Aesica, an Italian pharmaceutical contract development and manufacturing organization (CDMO), announced in a press release that it has begun producing serialized drugs for one of its partners. Implementation of the dedicated packaging line and serialization service at Aesica’s Pianezz site took about six months to complete.
Paolo Pizzorni, Senior Director at Aesica Pianezza said, “For our customer this means improved patient safety with a reduced risk of competition from counterfeit products and the ability to detect expired drugs automatically. The end-users are now able to verify the integrity and authenticity of the products dispensed to patients using a simple scan.”
Production for two anti-allergy drugs for marketing in China has begun. Western pharmaceutical companies see overseas countries like China as a key market. Serialization services allow companies to comply with China’s Ministry of Health Food and Drug Administration regulations.
Aesica at Pianezza is one of the first Italian CDMO companies to successfully serialize a pharmaceutical product. The factory uses digital processes to produce and check barcodes, not only for regulatory purposes, but to satisfy the client company’s internal tracking needs. Codes are in compliance with international ISO 15416 standards. Aesica’s platform includes thermal ink jet printers and thermal transfer technology that prints e-codes and 2D bar codes. The company has a variety of inks and flexible programming to comply with environmental standards and regulatory requirements.
FDA and State Action
The Food and Drug Administration (FDA) and state governments have long been interested in serialization as part of a drug’s pedigree. At an FDA workshop in 2006, a Massachusetts Institute of Technology (MIT) investigator suggested that serialization uniquely identify each item, each case, and each pallet with a one-time-use number at all levels, and that it be effective for at least 100 years. The State of California issued a message to the FDA stating that drug pedigrees have been 20 years in the making at the federal level and more than 7 years in California, and that the state prefers a deadline for 2015-17 for manufacturers, wholesalers, and pharmacies to serialize drugs.
Many states do have laws regarding serialization but rules are inconsistent, which makes it difficult for pharmaceutical companies and CDMO’s to follow. In November of 2013, the new Drug Quality and Security Act overruled state laws with national standards to track drugs.