Regulatory/GMP Compliance

CDER withdraws some outdated guidance documents and makes plans to finalize others.

The guidance describes a risk-based approach to monitoring of clinical trials.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

FDA issues draft guidance to minimize medication errors.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

Prefilled-syringe line features automation and novel disinfection techniques.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

Draft guidance combines and supersedes previous guidance documents.

FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year.

Keith Bader, senior director of technology at Hyde Engineering + Consulting discusses his presentation ?Establishing a design space: cleaning process development and validation,? which will be presented at Interphex 2013

Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held at Interphex 2013

The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.

FDA's requirements for API manufacturers in regards to ICH Q7.

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

FDA has released a list of more than 50 guidance documents planned for 2013.

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.

A thorough investigation of all possible causes of deviations should be performed.

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products.

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

Eli Lilly expects overall revenue growth in the coming year.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.

Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.