Our multinational client, a manufacturer of bulk Active Pharmaceutical Ingredients, made a strategic decision to migrate to a new electronic system. From their Warehouse perspective, this change would result in the current Sales Picklist Process being out of compliance with Quality Standard ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients. The process also did not fit with the standard process within the new electronic system and customisation was too expensive. Crystal Lean Solutions were invited to lead the Redesign Project in conjunction with the Warehouse team members over a 4-month period. The key objectives of the project included:
Using the DMAVD methodology, CLS first reviewed the current process with warehouse personnel, mapping the actual workflow and paperwork trail. Key steps under review included a) identifying customer requirements b) selecting appropriate materials c) labelling drums and d) supply of paperwork. The number of entries were counted, including both entries and reviews required. From reviewing the data and identifying unnecessary activities, the following changes were implemented, which complied with ICH Q7:
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