Regulatory/GMP Compliance

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

The Chinese facility was cited for data integrity violations.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

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The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.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