The recently released version of the European Pharmacopoeia explores its importance to pharma manufacturers worldwide.
FREMONT, CA: Drug manufacturers supplying the EU market must follow the European Pharmacopoeia, which is a significant guide to the quality standards. The most recent publication of the guidance paper, released in July 2021, includes a new chapter on analytical balancing specifications. In this, SelectScience examines the background and significant problems, talking with Sartorius' leading specialists about the consequences of this update for manufacturers and how an optimized lab balance design can assist with pharmacopoeia compliance. Pharmacopoeias are drug specification documents that are intended to unify and govern the formulations of various kinds of medicines. They describe the criteria for drug production as well as the procedure involved. Modern national and regional pharmacopoeias have been published as joint efforts since the early 19th century, however, some of the ancient known pharmacopoeias date back to before the 10th century.
Nowadays, pharmacopoeia standards are regulated in such a way that if a drug is sold in the United States market, the manufacturer must comply with the United States Pharmacopoeia (USP) stipulations, regardless of the origin country of drug production. For instance, this applies to global pharmaceutical corporations that manufacture drugs in countries such as India, where the US Food and Drug Administration (FDA) would still be the final decision maker on Indian-manufactured drugs entering the US market, based on compliance with the USP. Furthermore, the European, Chinese, Japanese, and other pharmacopoeias operating within their jurisdictions must adhere to similar rules.
If a pharmaceutical producer supplies to various markets around the world, its drug, and associated manufacturing process must follow the guidelines established in each of the applicable individual markets. Dr. Julian Haller, metrology specialist at Sartorius, states that even though differences between major market pharmacopoeias around the world, such as the USP and the European Pharmacopoeia (Ph.Eur. ), are minimal, yet they exist which makes it critical for manufacturers to strictly follow the details.