Montreal, QC, March 22nd, 2018 – Today MEDISCA, the industry leader for providing high quality compounding solutions and services to pharmacists worldwide, issued a reinforcement of its stringent purchasing criteria for Active Pharmaceutical Ingredient (API) manufacturers. The criteria are in place to ensure high quality delivery of products to customers, providing peace of mind to pharmacists, physicians and the patients who depend on customized compounded medication.
“MEDISCA’s top priority when purchasing APIs is to ensure that we are not compromising quality for lower cost of material,” said Anna Di Nezza, Director of Quality. “We have established and continue to enforce rigorous criteria to eliminate the risk of jeopardizing the health and safety of patients who rely on customized medication to meet their specific needs. We continuously review the criteria and strengthen it as necessary.”
The criteria for sourcing and purchasing APIs include the following:
A complete review of the Manufacturer’s Certificate of Analysis against the latest edition of the product monographs: USP, EP, BP, etc.;
Full compendial testing including residual solvents conducted by MEDISCA to validate manufacturer testing results;
Manufacturers must be FDA registered and subject to regulatory inspections;
GMP evidence that the manufacturer produces APIs according to Good Manufacturing Practices;
Quality Agreement must be signed and agreed upon by both parties;
Review of stability studies to validate manufacturer’s expiration date.
MEDISCA’s commitment to quality has been recognized with several accreditations including VAWD, ISO9001:2015 and ISO 13485:2016. The company seeks to continuously increase the standard of quality of products and preparations. For more information on MEDISCA, please visit www.medisca.com.
MEDISCA is the leader in providing turnkey solutions to the pharmaceutical compounding industry and allied health care professionals worldwide. Through its global partners, LP3 Network and MEDISCA Network, MEDISCA is committed to being a complete resource for prescribers, pharmacists and pharmacy technicians engaged in personalized medicine by offering educational trainings, products, and support. Founded in 1989, the company has locations in Canada, the United States and Australia, optimizing its service to the international market. For more information about MEDISCA, please visit www.medisca.com and follow us on Twitter at @medisca.