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.
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
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>.
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.
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.
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.
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.
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.
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.
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.
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.