News

GDP in the US: New USP Chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas

A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5). It will apply to every link in the supply chain, such as manufacturers, wholesale distributors and third-party logistics providers. The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

More
GDP Audit Check List for Air Freight Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for air freight operations.

More
GDP Non-Compliance Report: No GDP conform Quality System

The competent authority of Germany (Thuringian State Authority for Consumer Protection) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. The wholesale distribution authorisation (WDA) of the company concerned was suspended. Among other things, the authority criticized the lack of a GDP-compliant quality system.

More
GDP Non-Compliance Report: No WDA without Responsible Person

On 12 July 2022, the competent authority of Germany (Regierungspräsidium Karlsruhe) added a new GDP Non-Compliance Report to the EudraGMDP database. The reason given is the fact that there is no responsible person.

More
GDP in den USA: Neues USP Chapter <1079.4> zum Temperaturmapping für die Qualifizierung von Lagerbereichen.

Ein Vorschlag für das USP-Kapitel <1079.4> Temperature Mapping for the Qualification of Storage Areas wurde im Pharmacopeial Forum, PF 48(5), zur Kommentierung veröffentlicht. Es soll für jedes Glied in der Lieferkette gelten, z. B. für Hersteller, Großhändler und 3PL-Dienstleister. Das neue Kapitel ist im Zusammenhang mit den Bemühungen der United States Pharmacopeia (USP) zu sehen, die <1079> Kapitelreihe über gute Lagerungs- und Vertriebspraxis (Good Storage and Distribution Practices) aufzubauen.

More
GDP-Non-Compliance-Report: Beschaffung bei nicht qualifizierten Lieferanten

Im August 2022 hat die zuständige rumänische Behörde einen neuen GDP-Non-Compliance-Report in die EudraGMDP-Datenbank eingepflegt. Das betroffene Unternehmen habe die GDP-Regularien nicht eingehalten. Beispielsweise seien Arzneimittel bei Unternehmen beschafft worden, die über keine Genehmigung/Erlaubnis dafür verfügten.

More
GDP-Non-Compliance-Report: Ohne verantwortliche Person keine Großhandelserlaubnis

Das Regierungspräsidium Karlsruhe hat am 12. Juli 2022 einen GDP-Non-Compliance-Report in die EudraGMDP-Datenbank eingepflegt. Als Grund wird das Fehlen einer verantwortlichen Person genannt.

More
Amazon Receives Warning Letter from FDA

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

More
GDP Audit Check List for Ocean Freight Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for ocean freight operations.

More
GDP in the US: The USP <1079> Series of Chapters on Good Storage and Distribution Practices

The United States Pharmacopeia (USP) continues its efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices. But what is the current status?

More
x
Search