Quality Systems

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

On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

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.

Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.

Research suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.

TraceLink’s Graham Clark, director of contract supplier relationships and cofounder, and Brian Daleiden, vice-president of industry marketing, shared insights into industry’s serialization readiness as well as recent trends and developments with Pharmaceutical Technology.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).

The agency is asking public consultation on the concept paper.

Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.