GMP News - Analytical Quality Control

26.01.22

Inadequate OOS Investigations lead to FDA Warning Letter

Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

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26.01.22

USP: Analytical Instrument Qualification Stimuli published for Comments

Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comment on the USP Pharmacopeial Forum website.

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25.01.22

Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides

In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.

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19.01.22

Approved USP Chapters on Plastic Components used in Manufacturing

The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.

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12.01.22

New Ph. Eur. Draft for COC

A revised draft for the new Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published for comment in Pharmeuropa.

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15.12.21

Herbal Reference Standards - What are Active and Analytical Markers?

Active and analytical markers are used  for release and stability testing of herbal substances, preparations and HMPs. The EMA provides guidance on the selection of markers in a reflection paper on markers used for quantitative and qualitative analysis.

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08.12.21

Dissolution Testing in Pharmaceutical Analysis (Part 2)

The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. There are many requirements laid down in dissolution guidances and associated documents. To get an overview, take a look here

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08.12.21

Stimuli Article on High-Throughput Residual Solvent Analysis Using SIFT-MS

In the Pharmacopeial Forum, PF 47(6), a Stimuli article entitled "High-Throughput Residual Solvent Analysis Using Selected Ion Flow Tube Mass Spectrometry (SIFT-MS)" was published. The Stimuli article provides evaluation and validation SIFT-MS as an alternative analytical procedure to the procedures in USP chapter <467>.

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17.11.21

In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program

Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.

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17.11.21

USP-NF Stimuli Article on the Use of Apex Vessels in Dissolution Testing

In the current Pharmacopeial Forum, PF 47(6), a stimuli article entitled The Case for Apex Vessels was published.

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17.11.21

JP Drafts Related to Chromatography for Public Comments - Updated Version

We recently reported that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) had published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography. The agency has now released a slightly modified version of the draft of new General Test “<2.00> Chromatography”. Comments can be submitted until November 30, 2021.

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10.11.21

USP-NF Publishes Notice of Intent to Revise General Chapter <711> Dissolution

The Dosage Forms Expert Committee intends to revise USP General Chapter <711> Dissolution.

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10.11.21

FDA issues Warning Letter due to severe Violations of Data Integrity

Recently the FDA issued a Warning Letter due to lack of control over computer systems and violation of data integrity. During the inspection the use of multi user access to raw data files and falsification of records were observed.

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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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