When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?
Even animals with legs can keep the regulatory authorities busy. In December, a US manufacturer received a Warning Letter, the first section of which deals with deficiencies in the area of pest control.
In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.
The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.
The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.
The EMA has received a grant of ten million euros from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA).
As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.
Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.
The House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing, which focused on the comparative frequency and quality of FDA inspections for foreign versus domestic drug manufacturers. Read more in our GMP News.
The European GDP Association offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. Several interesting topics have been discussed over the last few weeks. To get an idea, take a look here.
During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview first published a few months ago has now been extended.
Chapter 4 of the EU GDP Guidelines points out that good documentation constitutes are an essential part of the quality system. In this article, you will find a checklist to verify the minimum implementation.
In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.
The FDA has revised its Draft Guidance for Industry "Conducting Remote Regulatory Assessments - Questions and Answers", providing answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals. The firm failed to conduct proper analytical testing of incoming API lots and relied solely on supplier COAs without verifying the information. Additionally, there was a lack of documentation for the stability program.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 19: A non-(GXP-)qualified PAAS could change the versions of some of its generic microservices used by the application to be deployed as a GXP SAAS. Changing the versions of such generic microservices could be beyond the control of the SAAS provider. What would be required to make this scenario GXP-compliant?
The draft guideline "Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products - VICH GL 60" of the VICH can still be commented on until the end of March 2024. Comments can be submitted via the U.S. FDA website, for example.
In December 2023, the Questions & Answers (Q&A) documents related to centralised procedures were revised again and published on the European Medicines Agency (EMA) website. The list of Q&As, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to any questions that may arise at different stages of the centralised marketing authorisation application.
In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.
The Supplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 01 July 2024. All CEP holders are required to harmonise their specifications and thus the respective CEPs with the new monographs.
Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 18: What is the value of a "validation" performed by a CSP on its own for the services it provides?
We recently reported on a case in which the failure to respond led to a Warning Letter. The U.S. Food and Drug Administration (FDA) has now published another incident that also goes in this direction. The FDA had planned an inspection at a manufacturing facility in Thailand, but all efforts to contact the firm were unsuccessful.
India's Ministry of Health has published revised pharma manufacturing rules and introduces 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products'.
On 26 January 2024, the European Medicines Agency (EMA) has published the ICH Q14 Guideline on analytical procedure development - Step 5. The date for coming into effect is 14 June 2024.
