Pharma GMP News of the Week September 18, 2022

Pharma GMP News of the Week: 18-September-2022

Period: September 11, 2022 to September 17, 2022

News from EDQM – At the EDQM conference in Strasbourg, the Indian Pharmacopoeia Commission will be represented

Date of news: September 12, 2022

The EDQM will host the international conference “Collaboration, Innovation, and Scientific Excellence: the European Pharmacopoeia 11th Edition” in Strasbourg from September 19–21, 2022. The Indian Pharmacopoeia Commission (IPC) will participate.

Having recently been invited to participate in the PDG pilot project for worldwide expansion (“PDG welcomes Indian Pharmacopoeia Commission to pilot for global expansion”), the IPC will attend a session on the PDG. During this session, IPC will discuss their insights on pharmacopoeial harmonization. The WHO participates as an observer in the PDG. It will bring together the European Pharmacopoeia, the Japanese Pharmacopoeia, and the United States Pharmacopoeia.


FDA published draft guidance on “Computer Software Assurance for Production and Quality System Software”

Date of news: September 13, 2022

In order to provide suggestions on computer software assurance for computers and automated data processing systems used as part of the production of medical devices or the quality system, FDA is releasing this draft document. This proposed guidance is meant to:

  • Give an explanation of “computer software assurance” as a risk-based strategy to develop trust in the automation employed in production or quality systems and indicate any areas where more rigor may be necessary; and
  • Describe several techniques and testing procedures that could be used to establish computer software assurance and offer unbiased proof to satisfy legal requirements, such as the computer software validation standards in 21 CFR part 820. (Part 820).


A definitive list of alternatives and simplified procedures for current good manufacturing practise (CGMP) of combination products has been made available by the FDA

Date of news: September 13, 2022

FDA has published a list of guidelines for producers of combination products on what data is suitable to send as part of a CGMP process to FDA based on input from the industry. The agency stated, “[Combination product] makers should turn to applicable advice as the primary reference about what information to give when submitting information on a CGMP mechanism.

All content submissions for CGMP mechanisms must also include the applicable CGMP regulation, the applicable product, any prior interactions with the agency about the subject matter, a justification and supporting scientific data, and a justification for the exemption from 21 CFR part 820. The FDA then stated that they may determine if the justification offered by the combination product maker is acceptable.


FDA published final guidance “Q3D(R2) – Guideline for Elemental Impurities” on its website

Date of news: September 14, 2022

Elemental impurities in drug products can come from a variety of sources. For example, they can be leftover catalysts that were purposefully added during synthesis, or they can be present as impurities due to interactions with processing machinery, container/closure systems, or components of the drug product. Since elemental impurities do not benefit patients therapeutically, their levels in the medication product should be kept below reasonable bounds. This advice is broken up into three sections:

• Analyzing toxicity information for potential elemental impurities

• the use of a risk-based approach to regulate elemental contaminants in medicinal products; the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological significance;


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