Supply Chain/Logistics

With globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.

Challenges in Securing the Biopharma Supply Chain

Aesica Pharmaceuticals S.r.I. collaborates with QAD to meet China's Food and Drug Administration's shortened serialization deadline.

New identifiers and tracking requirements aim to block illegitimate products.

Vetter launches new serialization process to support track-and-trace efforts.

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

Thirteen companies are accepted for participation in the supply chain program.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

Almac releases an enhanced third-party logistics customer billing application.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

New FDA supply chain policies aim to strengthen inspection and oversight processes.

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

INTERPOL and 29 of the world's largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs.

A Q&A with SAFC and BioReliance about sourcing and risk mitigation for raw materials.

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

Manufacturers and regulators struggle to control phony versions of crucial medicines.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs in 2011.

European and US associations call for continued vigilance against the threat of counterfeit medicines.

The contract provider needs to know as much as the NDA holder.

The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain.

No matter the time or cost, knowing what's going on inside your facilities is always going to be worth the effort.

The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation. Since Annex 16 was introduced in 2001, a number of positive and negative trends have occurred in the pharmaceutical industry. In particular, confusion has arisen over the role of the qualified person (QP), and harmonization of requirements has been lost between member states. The EMA cites several commonly asked questions within the concept paper:

Incorporating regulatory requirements into the product life cycle is crucial.

Addressing supply-chain challenges.

Nigeria Looks to Simple Packaging Controls and International Cooperation to Curb Counterfeit Drugs

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

International outsourcing and rising theft spur regulatory action and manufacturer oversight.

The ability to deal with the complexity of the clinical supply process has shifted the balance of power to clinical supply chain specialists.