Compendial Compliance

The author discusses how to manage pending pharmacopeial changes.

FDA promotes supply chain pilot program. EMA opens pharmacovigilance legistation up for public consultation. USP Calls for Somatropin Cell-Based Bioidentity Method.

How FDA, USP, and ICH have redirected industry practice.

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."

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

Does global development have to entail multiple comparability studies?

The US Pharmacopeia has issued a third round of improvements to its blood thinner standard.

Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.

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

EMA Releases Genetic Variability Guideline.

FDA Addresses the Regulation and Approval Process of PET Drugs.

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

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

The US Pharmacopeia (USP) proposes to lower the maximum permissible limits of trace elements in pharmaceuticals and recommends that impurities be measured through automated instrumentation-based methods. The proposed regulations specify inductively coupled plasma–mass spectrometry (ICP–MS) and inductively coupled plasma–optical emission spectrometry (ICP–OES) as the techniques of choice. This article discusses the benefits of ICP–MS and ICP–OES for the accurate detection of trace elements in pharmaceutical products, in compliance with the proposed USP chapters.

Europe establishes new collaborative system to track products.

The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.

Might European officials reverse their position on acceptable production methods?

After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

By providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.

USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.

USP promotes horizontal standards for biologics' quality attributes.

Ensuring compliance though increased statistical knowledge and resources.

How do you assign a minimum sample weight for a US Pharmacopeia <41> balance application when the tested repeatability gives a standard deviation of zero?

Regulators and standard-setting bodies are re-examining over-the-counter drugs.

Monograph modernization and standards donation go hand in hand.

Regulators question whether particles that they can't see hurt patients.

Bob Weaver, president of HunterLab, discusses current trends and challenges.

Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.