry on Statistical Approaches for Assessing Bioequivalence

The U.S. Food and Drug Administration (FDA) has published a draft guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence". When finalized, the new document will replace the previous version, which was issued in February 2001.

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14.12.22

FDA Warning Letter: Data Integrity and Good Documentation Practice Failures

In November 2022, the U.S. FDA issued a Warning Letter to the U.S. American company Kari Gran Inc. after having inspected its site in July 2022. The Warning Letter mentions the list of cGMP observations for finished products.

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14.12.22

USP issues Chapter "Elemental Impurities-Limits" for Comments

The second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" was finalised in April 2022 and is available on the ICH website under the heading "Quality Guidelines". As a result of this revision, the chapter "<232> Elemental Impurities-Limits" of the USP has now been revised and published for comments on the USP Pharmacopeial Forum website.

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14.12.22

FDA Warning Letter to Glenmark due to Laboratory Issues

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Glenmark Pharmaceuticals Limited. During an inspection at the site in Goa, India, several GMP violations were found. The company failed to thoroughly investigate OOS results. In addition, the FDA considers the chromatographic data integration procedure as inadequate.

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07.12.22

FDA Warning Letter: Too low Ethanol Content in Hand Sanitizer Products

There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. At the end of November, a further letter was published. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs.

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07.12.22

In 2022 again Numerous FDA 483s due to Deficiencies in the Stability Program

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2022. Deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms.

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30.11.22

New Proposal for USP Chapter <711> Dissolution Published for Comments

In the Pharmacopeial Forum, PF 48(6), a proposal for a revised Chapter <711> Dissolution was published. The purpose of the revision is to replace USP Prednisone Tablets RS with a new Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

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23.11.22

FDA Warning Letter to Drug Manufacturer in Puerto Rico

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

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16.11.22

FDA Warning Letter again Highlights the Importance of Analytical Testing for Hand Sanitizers Manufacturers

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

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16.11.22

APIC: New Update of the ICH Q7 "How to do" Document

The latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. The document further on aims to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

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15.11.22

FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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02.11.22

FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

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26.10.22

Nitrosamine Impurities: Further Update of EMA's Question and Answer Document

EMA's Q&A document has recently been updated and extended. Read more here about the current limits for nitrosamines and how to proceed in case of new types of nitrosamine impurities.

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26.10.22

USP-NF Stimuli Article on Linearity of Measurement Methods

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "Linearity of Measurement Methods" was published.

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19.10.22

EDQM Publishes new Document on Revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques

The EDQM has announced the availability of a new document in the Knowledge database concerning the revised general chapter 2.2.46. Chromatographic separation techniques. It provides a comparison of the requirements included in the 10th Edition vs. the 11th Edition of the European Pharmacopoeia.

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