{"id":8198,"date":"2022-10-19T21:11:57","date_gmt":"2022-10-19T21:11:57","guid":{"rendered":"https:\/\/www.lighthousetest.com\/zh\/?post_type=knowledge-center&p=8198"},"modified":"2022-10-21T16:53:36","modified_gmt":"2022-10-21T16:53:36","slug":"gmp-annex-1-2022-update-breakdown-part-1-629","status":"publish","type":"knowledge-center","link":"https:\/\/www.golighthouse.com\/zh\/blog\/gmp-annex-1-2022-update-breakdown-part-1-629\/","title":{"rendered":"GMP Annex 1 2022 Update Breakdown: Part 1"},"content":{"rendered":"\t\t
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The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, was originally published as a draft in 2017. This draft<\/a> left many people operating in the pharmaceutical industry wondering at some of the proposed changes to the regulations that seemed to lack details and completeness.<\/p>

Now, GMP Annex 1 has been published with explanations to fill the gaps. This update is expected to not just change the EU\u2019s guidelines, but also the US FDA\u2019s regulations. We should expect to see the ramifications of this update throughout the world. This new update came out on the 25th of August 2022.<\/p>

The major changes in Annex 1 revolve around an infrastructural approach to Quality Risk Management (QRM) through a detailed and extensive Contamination Control Strategy (CCS). We see this in heightened restrictions around movement between clean zones, personnel presence, and documentation requirements. In general, this will require extensive – and potentially expensive – adjustments for operations using older equipment that won\u2019t be able to keep up with the new guidelines.<\/p>

In this blog post, we\u2019ll break down the first 5 parts of Annex 1\u2019s 10 sections. We will offer a brief overview of each section to provide a basic understanding of the new regulations. In part 2, we\u2019ll cover the remaining 5 parts.<\/p>

GMP Annex 1 Part 1<\/strong><\/h2>

Part 1 defines the scope and intent of the document. Annex 1 is designed to address the \u201cdesign and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM)\u201d. The authors do note that, while this was written for the purpose of setting standards for sterile products, there are sections which are simply good practices for any cleanroom.<\/p>

GMP Annex 1 Part 2<\/strong><\/h2>

Part 2 is titled \u201cPrinciple\u201d and discusses the foundation of the ideology behind Annex 1. Essentially: sterile goods should be produced in an environment designed for sterility by a highly trained staff using conscious, traceable processes.<\/p>

While simple in theory, this portion is where we start to see the new theme of Annex 1: automation to avoid contamination wherever possible, including removing personnel from the manufacturing line.\u00a0<\/p>

Humans are a major source of contamination in cleanrooms – that does not come as a surprise. So it makes sense to rely more heavily on machines and automation, but with those technological advances comes more regulations and guidances surrounding documentation, validation, safety, data integrity, and traceability.<\/p>

GMP Annex 1 Part 3<\/strong><\/h2>

Part 3 dives into the Pharmaceutical Quality System (PQS). It outlines the foundations of a good PQS:<\/p>