The European Medicines Agency (EMA) has published two new Q&As on its website related to good manufacturing practice and good distribution practice. These are aimed specifically at wholesalers and brokers and provide information on how to recognise suspicious offers and take appropriate action.
As part of an internationally coordinated operation, Swissmedic, the Federal Office for Customs and Border Security (FOCBS) and Swiss Sport Integrity (SSI) inspected over 1,000 suspicious postal shipments. Numerous counterfeit or non-authorised medicinal products were seized during the operation.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two documents for inspectors related to remote assessments. Although the documents are primarily intended for GMP inspectors, they can also be useful for the GDP area (with appropriate modifications).
If the outcome of an inspection is that a wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into the EudraGMDP database. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports issued in 2024, including the corresponding reasons for their issuance.
On 16 December 2024, the European Commission, the HMA and the EMA, published an updated version of the Union list of critical medicines and the updated version of the corresponding Q&A document.
The United States Pharmacopeia (USP) has issued a pre-posting notice to inform of the anticipated publication of General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products. This provides early access to the chapter due to strong regulatory interest in several Climatic Zone IVb countries.
We recently reported on two GDP Non-Compliance Reports issued by the Romanian authorities. Now, an additional report concerning a Romanian wholesaler has been published in the EudraGMDP database.
In October 2024, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced on its website the new version 3 of its GDP guide 'Good Distribution Practices Guide for Pharmaceutical Excipients'.
Swissmedic has updated the Directive "Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood". Version 4.0 was approved on 21 October 2024.
BioPhorum recently published a new document entitled "Restarting the inbound supply chain: a BioPhorum Supply Partnering and Relationship Management position paper".
The Competent Authority of Romania (National Authority Of Medicines And Medical Devices) has issued two new GDP Non-Compliance Reports related to human medicinal products in the EudraGMDP database.
Swissmedic has made the new SwissGMDP database publicly available. The database lists all establishment licence holders domiciled in Switzerland, as well as all the operating sites and activities that are authorised. It is also possible to consult the GMP and GDP certificates.
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published a new "Wholesalers & manufacturers guidance following agreement of the Windsor Framework". The text contains guidance for wholesalers, Responsible Persons (RPs) and Responsible Persons for Import (RPis) in order to implement the arrangements of the Windsor Framework for human medicines.
During several GDP events organized by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview, initially published a few months ago, has now been further expanded.
Chapter 10 of the EU GDP Guidelines describes the requirements for brokers. In this article, you will find a checklist to verify the minimum implementation.
Swissmedic has published an updated version of the Technical Interpretation "Responsible Person: Requirements (I-SMI.TI.17e)", which includes numerous clarifications. Although compliance with the previous version typically remains sufficient, some situations may require immediate action from license holders. The new interpretation is effective immediately.
The Parenteral Drug Association (PDA) has published a new document - Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users. It provides details on temperature control, monitoring and security, and data management, with a focus on supply chain management. Furthermore, the document covers supply chains in Europe, Africa, Brazil, U.S., Canada and China.
The competent authority of Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. During a reinspection, it was found that the issues from the inspection in October 2023 had not been resolved. Furthermore, new critical and serious findings were identified.
On 10 July 2024 the European Commission's Health Emergency Preparedness and Response Authority (HERA) published a technical report evaluating vulnerabilities in the supply chain for medicines listed in the Union list of critical medicines.
The EU Commission published a report on the latest trends in the falsification of medicinal products. The report makes an attempt to include an assessment of whether the Falsified Medicines Directive is effective in preventing falsified medicines from entering the legal supply chain.
On 18th of June 2024, the EMA has issued templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). Marketing authorization holders in the European Union/European Economic Area are encouraged to create Shortage Prevention Plans to minimize the risk of medicinal shortages.
The Council of Europe has adopted a new recommendation to report the disappearance of medicines. The aim is to protect public health by promoting better cooperation and reporting between the relevant authorities.
The competent authority of Czechia (State Institute for Drug Control) has issued a new GPD Non-Compliance Report - the first report published in the EudraGMDP database in 2024.
