GMP News - Analytical Quality Control

10.11.21

Harmonised General Chapter on Chromatography

The EDQM has announced in a press release that the harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together Ph. Eur., JP and USP.

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10.11.21

Testing into Compliance - FDA Warning Letter due to non-compliant GMP Invalidation of OOS results and Falsification of Data

A few but fundamental GMP requirements for pharmaceutical quality control laboratories are a frequent focus of regulatory inspections. During a visit to a U.S. contract laboratory, FDA inspectors found serious deficiencies in these requirements, resulting in a Warning Letter due to inadequate handling of OOS results, lack of electronic system security and data manipulation.

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03.11.21

Dissolution Testing in Pharmaceutical Analysis (Part 1)

The dissolution test is a key test parameter routinely used for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. This article will give a short overview of the test's purpose and the apparatuses according to the European Pharmacopoeia.

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27.10.21

GLP: New Data Integrity Guideline

The "OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING" document No. 22 is a comprehensive, well-written, fluently readable guide to data integrity in the Good Laboratory Practice area.

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27.10.21

Is Bracketing/Matrixing Acceptable During Generic Drug Development?

The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Questions and Answers on Quality Related Controlled Correspondence". The document contains, besides other topics, questions and answers related to bracketing and matrixing.

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20.10.21

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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20.10.21

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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13.10.21

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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13.10.21

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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13.10.21

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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06.10.21

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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06.10.21

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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05.10.21

EMA: Update of the Q&A Documents "Centralised Procedures"

In July and September 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents on centralised procedures on their website.

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29.09.21

New JP Draft 2.28 Circular Dichroism Spectroscopy Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published a Japanese Pharmacopoeia (JP) draft of a New General Test 2.28 Circular Dichroism Spectroscopy. Comments can be submitted until September 30, 2021.

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29.09.21

Four JP Drafts Related to Chromatography Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography. Comments can be submitted until November 30, 2021.

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