Regulatory/GMP Compliance

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

FDA and industry seek speedy Congressional approval of new user fee plan.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

The author provides a review of the concepts of design and qualification that apply to single-use systems.

A streamlined approach may enhance process efficiency and product quality.

Agency guidance and industry standards aim to reduce lapses and improve quality operations.

ICH detailed the highlights of the council’s June 2016 meeting.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.

An understanding of continuous process validation can lead the way to consistent approaches, reduced investigation times and observations, the avoidance of lost batches, and high-quality products.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

Biomedical innovation legislation may stall in 2016.

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.