Quality Systems

The European agency presents guidelines for conducting post-authorization efficacy studies.

FDA noted multiple manufacturing, testing, and labeling violations at American Family Pharmacy’s Indianapolis facility.

New program emphasizes quality, risk, and global collaboration.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

The company is voluntarily recalling the epinephrine injection, USP because of potential inaccurate dosage delivery.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.

USP responds to FDA's draft guidance on the naming of biological products.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

EMD Millipore, the life-science division of Merck KGaA, has introduced Parteck SRP 80, a new functional excipient for oral sustained-release formulations. The excipient is polyvinyl alcohol (PVA)-based and fully synthetic-according to EMD Millipore, this feature ensures batch-to-batch and performance consistency and facilitates quality by design (QbD) and validation processes.

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

The agency provides terms and recommendations for packaging and labeling of injectable medical products.

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.