Quality Systems

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

Managing change and overcoming employee resistance and fear requires a proactive approach.

An integrated approach can improve the efficiency of cleaning validation studies.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

Hedley Rees, managing director at PharmaFlow Ltd and a member of the CPhI expert panel, shares his views on pharmaceutical supply chain issues.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

US Compounding, Inc. issues voluntary recall of all sterile products.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

ReposiTrak signs agreement to pilot track and trace system in pharma.

Exports and domestic market have each been valued at more than US$15 billion.

The company is keen to show how new packaging technologies can incorporate patient-focused elements.

CPhI expert, Girish Malhotra, warns that without urgent regulatory reform, the industry would remain reluctant to make process changes that will improve manufacturing efficiency due to the financial and time constraints of re-approval.

Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

EDQM clarifies elemental impurities guidelines for veterinary and other products.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

Manufacturers challenge details in new policies designed to promote access to important therapies.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

FDA publishes the final Q3D Elemental Impurities guidance.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?