Regulatory/GMP Compliance

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

New study will reveal bio/pharma practices and performance on quality issues.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.

The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.

Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.

Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

The agency cited the company’s India facility for batch failures and data integrity problems.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

Industry fears limited benefits as FDA readies voluntary data tracking program.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Continuous manufacturing will not work for all pharmaceuticals, but the right infrastructure, senior management support, and planning from the earliest stages of drug development could eventually allow up to 80-90% of small-molecule APIs to be made continuously, says Paul Sharratt, head of process science and modeling at Singapore’s Institute of Chemical and Engineering Sciences.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.

An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

The DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.