#EDQM Tag

16 Dec

Posted at 16:56h in Blog

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a draft version of General Chapter 5.38 “Quality of Data,” which is now open for public review and can be commented on until 31 December 2024.

Impact of Technological Advancements

The draft of the new chapter refers to data generated, collected, stored, or used in the context of experimental analyses performed by quality control (QC) laboratories and highlights their increasing importance in relation to the quality assessment of medicines, particularly when these data are fed into numerical models based on chemometrics, machine learning (ML), or other forms of artificial intelligence (AI) in order to make inferences, make decisions and take action.

In this context, a defined quality standard must be applied and ensured.

Scope 

The purpose of this chapter is to focus on the “raw material” of data analysis, providing an overview of applicable data quality concepts, describing best practices for achieving a sufficiently high data quality, and reporting a summary of data governance procedures.

Quality of Data 

The text defines data as a collection of values, as “data elements” or “unit of data” with specific meaning derived from its context, including the source and generation processes.

Data elements can be classified into:

  • Primitive types (e.g., Boolean, , integers, real values, characters)
  • Composite, structured types (e.g., arrays, tables)
  • Unstructured types, not following a predefined format (e.g., text documents, natural language)

You can view and comment on the draft of chapter “5.38. QUALITY OF DATA” at: https://pharmeuropa.edqm.eu/home.

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01 Oct

Posted at 09:45h in Blog

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently published updated versions of three water monographs in the European Pharmacopoeia (Ph.Eur.):

  • Water for injections (0169)
  • Purified water (0008)
  • Total organic carbon (TOC) in water for pharmaceutical use (2.2.44)

The updates include some key clarifications:

 

Water for Injection (0169)

TOC Limit Adjustment: to reduce ambiguity, the upper limit for Total Organic Carbon (TOC) has been restricted from 0.5 mg/L to 0.50 mg/L.

Testing Requirements: the requirement to test oxidisable substances (OS) in “Sterilized Water for Injection” (SWFI) has been superseded by the introduction of the mandatory use of the total organic carbon (TOC) method B. This change simplifies the testing procedure by focusing solely on TOC measurements.

The TOC test is a state-of-the-art quantitative method that is more sensitive and non-selective than the OS test for the control of organic impurities present in pharmaceutical waters.

Residue on Evaporation: the “Residue on Evaporation” test, which measures non-volatile residue, has been changed from percentage to parts per million (ppm), offering a more standardized expression of the results.

 

Purified Water (0008)

Harmonization with WFI Standards: the TOC limit for Purified Water has also been aligned with the update to Water for Injection, now set at a 0.50 mg/L.

Standardized Units: for “Purified Water in Containers,” the measurement unit for “Residue on Evaporation” has changed from percentage to ppm, standardizing the way results are reported.

 

Total Organic Carbon in Water for Pharmaceutical Use (2.2.44)

Clarification of Water Specifications: the term “highly purified water” has been replaced with “water,” which corresponds to the specifications conductivity LF of ≤ 1.0 µS/cm at 25 °C and a TOC level of ≤ 0.1 mg/L.

Moreover, in the proposed revision of chapter 2.2.44, the reagents sucrose R and 1,4-benzoquinone R have been replaced by chemical reference substances (CRSs) to streamline the application of the TOC test.

The commenting period runs until 30 September 2024.

 

SOURCES:

The monographs can be found in draft status on the website of the European Pharmacopoeia.

More information on how to comment is available at: “Comment on drafts (Pharmeuropa)”.

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22 Sep

Posted at 15:09h in Blog

The EDQM informs that the 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available.

The latest version comprises some updated monographs which will be implemented on 1 January 2023.

Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are required to align their applications and thus the respective CEPs according to the revised monographs.

 

Responsibility

According to Directives 2001/83/EC and 2001/82/EC, as amended, it is the responsibility of the manufacturer to comply with the current version of a Ph. Eur. monograph, and therefore to update the specification when a revised monograph is issued.

In addition, the European Directorate for the Quality of Medicines & HealthCare (EDQM) ensures that CEPs always reference the latest version of the pharmacopoeia.

Besides the web notice, EDQM will contact CEP holders to provide more details on how to proceed. However, it remains the responsibility of the CEP holder to comply with the requirements of the monograph and, if necessary, to update their respective applications no later than the implementation date of the revised monograph, regardless of whether they have been contacted by EDQM.

The EDQM listed the substances covered by a CEP and for which a revised monograph will be implemented on January 1, 2023, classifying them into two categories, A and B, based on the required information

Case A:

The specification of the substance should be updated according to the revised monograph. The updated specification should be included in the next request for revision that is submitted to the EDQM.

Case B:

This case concerns amendments to the monograph which require the submission of data to the EDQM. An updated dossier demonstrating that the substance complies with the requirements of the revised monograph should be provided within three months of the EDQM contacting the CEP holder.

Where the required information has already been submitted in the approved dossier, a self-declaration is considered to be sufficient.

Source: EDQM Newsroom

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