The European Union good manufacturing practices (EU GMP) guide which is being made effective from this month focuses on quality risk management and insists use of dedicated manufacturing units for specific products to avoid contamination. In its revised Chapters 3 and 5 related to premises, equipment & production compels the pharma industry to move to high quality level to stall non-conformity standards.

The new EU GMP guide is in sync with the latest developments where implementation of effective quality management system and operational excellence are mandated, noted pharma industry experts.

The revised Chapter 3 dealing with premises and equipment and Chapter 5 on production of the EU GMP Guide Part I for Medicinal Products for Human and Veterinary Use are now enforced and violations would be noted.

According to the regulator, the changes in Chapter 3 are actually easy to compare. The principles and the Chapters 3.1 - 3.5 and 3.7 - 3.27 are identical. Only Chapter 3.6 now mentions quality risk management for the risk control as well as requirements for the use of dedicated facilities. In addition there are indications on other paragraphs to be considered in Chapter 5 and in the Annexes 2-6. Further, a footnote also refers to the EMA Guideline on Shared Facilities.

In order to ensure that the pharma industry stays compliant to the new guidance, EU has provided an analysis where in a table format it presents a concise summary of the changes and compares the new document with that of the old.

The regulators sees that it would allow the pharma industry to quickly compare it with an existing quality management system and can be used for a GAP analysis which is a self inspection or for audits.

EU GMP Guide Part I, Chapter 5 focuses on Prevention of Cross Contamination in Production and in Chapter 5.17 it is supplemented with the inclusion of a norm on ‘Exception for the production of non-medicinal products with reference to Chapter 3. Further in the same chapter it grossly objects to the manufacture of non pharmaceuticals and has introduced ‘ Prohibition of production and storage of poisons, pesticides and herbicides.’

In Chapter 5.18, it has added regulations for genetic material, active pharmaceutical ingredients (APIs) and also omits mention of hormones and cytostatic drugs.

Under chapter 5.19, the focus is on Prevention of cross contamination through the design, with reference to Chapter 3). This is supported by the Chapter 5.20 referring to the EMA Guideline on Shared Facilities.

The guidelines also mandate supplier qualification not just for raw materials of pharmaceuticals but also selection, qualification, support of suppliers of primary and printed packaging materials. There is also a set of rules for rejected, recycled and returned materials.

Indian pharma industry sees that new EU GMP norms and the table which compares old versus new guideline enforced from early this month would ease of implementation.