Scale-Up & Process Validation
NextPharma offers pharmaceutical formulation development and subsequent scale-up services to ensure safe routine production at commercial scale, including stability testing according to ICH-guidelines.
Batch sizes are adapted to meet customers' requirements. For each production step, qualified equipment is available in the relevant dimensions to support the processing across a range of batch sizes, providing customers with a consistent and reliable scale-up service.
Process validation, including complete documentation, is performed on the first product batches and according to customer requirements. Validation will qualify the manufacturing process in respect of product conformity with specifications.
At pilot and commercial scale, dedicated containment areas enable NextPharma to handle specific product types, including:
- Hormones (oral and topical)
- Steroids (oral and topical)
- Antibiotics (oral), including penicillins and cephalosporins
- Controlled drugs
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