US FDA: Draft on Data Integrity for BE/BA Studies published
At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.
Warning letter to South Korea - from process validation to analysis of starting and raw materials
At the beginning of April, the FDA published a Warning Letter to a manufacturer from South Korea. This contained a whole series of deficiencies, including a lack of validation of manufacturing processes and quality control measures, as well as a lack of testing of ingredients such as glycerine for the absence of ethylene and diethylene glycol.
FDA Form 483 lists 10 Observations made during an Inspection of an Indian Drug Manufacturer
On 09 April 2024, a new FDA Form 483 to a company in India was published. The document lists a total of 10 observations made by the FDA investigators during the inspection in March 2024 of the firm's facility located in Baddi.
FDA Warning Letter: Missing Ongoing Stability Studies for APIs
In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.
Ethylene and Diethylene Testing - Warning Letter and Regulatory Activities
Since 2022, the series of Warning Letters, but also the activities of the authorities on the subject of testing for ethylene and diethylene glycol, has not stopped. The FDA recently published another Warning Letter.
The new AQCG ECA AIQSV Guide: Download, Training, Comments
The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. It is intended to be a practical guide for risk-based instrument qualification and system validation.
USP plans new Chapter on Process Analytical Technology (PAT)
The United States Pharmacopeia (USP) is developing a new General Chapter dedicated to Process Analytical Technology (PAT), aiming to provide guidance on its definition, attributes, enablers, and practical applications in the pharmaceutical industry. Comments on the proposed outline are due to the USP by 28 April 2024.
FDA sends Warning Letter to Canadian OTC Manufacturer
A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.
Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data
A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.
FDA Warning Letter to Drug Manufacturing Facility in Thailand
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.
EMA/CMDh: Appendix 1 for Nitrosamines Updated Again
The nitrosamine Q&A document "Questions and answers for marketing authorization 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" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.
The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.
In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.
After the ICH and the EMA had already made the documents available for download in December and January respectively, the FDA has now announced the availability of the final guidances for the industry entitled "Q2(R2) Validation of Analytical Procedures" and "Q14 Analytical Procedure Development."