According to Chapter 9 of the EU GDP Guidelines, it is the responsibility of the supplying wholesale distributor to protect medicinal products during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. In this article, you will find a checklist to verify the minimum implementation.
On 24th of May 2024, the EU member states adopted the European Supply Chain Law which requires companies of a certain size to monitor and prevent negative impacts on human rights and the environment from their supply chain activities.
According to Chapter 8 of the EU GDP Guidelines, self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures. In this article, you will find a checklist to verify the minimum implementation.
The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. The new version contains four new Q&As compared to the previous version, which mainly cover the tasks of parallel traders when dealing with safety features during repackaging.
The European Medicines Agency (EMA) has published a new Q&A document on Remote RP activities. Remote activities by the Responsible Person may be permitted, but should occur within the EU/EEA or Northern Ireland in all cases.
Almost 100 participants attended the ECA Webinar "GDP Update 2024" in March. Many interesting aspects were discussed in the Q&A session. The speaker, Dr. Christian Grote-Westrick, has answered the questions in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.
According to Chapter 7 of the EU GDP Guidelines, any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. In this article, you will find a checklist to verify the minimum implementation.
The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.
Almost 100 participants attended the ECA Webinar "GDP Update 2024" in March. Many interesting aspects were discussed in the Q&A session. The speaker, Dr. Christian Grote-Westrick, has answered the questions in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 1 here.
According to Chapter 6 of the EU GDP Guidelines, all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. In this article, you will find a checklist to verify the minimum implementation.
The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). But where actually to find reliable information on whether a particular company is in possession of such an authorisation or GDP certificate? Depending on the location of the company in question, certain databases are available for searching.
According to Chapter 5 of the EU GDP Guidelines, all actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain. In this article, you will find a checklist to verify the minimum implementation.
Swissmedic, the Swiss national authorisation and supervisory authority for drugs and medical products, has published a new document on "Shipment under Quarantine". It clarifies some situations in which a shipment under quarantine of active substances, intermediate drug products and finished drug products would be acceptable to inspectors.
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.
The Austrian Agency for Health and Food Safety has entered a new GDP Non-Compliance Report into the EudraGMDP database. This affects an active substance (API) distributor.
Falsified medicines do not meet the standards of safety, efficacy and quality as are required and may pose a serious risk to public and animal health. That is why the topic is explicitly addressed in the EU GDP guidelines. Despite all precautions, several examples have recently come to light in which counterfeit medicines have entered the legal supply chain.
If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports published in 2023 and the respective reasons for issuing these reports.
According to Chapter 3 of the EU GDP Guidelines, wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In this article, you will find a checklist to verify the minimum implementation.
Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.
The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.
The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.
Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.
The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. In this article, you will find a summary of recent developments.
The Competent Authority of Germany (Regierungspraesidium Freiburg) has entered a new GDP non-compliance report into the EudraGMDP database. The list of deficiencies identified is quite long and the deviations run through almost all chapters of the EU GDP Guidelines.
The Competent Authority of Czechia (State Institute For Drug Control) has entered a new GDP Non-Compliance Report into the EudraGMDP database. A wholesale distributor seriously violated the GDP requirements by failing authorized storage facilities.
Chapter 2 of the EU GDP Guidelines defines the qualification requirements, tasks and responsibilities of all staff and the Responsible Person (RP). In this article, you will find a checklist to verify the minimum implementation.
GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport and storage of the active pharmaceutical ingredients (APIs) used for production. But what general requirements actually apply to the GDP-compliant storage of APIs for medicinal products for human use or veterinary medicinal products?
Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany) has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research (CDER) has provided a webinar on the Drug Supply Chain Security Act (DSCSA) implementation.
According to Chapter 1 of the EU GDP Guidelines, wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. In this article, you will find a checklist to verify the minimum implementation.
The European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document to facilitate identification of recommendations on critical shortages of medicinal products.
