Any feature must account for the mandatory authorization by the Spanish Agency for Medicines and Health Products (AEMPS) for any laboratory involved in manufacturing, importing, or exporting medicines.
An E-Signature & Batch Release Module that prevents the "Release" status of a product unless the designated Technical Director has digitally signed off on the batch record. 3. Good Manufacturing Practice (GMP) (Art. 18-20)
A Vendor Management System that cross-references API suppliers against the AEMPS Register and maintains records of supplier audits. 5. Foreign Trade & Investigational Products (Art. 29-38) real decreto 824/2010
While the title sounds dry ( regulating electrical sector procedures ), RD 824/2010 is famous — or infamous — for retroactively slashing feed-in tariffs for existing solar PV plants in Spain. It effectively cut guaranteed subsidies for hundreds of thousands of renewable installations that had been built under earlier, more generous rules (RD 661/2007 and RD 1578/2008).
An IMP Inventory Manager that separates experimental batches from commercial stock and handles specific labeling requirements for clinical trial materials. 6. Health & Safety for Staff Any feature must account for the mandatory authorization
Manufacturers of active pharmaceutical ingredients (APIs) must also be registered, and laboratories must verify the quality and origin of these substances.
: Regulating the import and export of medicines to prevent counterfeit products from entering the supply chain. Good Manufacturing Practice (GMP) (Art
The regulation requires laboratories to follow EU-harmonized Good Manufacturing Practices.
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