Quality Systems

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.

In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.

Could greater market transparency improve pharmaceutical quality and regulatory compliance?

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.

What’s ahead for the healthcare and pharmaceutical industries?

The new facility will focus on formulation development, drug product analytical development, and quality control.

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

Reliable, high-quality products require innovative analytics and production.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

Covert and layered approaches to combat drug counterfeiting and illegal diversion strive to stay ahead of criminal enterprises.

Governments stretch limited resources to track counterfeit, diverted, and stolen pharmaceuticals globally. \

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.