The Austrian Medicines and Medical Devices Agency has entered a new GDP Non-Compliance Report into the EudraGMDP database. The authority writes that major deficiencies were detected in the quality systems of a wholesale distributor, also related to the lacking awareness of the Responsible Person. As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.
GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport of the active pharmaceutical ingredients (APIs) used for production. But what general requirements actually apply to the GDP-compliant transport of active ingredients for medicinal products for human use or veterinary medicinal products?
On 09 October 2023, the Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.
The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a series of deviations from Good Distribution Practice were found. This led to a suspension of the company's authorisation for procuring, holding, supplying and storage by contract of human medicinal products.
The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.
Swissmedic plans to bring a SwissGMDP database into operation, which will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The database will make it possible to view the GMP/GDP status of a company easily and free of charge.
To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.
In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.
At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.
The required storage conditions for medicinal products must always be met. If deviations are discovered after the product has left the warehouse, a recall may be the consequence. This is shown by an example from the US, which is about possible pest control problems and temperatures in excess of the storage condition instructions on the product labeling.
The U.S. Food and Drug Administration (FDA) has published a new guidance document entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies". The document focuses on the enforcement of the enhanced drug distribution security requirements that will become effective on 27 November 2023. The authority grants a one-year extension as it does not intend to take action to enforce the requirements until 27 November 2024.
The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.
In the context of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."
The European GDP Association, representing more than 4,300 professionals from across the globe, 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.
The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act". Comments can be submitted until 28 August 2023.
The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.
The United States Pharmacopeia (USP) intends to revise several chapters of the <1079> series in response to the omission of General Chapter <1118> Monitoring Devices—Time, Temperature, and Humidity.
During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.
More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 3 here.
The European Medicines Agency (EMA) has published the annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022. An updated work plan 2021-2023 has also been issued.
Just recently, you could read about the Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 and 22 February 2023. A summary of the GDP part was now published on the MHRA Inspectorate blog.
After the competent authority of Czechia (State Institute for Drug Control) had just recently added four GDP Non-Compliance Reports to the EudraGMDP database, another one was added at the end of April 2023.
More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.
In the Pharmacopeial Forum, PF 49(2), a proposal for a revised USP General Chapter <1079.2> "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products" and a Stimuli Article "The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb" were published. Comments can be submitted until 31 May 2023.
After the public access to the GDP Non-Compliance Reports in EudraGMDP did not function for several weeks, reports can now be accessed again. In the meantime, four new documents have been added by the competent authority of Czechia. In all cases, the companies did not provide approved storage facilities.
More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 1 here.
The U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". The document clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". It is primarily intended to assist trading partners in meeting verification obligations.
The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.
The Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) were held on 21 and 22 February 2023. The first day of the conference focused on regulatory developments in the area of Good Distribution Practice (GDP).
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document. Both documents entered into force on 01 February 2023.
On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.
A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).
The United States Pharmacopeia (USP) has published a Notice of Intent to Revise General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products. With the revision, the inclusion of temperature excursion limits for climatic zone IVb is being proposed. In a Stimuli Article, the rationale for the revision is outlined. Both documents were now pre-posted, to allow stakeholders additional time for reading and understanding.
The German Federal Court of Justice (BGH) has submitted questions to the Court of Justice of the European Union (ECJ) on the permissibility of selling pharmaceuticals via Amazon. Specifically, the issue is whether a pharmacist who sells pharmaceuticals on an Internet sales platform is in breach of the data protection provisions applicable to health data. In addition to the data protection aspects (DSGVO), the two underlying legal disputes also concern provisions of the German Medicines Act (AMG), the German Drug Advertising Act (HWG), the Pharmacy Operations Regulation (ApBetrO) and the Professional Code of Conduct for Pharmacists.
According to the EU GDP Guidelines, wholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public. But what is the rationale for this point and how are the requirements to be implemented?
Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.
Wholesale distributors must have suitable and adequate premises and storage facilities. But what are actually the specific requirements according to the EU GDP Guidelines?
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.
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.
If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. We have prepared an overview of the GDP Non-Compliance Reports published in 2022 and the respective reasons for issuing these reports.