Inside Standards

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

Regulators and industry leaders take on the task of securing the drug supply chain.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

USP evaluates quality attributes for synthetic peptides.

PDA works with FDA to create pharmaceutical quality metrics.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

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

USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.

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

This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.

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

Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.

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

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.

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

USP optimizes identification tests and impurities procedures.

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

ICH Q8, Q9, and Q10 support and implications for the future.

To keep moving forward, the Pharmacopoeial Discussion Group needs industry participation.

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

Europe establishes new collaborative system to track products.

Expanding the organization's mandate will strengthen inspections.

A summary of the latest steering committee and expert working groups' meeting.

USP promotes horizontal standards for biologics' quality attributes.

Why SOPs are rarely followed, often cited, and in need of follow-through.

Monograph modernization and standards donation go hand in hand.

A review of current efforts within PDA's Paradigm Change in Manufacturing Operations initiative.