Regulatory/GMP Compliance

Process validation is an extension of biologics development processes.

Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.

A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.

The agency published guidance on the research and development of individualized therapies.

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.

The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.

Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

FDA published guidance on the format and content of REMS documents.

The agency published four guidance documents regarding ANDAs and amendments to ANDAs.

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.