FDA-COMPLIANT SOP TEMPLATES for Pharmaceutical Logistics

English

Stop building procedures from scratch. This package includes 7 complete and editable SOPs, developed based on 21 CFR, FDA guidance, USP and DEA — ready to adapt and implement.

7 SOPs included:

• Warehouse Temperature Control and Monitoring

• Temperature Excursion Management in Transportation

• Returned Product Verification (DSCSA Saleable Returns)

• Schedule II Controlled Substance Handling

• Identification and Management of Logistics Deviations

• Receiving and Responding to FDA Inspections

• Importation of Drugs and Dietary Supplements into the USA

Who it’s for:

→ Wholesale distributors and 3PL operators

→ Pharmacists and QA managers

→ Regulatory consultants and compliance auditors

→ Companies seeking FDA compliance in the USA

Supplement to the eBook “FDA Compliance in Pharmaceutical Logistics”.

Show more