Mail Order Pharmacy

Mail Service Pharmacy Compliance with Good Manufacturing Practices (GMPs)

IndustryMail Order Pharmacy
ProblemA mail service pharmacy needed to prove compliance with Good Manufacturing Practice (GMP) regulations for finished pharmaceutical products to successfully obtain a Patient Assistance Program (PAP) contract from a pharmaceutical manufacturer. The pharmacy also needed to update their policies and procedures to comply with the manufacturer’s specifications for drug storage, safety, and distribution.
PHSI SolutionPHSI performed a GAP analysis and evaluated the pharmacy’s current policies and procedures with GMP and the manufacturer requirements. PHSI identified all issues that needed to be addressed and assisted with updating the policies and procedures. During an onsite visit, PHSI toured the facility and noted any areas that could prove problematic in passing a GMP audit. PHSI then designed and administered a mock-audit for the pharmacy staff in advance of the actual audit. Issues identified were in advance of the manufacturer’s audit. Finally, PHSI conducted GMP training sessions for all pharmacy staff.
ResultsWith PHSI’s help, the mail service pharmacy responded to all issues in the audit report, which were minor in nature. The mail service pharmacy confidently and successfully passed the audit and obtained the Patient Assistance Program (PAP) contract from the pharmaceutical manufacturer.