Regulatory/GMP Compliance

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

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

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

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

A Q&A with FDA to gain insight on FDA's views of three-dimensional printing and its regulation in drug manufacturing.

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

Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.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

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

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.

Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.

Early planning for the integration of clean-in-place systems for equipment cleaning is key.

China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.

Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.

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

The agency provides quality, development, manufacturing, and labeling recommendations.

Computerized systems can solve some of the data integrity problems with conventional paper-based systems.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

The agency publishes three final guidance documents on drug compounding.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

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

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

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

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

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.