WHO defines Requirements on Zones E and F

In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.

http://www.gmp-compliance.org/enews_05367_WHO-defines-Requirements-on-Zones-E-and-F_15221,15231,15612,15266,Z-PEM_n.html

In May 2016, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. From a technical point of view, the guideline is very interesting and includes a detail which may be overlooked: it contains – as first international GMP guideline – a proposal for the definition of microbiological requirements concerning the zones E and F. So far, the approach to extend the zoning via the zones A-D defined in Annex 1 to the zones E and F and thus define microbial limits had only been available in an Aide Memoire of the ZLG (in German language). Now for the first time, this information is available in an international guide. As there are far less regulations in the area of non-sterile medicinal products than in sterile manufacturing, the proposal should be of great interest.

Access the draft Supplementary Guideline on GMPs for Heating, Ventilation and Air-Conditioning Systems for non-sterile Dosage Forms on the WHO webpage to find more detailed information. The deadline for comments ends on 12 July 2016.

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WHO issues revised Guideline on HVAC Systems

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry. Learn more about the revised guideline on HVAC systems.

http://www.gmp-compliance.org/enews_05358_WHO-issues-revised-Guideline-on-HVAC-Systems_15160,15221,15661,15612,Z-PEM_n.html

The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems used for the manufacture of non-sterile dosage forms. As most guidelines on this topic address the requirements for sterile forms, the previous version (TRS 961, Annex 1) from 2011 was gladly accepted by industry. Mentioned are non-sterile dosage forms as tablets, capsules, liquids or ointments, but also for the final steps in the manufacture of APIs. The WHO guideline means to provide guidance specifically for the areas design, installation, qualification and maintenance of ventilation systems. For the manufacture of highly potent materials the WHO refers to their Guideline TRS 961, Annex 3.

The biggest changes comprise:

• The chapter “Premises” was moved to the front to emphasize its importance. The chapter now further comprises some sample layouts
• The section “Commissioning, Qualification and Validation” was revised to match it with the  WHO Guideline TRS 937, Annex 4 (Supplementary guidelines on good manufacturing practices: validation)
• The part “Maintenance” was removed from the part “Commissioning, Qualification and Validation” and is now a separte chapter
• In addition a number of comments were added, graphs revised, and the overall readability was improved

Due to the many references and the numerous and improved illustrations the document is a good source for the (exemplary) requirements in the manufacture of solid and non-sterile dosage forms.

To find out more please visit the WHO website where you will find the draft document SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING SYSTEMS FOR NON-STERILE PHARMACEUTICAL DOSAGE FORMS. The deadline for comments is the 12 July 2016. The results are expected to be discussed during the 51st WHO expert committee meeting in October.

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WHO issues draft proposal for biosimilar naming

A long debate is ongoing about biosimilar naming around the world. Although EU accepted the same INN system years ago, with the latest developments around the world, biosimilar naming uncertainty is still ongoing.

The global INN (International Non-Proprietary Name) system is managed by the World Health Organization. They have held several meetings to solve this long debate and finally released a proposal for biosimilars naming.

WHO issues draft proposal for biosimilar naming: A long debate is ongoing about biosimilar naming around the world. Although EU accepted the same INN system years ago, with the latest developments around the world, biosimilar naming uncertainty is still… READ MORE

http://www.biosimilarnews.com/who-issues-draft-proposal-for-biosimilar-naming?utm_source=Biosimilar%20News%20%7C%20Newsletter&utm_campaign=0b76af10ab-15_08_2014_Biosimilar_News&utm_medium=email&utm_term=0_9887459b7e-0b76af10ab-335885197

New WHO Initiative “Good Pharmacopoeial Practices”

New WHO Initiative “Good Pharmacopoeial Practices”

A new WHO initiative is supposed to harmonise the pharmacopoeia standards, including the acceptance of the monographs between the single pharmacopoeias. To find out more about the WHO initiative “Good Pharmacopoeia Practices” please see the details.

http://www.gmp-compliance.org/ecanl_621_0_news_3772_7933_n.html

New WHO Initiative “Good Pharmacopoeial Practices”

The WHO started the new initiative “Good Pharmacopoeia Practices” with the goal to harmonise the procedures and the regulations for pharmaceutical standards. It is supposed to support authorities in ensuring the quality of pharmaceutical raw materials and finished products.The background for the initiative is that the retrospective harmonisation of pharmacopoeia requirements has proven to be difficult. A prospective harmonisation seems to be easier to accomplish. In the end the initiative is supposed to result in the harmonisation of pharmacopoeia standards.Representatives of all pharmacopoeias are involved in this activity. The WHO working document comprises an agenda with the planned activities. For instance, in June 2013 it was planned to discuss the feedback that was submitted with regard to the concept paper. For more detailed information please see the concept paper “Good Pharmacopoeia Practices“.