[Stability Testing related News – vol.70]

◆  Cloud Computing (Feb-24 ECA)

The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also organizational advantages speak for the cloud. At the same time, however, potential dangers and regulatory restrictions should also be taken into account. Nine experts from the pharmaceutical industry and regulatory authorities answer a comprehensive catalog of questions from the following GxP-relevant topics:

• Basics of Cloud Computing Technology
• Regulations and Expectations of Inspectors
• Customer-Supplier-Relationship
• Requirements for Cloud Service Providers (CSP)
• Requirements for Supplier Evaluation and Supplier Audits
• Requirements for Qualification / Validation

Find Q&As on the topic “Cloud Computing” which have been answered by the expert team.

The Experts
Frank Behnisch, CSL Behring GmbH, Marburg
Klaus Feuerhelm, Formerly Local GMP Inspectorate / Regierungspräsidium Tübingen
Oliver Herrmann; Q-FINITY Quality Management, Dillingen
Eberhard Kwiatkowski, PharmAdvantageIT GmbH, Neuschoo
Stefan Münch, Körber Pharma Consulting, Karlsruhe
Yves Samson, Kereon AG, Basel
Dr. Wolfgang Schumacher, Formerly F. Hoffmann-La Roche AG, Basel
Dr. Arno Terhechte, Local GMP Inspecorate / Bezirksregierung Münster
Sieghard Wagner, Chemgineering Germany GmbH, Stuttgart

◆  What is an FDA Post-Warning Letter Meeting? (28-Feb-24 ECA)

The U.S. Food and Drug Administration (FDA) issues Warning Letters to companies or individuals when it believes there are violations of federal law related to the safety and effectiveness of drugs, medical devices, or other products within its regulatory purview. Most of these are issued following an inspection. When reading FDA Warning Letters, you might have recognised that under the program enhancements for the Generic Drug User Fee Amendments (GDUFA or GDUFA III Commitment Letter), the facility may be eligible for a so-called Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of the company’s corrective action plans.

A Post-Warning Letter Meeting refers to a meeting that can take place between the FDA and the recipient of a Warning Letter after the letter has been issued. The purpose of such a meeting is typically to discuss issues raised in the Warning Letter, address open concerns outlined by the FDA, and establish a path forward for corrective actions. So, the company has the opportunity to present their perspective, provide additional information, and discuss corrective action plans.

It is a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA). The procedure for requesting an eligible Post-Warning Letter Meeting is also described here.

The number of pharmaceutical companies that take advantage of Post-Warning Letter Meetings with the FDA can vary.

◆  FDA Warning Letter to Drug Manufacturing Facility in Thailand (19-Mar-24 ECA)

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated 27 February 2024 to a drug manufacturing facility in Thailand for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The violations were discovered during an inspection conducted from 31 July to 04 August 2023.

The violations include failure to conduct appropriate laboratory testing, as well as deficiencies in the quality control unit’s oversight responsibilities:

• The firm failed to test drug product for identity and strength of active ingredients prior to release and distribution.
• QU failed to ensure that adequate cleaning and maintenance procedures are in place.
• GMP relevant data were not properly documented and retained.

The company committed to cease the drugs for the U.S. market. In the Warning Letter, the FDA requests clarification on the company’s intention to resume manufacturing drugs for the U.S. market in the future. The authority emphasizes the need for the firm to engage a qualified consultant to assist in achieving CGMP compliance before resuming operations. The FDA warned that failure to address the violations could result in withholding approval of new applications or refusal of admission of articles manufactured by the company into the United States.

The company was given 15 working days to respond to the Warning Letter.

Fur further information, please see the complete Warning Letter on the FDA’s Website.