Regulatory/GMP Compliance

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

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

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

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

The agency published guidance on data integrity as it is relates to CGMP compliance.

The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.

The agency issues safety guidance to minimize medication errors relating to product design and container closure design.

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.

The report examines the increased number of companies cited by regulators for data integrity issues.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.

Data integrity is a widespread, global problem that must be addressed.

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

Regular removal of residues from disinfectants and sporicidals is important for improved aesthetics and safety in cleanrooms.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

The author reviews FDA's final Animal Rule guidance.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.