Author: andrea vpgd

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:

On October 31st, the Swiss Medicines Inspectorate published a technical interpretation of GMP Annex 1. The interpretation focuses on some of the most significant changes of the revision 2022 of Annex 1 “Manufacture of Sterile Medicinal Products”. It also addresses aspects that were already included in the previous guideline version and have consistently prompted questions.

It should be noted that the document references the revised Annex 1 of the PIC/S GMP Guideline (PE 009) about the manufacture of sterile medicinal products. This was adopted on 9 September 2022 by the PIC/S Committee and came into force on 25 August 2023 (with the exception of point 8.123, which will become binding from 25 August 2024).


Contents of the document

The document consists of a list of questions regarding chapters of Annex 1 and the corresponding answers as interpreted by SwissMedic.

It includes the following sections:


  1. Purpose and scope
  2. Basics
  3. Definitions and abbreviations
  4. Interpretation: Questions and Answers

4.1     Scope (Annex 1, Chapter 1)

4.2     Premises (Annex 1, Chapter 4)

4.3     Utilities (Annex 1, Chapter 6)

4.4     Personnel/Training (Annex 1, Chapter 7)

4.5     Production and Specific Technologies (Annex 1, Chapter 8)

4.6     Environmental & Process monitoring (Annex 1, Chapter 9)

4.7     Quality Control (QC) (Annex 1, Chapter 10)

  1. Changes to the previous version


Some questions aim to provide further clarification on the language used in the document, but there are also several inquiries regarding the assessments of single-use systems (SUS).

The document contains a total of forty-six questions and their corresponding answers.



Interpretation of GMP Annex 1 2022 (Rev. 1).

The ICH Q2(R2) Revised Guideline on Validation of Analytical Procedures” and the new ICH Q14 Guideline onAnalytical Procedure Development” were adopted by the ICH Assembly Regulatory Members during the Meeting on 31 October and 01 November 2023.

The proposed ICH Q2(R2) and ICH Q14 guidelines are intended to complement the ICH guidelines Q8 to Q12, as well as the ICH Q13 guideline for continuous manufacturing.


ICH Q2(R2)

ICH Q2(R2) presents elements included as part of registration applications. It provides guidance on selection and evaluation of the various validation tests for analytical procedures.

The comprehensive revision of the ICHQ2(R1) guideline was made to include more recent application of analytical procedures and to align the content with Q14 guideline.

The validation of an analytical method used for the assessment of the quality of drug substances and drug products, throughout entire life cycle was considered, describing considerations for the development of multivariate analytical procedures and for real time release testing (RTRT) or near infrared spectroscopy (NIR), which were not previously considered in the ICH Q2 guideline but are already used in practice.

Two annexes on the selection of validation tests based on the analytical method and with illustrative examples for analytical techniques have been added.



ICH Q14 guideline aims to harmonise scientific approaches to analytical method development and describes the principles for their process description, change management and submission requirements for a minimal and extended approach. Applicants should be supported in not submitting analytical validation results in isolation but presenting them in the context of a performance evaluation against corresponding analytical development results.

The new guideline is intended to improve communication between industry and regulators and achieve a more efficient, science-based, and risk-based approval. This in turn should facilitate post-approval change management of analytical procedures.