Define each activity precisely
GDP addresses distribution, while GMP addresses manufacturing. Filling, packaging, repacking and labelling can fall within manufacturing regulation. Describe each process step before selecting premises. A general description such as contract packaging is insufficient for regulatory classification.
Develop premises requirements from the process
Products, processes and risks determine personnel and material flows, segregation, cleaning and utilities. Pharmaceutical activities do not all require the same cleanroom class. Sterile manufacturing has additional requirements. EudraLex Volume 4 and applicable annexes provide the relevant framework.
Qualification and ongoing controls
Specify and qualify premises, equipment and critical utilities for their intended use. Process and cleaning validation, environmental monitoring and controlled changes may be required. A written user requirement specification helps distinguish existing building features from later operator responsibilities.
Connect manufacturing with warehousing
Raw materials, packaging, intermediates and released finished products need traceable status control. Plan production and storage together while preserving separate approvals. A manufacturing Qualified Person responsible for batch certification performs a different role from the wholesale responsible person.
Prepare for site planning
The planning lists below are practical recommendations for your site project; they do not replace project-specific qualification or a regulatory decision.
- Describe products and every process step
- Determine GDP, GMP and authorisation scope
- Specify flows, premises, equipment and utilities
- Identify qualification and validation needs
- Assign releases and manufacturing-storage interfaces