Pharma Talk

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 The following question is one of a series of questions that we will publish in further GMP News articles on this site in the coming weeks. Question 24: If the pharmaceutical user has data in the cloud, what type of system is it? Is this an open or closed system according to 21 CFR Part 11? - Basics of Cloud Computing Technology...

The EDQM has announced the addition of a new FAQ to its existing series, addressing the system suitability test (selectivity) in chromatographic assay procedures. This update comes in response to user inquiries received via the HelpDesk. The new FAQ specifically references the phrase, “as described in the test for related substances with the following modifications,” which appears in many monographs. The answer clarifies that in such assays, the SST is part of the analytical procedure. Consequently, "the reference solution prepared for the selectivity test, as part of the purity test, must be analysed in the assay even if this solution is not expressly mentioned under ‘ASSAY’." In a press relase dated 17 December 2024, the EDQM writes: "This addition is expected to enhance the support to users by clarifying the SST requirements that apply to assays by chromatographic procedures when an analytical procedure similar to the related substances test is used." Click here ...

Latest update on 08.01.2025 The nitrosamine 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' of the EMA/CMDh contains three annexes (Appendix 1-3) in the current version of July 2024. These documents are published on the EMA website and can be viewed under 'Questions and Answers'. Appendix 1 was compiled by the 'Non-clincal Working Party (NcWP)' and the information provided there for the acceptable intakes (AIs) is based on the 'Carcinogenic Potency Categorisation Approach (CPCA)'. InDecember 2024, new substances were added to Appendix 1, which consists of a tabular list of substances, and some existing entries in the list were updated. These are marked in red in the list of Acceptable Intakes (AIs) and are clearly recognisable. These include New N-nitroso-anabasine N-nitroso-anatabi...

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There is relatively little information on FDA requirements for equipment qualification. You can find guidance in the FDA Guidance for Industry General Principles and Practices: Process Validation on 'DQ', 'IQ' and 'OQ'. However, the terms 'DQ', 'IQ' and 'OQ' are not mentioned there. A footnote refers to the ASTM standard E2500. But what does the implementation look like in practice in companies? A current Warning Letter gives some clues.  What is it about? An over-the-counter (OTC) drug manufacturer is criticised under 21 CFR 211.113 for finding germs in water monitoring. This water was used to manufacture OTC drugs and to clean the equipment. Among other things, the FDA criticised the inadequate qualification of the water system. It refers to installation and functional qualifications carried out by the manufacturer in 2019, whereby data collection was only completed three years later. However, the data was not analysed. Subsequently, th...

 FDA warning letters, the FDA sometimes advises the employment of a consultant in order to remedy the deficiencies addressed. But what are the requirements regarding such consultants from a GMP perspective? The FDA's CGMP guidelines provide instructions on this in 21 CFR 211.34: "Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide." Fortunately, the EU GMP Guideline Part I includes almost the same requirements in chapters 2.23 and 2.24: Consultants should have adaquate education, training and experience, or any combination thereof, to advise on the subject, for which they are retained. Records should be maintained stating the name, adress, qualification, and type of se...

The ICH Secretariat announced the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM). The ICH Assembly approved the updated Annex on 30 October 2024. The Q&As have been updated by removing outdated text and rephrasing the Q&As considered in view of the implementation of ICH Q8, Q9 and Q10, with minor additions to address minor content gaps in the document. Furthermore, minor edits have been made to improve the readability of the document. Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the ICH Q8(R2), Q9 and Q10 Guidelines have resulted in the need for some clarification. The Questions and Answers developed by the Quality Implementation Working Group (IWG) are intended to facilitate the implementation of the Guidelines, by clarifying key issues. Besides the core topics Pharmaceutical Development, Quality Risk Management, Pharmace...

The topic of "risk" appears 16 times in FDA's Process Validation Guidance. Annex 15 to the EU GMP Guidance clearly states: "As part of a quality risk management system, decisions on the scope and extent of qualification and validation should be based on a justified and documented risk assessment of the facilities, equipment, utilities and processes." In their guidance, the FDA also recommends a risk-based approach to determining critical parameters. But how should inadequately validated processes be handled in retrospect? The FDA comments on this in a recent Warning Letter. The FDA criticized Outin Futures Corp. for failing to validate the homogeneity of the API in an intermediate for its over-the-counter (OTC) drugs. Deficiencies in the cleaning validation were also criticized. In response, Outin sent a validation protocol to the FDA to demonstrate the homogeneity of the active ingredient. A validation protocol for cleaning validation was also included in the r...

The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, marketing authorisation holders (MAHs) can now submit data to routinely report shortages of centrally authorised medicines. This marks the start of a transition period that will end on 2 February 2025, when the use of the platform becomes mandatory. Marketing authorisation holders can now use the platform to report shortages of centrally authorised human medicines. The launch of the functionality for routinely reporting shortages will be followed by the release of the second version of the ESMP in February 2025 with the full scope of functionalities for MAHs and national competent authorities (NCAs). By then MAHs and NCAs will also be able to submit data on the supply, demand and availability of centrally and nationally authorised medicines during crises and preparedness actions led by EMA's Executive Steering Group on Shortages and Safety of Med...

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 The following question is one of a series of questions that we will publish in further GMP News articles on this site in the coming weeks If quality-related services are outsourced by the pharmaceutical company to third parties, the contractors must be assessed for their competence and suitability; this assessment must be avail...