Quality Systems

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.

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

Intertek seeks to bring cost efficiencies to the pharmaceutical supply chain through confidential shared audits.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

BIO and PhRMA issued statements expressing the groups’ approval of the continuation of user fee programs.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

The company is voluntarily recalling Sten Z and M1 Alpha capsules because the product contains derivatives of anabolic steroids, which makes them unapproved drugs.

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.