It added that weighing is both one of the most common and the most critical tasks in a lab, since the smallest error can pervade the whole analysis, affecting the accuracy of reported results.
Eur., “fills a long-standing gap by setting out clear requirements for a piece of equipment that is the cornerstone of every analytical procedure described in the Ph. Eur.”. The new addition was adopted at the Commission’s 168 th session in November 2020 and, according to Ph. The Committee of Ministers also has adopted a resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies as the US FDA looks to crack down on such compounding pharmacies, which produced drugs that led to numerous deaths in the US.The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter, Balances for analytical purposes (2.1.7), included in Supplement 10.6 of the Ph. Eur., published in July 2021. In addition to the South Africa announcement, the EDQM (European Directorate for the Quality of Medicines & HealthCare), which supports the EU Pharmacopeia, announced Monday that it would craft a draft resolution aiming to harmonize the quality and safety standards around the production of pharmaceuticals in pharmacies.įollowing a survey in 2008 by the Committee of Experts on Quality and Safety Standards for Pharmaceutical Practices and Pharmaceutical Care, the EDQM found “a wide gap” in quality assurance and standards for pharmacy-made medicinal products between EU countries, as well as a gap in quality assurance between preparation in pharmacies and medicines prepared by the pharmaceutical industry. The standards are official for all 37 member states and the EU. The eighth edition of the European Pharmacopeia includes more than 2220 monographs and 340 general chapters on the specifications for active substances and excipients used in medicines. The council, unlike a number of regulators in neighboring African countries, has made a push in recent years towards more transparency by seeking industry comment on new regulations and guidance, as well as keeping its website up to date.Īlthough observer states to the European Pharmacopeia are not required to institute the monographs or chapters, some, such as Canada and Australia, have done so in the past. The Medicines Control Council of South Africa - which joins Morrocco, Tunisia, Guinea, Senegal and Algeria among its African counterparts, and 20 other observers, including the World Health Organization – will now be able to attend the pharmacopeia commission’s sessions. Tabletting, coating & ancillary equipment.
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