A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)).  Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022.  This document is one of the most significant updates to the control of sterile and aseptic processing since the FDA Guidance for Industry (Guidance for Industry (fda.gov)) issued in 2004.  Aseptic processing is long considered a high-risk manufacturing process and this guide has grown from 16 pages to 59 pages.

Compared to the previous version, it is well organized in a manner that aligns with topics typical of a Quality Management System.  Some of the significant updates are (but not limited to):

  • Alignment with a holistic look at PQS (Pharmaceutical Quality System)
  • Wider view of a Contamination Control Strategy (CCS)
  • Review of specific technology (i.e., RABS)
  • Integration with Quality Risk Management
  • Increased focus on use and management of third parties (component suppliers and critical service providers).

The timing of this guide and aggressive implementation date is impactful as the risk of the stress in the supply chain is also under scrutiny.  As defined in FDA publication, “Drug Shortages: Root causes and Potential Solutions” (2019 Drug Shortages Report, Updated February 21, 2020 (fda.gov)) some of the root causes are listed as:

  • Root Cause 1: Lack of Incentives to Produce Less Profitable Drugs.
  • Root Cause 2: Market Does Not Recognize and Reward Manufacturers for Mature Quality Management Systems.
  • Root Cause 3: Logistical and Regulatory Challenges Make It Difficult for the Market to Recover After a Disruption.

Root Cause 1 and 3 have influence whenever new regulatory expectation are introduced.  However, the more mature understanding of Quality Risk Management can be a lever to pull to help companies focus on gaps of high risk, thus addressing some of the root causes.

Lachman has recognized these challenges and has a unique methodology to help companies see their vulnerabilities and take prospective action.  In fact, we have recognized that efficient use of the Contamination and Control Strategy actually helps reduce complexity and assists in performing proactive impact assessments. Please contact us at  LCS@Lachmanconsultants.com for additional information and scheduling of an assessment for your firm.