Quality Systems

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Pharmaceutical companies must see regulators as partners in their efforts to provide safe and effective therapies worldwide.

Pharmaceutical Technology reached out to the US Pharmacopeial Convention (USP) to get an understanding about how pharma manufacturers can get involved in developing industry standards.

Susanne Keitel, director of the European Directorate for the Quality of Medicines and Healthcare (EDQM), discusses the role industry plays in the development of pharmaceutical standards.

Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.

Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

FDA has revised its draft guidance to provide greater clarity and focus. This version would establish an initial voluntary phase to allow regulators and industry to focus, first, on a limited set of metrics.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

Domestic sales will be the key driver of revenue growth.

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Are investigations supporting or hindering performance excellence?

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.