Compendial Compliance

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

USP issues call for candidates for its 2015-2020 Council of Experts.

The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

Regulatory Authorities Discuss Elemental Impurities Standards

USP focuses on building worldwide partnerships in standards-setting activities.

USP appoints regulatory experts to elemental impurities implementation advisory group.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

The workshop will cover a proposed new method for measuring moisture vapor transmission rate.

USP has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network in China.

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

In the context of international trade, the need to develop global quality standards for medicines is increasing.

The Rostov-on-Don Medicines Quality Control Laboratory is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation.

The latest news from the pharmaceutical regulatory community.

The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

EMA announces collaboration with Israel, and USP updates chapter on elemental impurities.

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Overt and covert packaging technologies have evolved to authenticate drugs and fight counterfeits.

USP announces new drug naming policy and FDA releases two guidance documents.

USP revises labeling requirements for Heparin.

The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.

New US Pharmacopeial Convention standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.

New European Pharmacopoeia chapter aims to resolve problems with applying the harmonized UDU test to large sample sizes.

USP Hosts Symposium on Science and Standards

USP optimizes identification tests and impurities procedures.

Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.