UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023
A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.
Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan Preparations
In the light of the recommendations made in CHMP's final assessment report on nitrosamine impurities in sartan preparations, the European Pharmacopoeia Commission has revised 2 general chapters and 5 API monographs in a rapid procedure. Read more here about which new requirements are specified in the updated sartan monographs.
FDA stops another Delivery of Hand Sanitizer at the US Border
The U.S. Food and Drug Administration (FDA) has once again stopped a delivery of hand sanitizers with too low alcohol content. The Mexican manufacturer received a Warning Letter.
How to Characterize Viscoelastic Properties of Semisolids
The USP General Chapters - Physical Analysis Expert Committee revised the general chapter <1912> Measurement of Hardness of Semisolids. Amongst others, a definition for "yield stress" has been added.
Ph. Eur. Adopts New General Chapter on Contaminant Pyrrolizidine Alkaloids
The Ph. Eur. Commission adopted a new Ph. Eur. general chapter on contaminant pyrrolizidine alkaloids. The chapter will be implemented on 1 January 2022.
Many of the requirements laid down in the US-American GMP regulations (21 CFR 210/211) are not very specific. However, they are concretized among other things by Guidances - and by Warning Letters. Warning Letters in particular show very clearly how the FDA interprets its GMP regulations. A current Warning Letter provides information on the tasks of the Quality Assurance Unit.
FDA stops Hand Sanitizers with too low Alcohol Content at the US Border
The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.
UK Guidance on Limits for Controlled Cannabinoids in CBD Products
Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?
Can the Water Activity Test replace Microbial Testing?
According to the USP no microbiological testing of low water activity pharmaceutical products may be needed after a comprehensive risk assessment. The USP therefore revised the general chapter <1112> Role of Water Activity in Microbial Risk Assessment of Nonsterile Pharmaceutical Products.
The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.
New Approach for Dissolution or Disintegration Tests in Ph. Eur. Monographs to be Published in Supplement 10.6.
A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.
FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program
The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
FDA Warning Letter for not Adequately Testing Components prior to Use in the Manufacture
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.
Pyrrolizidine Alkaloids: USP Proposal for Contaminant Analysis
In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids announced recently, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).