Quality Systems

The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.

The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

The agency published guidance on identifying trading partners under DSCSA.

FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.

The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.