Quality Systems

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

Dual sourcing is one of many possible solutions to securing the supply chain.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses the requirements for good distribution practices.

Sponsor response to FDA's breakthrough program has exceeded FDA expectations, but puts pressure on manufacturers to address formulation, stability and quality production issues very early in development.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

USP and ChP jointly host two-day meeting to strengthen cooperation.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

The agency cites deviations from CGMPs for the manufacture of APIs at the company?s Gujarat, India plant.

USP releases compendium of quality standards for compounded medicines.

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

The European Medicines Agency responds to the European Ombudsman?s letter regarding redacted documents.

FDA releases guidance specifying its preferred unique facility identifier system.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.