#GDP Tag

01 Oct

Posted at 09:34h in Blog

An update of Technical Interpretation I-SMI.TI.17e, Version 7.0 “Responsible person: requirements” has been posted on the webpage on 26.08.2024 (Responsible Person: requirements (I-SMI.TI.17e) (swissmedic.ch).

For the inspectorates, to whom all technical interpretations are primarily addressed, the technical interpretation applies with immediate effect.

Key updates in the new version include clarifications concerning the educational background and knowledge requirements for the Responsible Person (RP), especially in relation to activities that demand Good Distribution Practice (GDP) and/or Good Manufacturing Practice (GMP) experience.

To ensure compliance with the new technical interpretation the licence holder is generally required to conduct a gap analysis in order to adapt immediately to the additional requirements.

Chapter 5.2 Experience states that “GDP experience is required for the import and/or wholesale with or without market release activities, as well as export, brokerage- and/or agent activities and/or trade in foreign countries”.

The same chapter also specifies that “Brokerage, agents and trade in foreign countries-activities do not count as GDP experience for the assumption of a function as a responsible person in a company with import, export and/or wholesale activities”.

In addition, a Swissmedic press release highlights a requirement outlined in Chapter 5.5. “Chapter 5.5 requires a good knowledge of the local language for the responsible person. Establishment licence holders whose already approved responsible person does not meet these requirements are given a period of 12 months from the date of publication of the updated technical interpretation to make the necessary adjustments, either by appointing a new responsible person with the required language skills or by ensuring that the responsible person acquires the required language skills within this period”.

 

 

SOURCES:

Inspectorates website.

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19 Dec

Posted at 16:34h in Blog

The U.S. Food and Drug Administration (FDA) has organized a stakeholder call to discuss the DSCSA implementation, which took place on 29 November 2023.

The Drug Supply Chain Security Act (DSCSA) drug supply chain security requirements, ten years after its implementation, are intended to improve the FDA’s ability to detect and remove potentially dangerous drugs, whether: counterfeit, stolen, contaminated or otherwise, from the supply chain.

Among the topics covered:

  • 10-year anniversary of DSCSA implementation
  • Stabilization period and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level
  • Recent key guidances for industry related to supply chain security requirements
  • Looking ahead

Also in late November, the FDA announced that the CDER NextGen Portal (CDER NextGen) includes a DSCSA portal that enables the FDA and trading partners to communicate when the FDA requests information related to investigations of suspect or illegitimate products or during a recall.

The DSCA portal is used to:

  • Confirm basic information and points of contact for trading partners
  • Notify trading partners when they have messages from the FDA
  • Enable trading partners to respond to FDA messages and upload documents

Additionally, the DSCSA enables to:

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31 Mar

Posted at 12:03h in Blog

Compliance with Good Distribution Practice (GDP) by manufacturers and wholesale distributors is a key element in ensuring the quality and safety of medicinal products in the supply chain.

Possession of a manufacturing licence may include authorisation to distribute the medicinal products covered by the authorisation. Manufacturers performing any distribution activities consisting of procuring, holding, supplying, importing, or exporting medicinal products, should therefore comply with GDP.

PIC/S has developed an Aide Memoire “Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain” (PI 044-1)”, which can be considered a good tool for improving the understanding and performance of inspectors and a “Questions & Answers (Q&A) document regarding the PIC/S GDP Guide” (PS/INF 22/2017).

These documents were drafted by the PIC/S Expert Circle on GDP and came into force on February 1, 2023.

The Aide-Memoire consists of ten tables containing general subjects and items to be investigated during the GDP inspection of manufacturers and wholesale distributors.

Some relevant references to the following PIC/S documentation are also included:

  • PICS Guide to Good Distribution Practice for medicinal products (PE 011- 1);
  • PIC/S Guide to GMP for medicinal products (PE 009-16 (Part I)).

 

SOURCES:

Aide-Memoire, Inspection of Good Distribution Practice (GDP) for medicinal products in the supply chain

Questions & Answers document regarding the PIC/S GDP Guide (PE 011-1)

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22 Sep

Posted at 15:25h in Blog

The United States Pharmacopeia (USP) is making important changes to series of chapters on Good Storage and Distribution Practices <1079> that will impact risk mitigation strategies for storage and transportation of finished pharmaceuticals.

This chapter focuses on packaging, storage, and transportation processes that maintain drug product quality and supply chain integrity. The proposed revision identifies common risks in the storage and transportation of drug products and recommends appropriate mitigation strategies.

The new USP <1079> changes are significant and highlight the need for companies who will store, handle or transport products with label temperature requirements to meet a thorough Quality Management System (QMS). USP <1079> defines good storage and distribution practices for temperature sensitive drugs during all stages of the cold chain.

The existing chapter is titled “Good Storage and Distribution for Drug Products.” The new proposed chapter title will be – “Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.”

The <1079> Series

The current plan for the expanded series is as follows:

Chapters <1079> and <1079.2> are already effective. For <1079.3>, a draft is available for comments.

USP <1079.2>

The sub-chapter <1079.2> addresses the utility and application of mean kinetic temperature (MKT) for the evaluation of temperature excursion in controlled room temperature (CRT) and controlled cold temperature (CCT) products.

USP <1079.3>

Is a new sub-chapter. It provides background information about the science and technology of temperature and humidity monitoring over time. It also describes the available technologies and performance characteristics and provides recommendations for qualifying performance.

Sub-chapter <1118> “Monitoring Devices—Time, Temperature, and Humidity” will be omitted, as the information will be included in the new sub-chapter <1079.3>.

USP <1079.4>

<1079.4> is also a new chapter, which was first published for comments in the Pharmacopeial Forum, PF 48(5), in September 2022.

The draft versions of all proposed new chapters are available in PF Online.

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