Regulatory/GMP Compliance

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

The agency cited the Italian company for aseptic processing failures.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.

Optimize practices and meet requirements using electronic data integrity systems.  

The directorate highlights its 2016 achievements.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

This article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

As more companies decouple drug substance from finished drug manufacturing operations, an integrated approach can ensure safe, reliable logistics for frozen storage and shipping.

How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

New study will reveal bio/pharma practices and performance on quality issues.

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics