GDP Pharma Wholesaling & Warehousing IMS Toolkit

Distributors, wholesalers and warehouse operators sit between the manufacturer and the patient, and this Integrated Management System is written for that position. It embeds Good Distribution Practice as set out in WHO TRS 957 and the EU GDP Guidelines alongside ISO 9001 quality management and ISO 22301 business continuity, under an IMS manual, documentation and process interaction schemes, and one integrated quality, GDP and business continuity policy.

Procedures follow stock through the site: supplier and customer qualification, purchasing and incoming goods receipt, warehousing storage and temperature control, picking, packing, dispatch and transportation, returns, complaints, recalls and falsified medicines, deviation and CAPA, and change control. The record set is the part an auditor asks to see — temperature and humidity monitoring logs, temperature excursion reports, goods receipt and incoming inspection records, dispatch notes and transport records, returns assessments and customer complaint reports, alongside registers of legal and regulatory requirements and of approved suppliers and customers. Checklists turn GDP chapters into daily and weekly warehouse rounds, transport and dispatch checks and a readiness gap analysis, while continuity documents run from business impact analysis and RTO, RPO and MTPD through to exercised incident response plans.