Annex 1 Chapter 6 and its Comparison to Compendial Mandates: What Does It Imply to the Industry

Instructor: Nissan Cohen
Product ID: 706362
Training Level: Basic to Intermediate
  • Duration: 60 Min
Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.

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Last Recorded Date: Feb-2020

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Why Should You Attend:

Annex 1 is technically written for Sterile Product manufacturing. However, enforcement includes critical utilities and pharmaceutical water systems. It is imperative to understand how Annex 1 may influence your products’ manufacturing, documentation, processes, and production.

Without the knowledge of how Annex 1 may influence your operations, the resulting knowledge gap could cause European regulatory problems. All manufacturers of pharmaceutical products sold or marketed in the European Union as susceptible to European regulatory audits.

Although Pharmaceutical manufacturing is a global industry, understanding the regional or local mandates is imperative to ensure regulatory compliance. You will understand and learn how to ensure your compliance to the compendial and mandated regulatory enforcements regarding all classifications of pharmaceutical water. Are you prepared to tackle the Annex 1 mandate?

The adoption of Annex 1 may cause difficulty in compliance for European and global manufacturers whose products are marketed in the European market. You will understand how to navigate the tightrope between foreign regulatory needs and fulfilling you domestic regulatory needs. Additionally, this presentation will identify the regulatory players for composition and enforcement of this mandate. We will identify the pharmacopeial mandates and the conflicts of Annex 1’s adoption in its current proposed revision.

Although Pharmaceutical manufacturing is a global industry, understanding the regional or local mandates is imperative to ensure regulatory compliance. You will understand and learn how to ensure your compliance to the compendial and mandated regulatory enforcements.

Areas Covered in the Webinar:

  • Annex 1 review of current proposed revision 2019
  • Comparison to Annex 1 2008
  • Identification of European and International regulatory agencies involved with Annex 1
  • Discussion on individual country regulatory enforcement outside of EU
  • Comparison of Annex 1 to European Pharmacopeia (Eur. Ph.)
  • Comparison of Annex 1 to United States Pharmacopeia
  • Conflicts and discrepancies identification between Annex 1 and Pharmacopeias
  • How to ensure your pharmaceutical water systems will comply with Annex 1

Who Will Benefit:

Pharmaceutical personnel in:

  • Engineering, water systems, critical utilities, QA/QC, operations, production, maintenance, And Engineering management

From the Biopharmaceuticals Industry

Instructor Profile:
Nissan Cohen

Nissan Cohen
Owner, Biopharmaceutical Water Doc

A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology.

Co-Chairman, Contributing author and Chapter Leader of International Society for Pharmaceutical Engineering’s (ISPE) “Baseline Guide for Pharmaceutical Water and Steam Systems”. Revisions 1, 2, and 3

Co-chairman and Coordinating Author of the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.

Contributing author to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide on Ozone. Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine.

Follow us :
Raw Material Requirements
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

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