USP is Announcing a Proposal to Modify the Glass General Chapter <660>
Due to the current shortages of glass vials the USP is announcing a proposal to modify General Chapter <660> Container— Glass. In particular, the revision is anticipated to remove the glass classifications based on composition.
Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures
The European Directorate for the Quality of Medicines & HealthCare (EDQM) issued a press release indicating that public consultation on two Ph. Eur. chapters on pharmaceutical technology procedures has been started. These are the revised general chapter 2.9.3 "Dissolution of tablets and capsules" and the new general chapter 2.9.55 "Characterisation of powder behaviour during compression".
FDA Warning Letter: Acetaldehyde and Acetal Impurities in Hand Sanitizers
The U.S. Food and Drug Administration (FDA) has published two Warning Letters to manufactures of hand sanitizer drug products. In both cases, acetaldehyde and acetal impurities at unacceptable levels were found in several lots. The agency is concerned, because acetaldehyde is considered to be genotoxic, and potentially carcinogenic.
USP Proposes to Add Flexibility in the Selection of Parenteral Packaging
To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass.
FDA Warning Letter caused by Lab Data Integrity issues
In December 2022, the U.S. FDA issued a Warning Letter to the Brazilian company "Nortec Quimica SA" after having inspected its site in Rio de Janeiro in July 2022. Significant violations of cGMP regulations for Active Pharmaceutical Ingredients (APIs) are listed and a long list of Data Integrity remedation activies is required.
USP: Further Updates on "Residual Solvents" published for Comments
The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.
FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations
The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.
GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act
The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.
Revision of USP Chapter <1236> Solubility Measurements Published for Comments
In the Pharmacopeial Forum, PF 49(1), a proposal for a revised USP General Chapter <1236> Solubility Measurements was published. Based on comments received, some revisions were made in addition to those proposed in PF 48(2).
USP: Possibility to Comment on the "Residual Solvents" Chapter
As recently reported, the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents)" has been updated and can be consulted on the ICH website under the section "Quality Guidelines". As a result, the USP chapter "<467> Residual Solvents" has now been revised and published for comment on the USP Pharmacopeial Forum website.
EMA/CMDh: Update of the Q&A Document on Nitrosamines
The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.