Quality Systems

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

The agency gives an update on the regulation of combination medical products.

FDA issued a warning letter to API manufacturer Unimark Remedies Ltd. for cGMP violations at its facility in India.

The European Medicines Agency plans on using existing patient registries to collect information on medicines.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.

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.