Regulatory/GMP Compliance

The agency will require training for healthcare providers who prescribe immediate-release opioids.

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

The agency is looking for industry input on best practices for continuous manufacturing.

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

When it comes to getting the best out of quality by design, timing is everything.

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.

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

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

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.

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 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.

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

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.

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

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

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

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

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 cited the Italian company for aseptic processing failures.