Production OTC
We manufacture and package OTC products for the United States and Canada in compliance with pharmaceutical standards (21 CFR part 210/211 ; Guidelines on Good Manufacturing Practices published by Health Canada)
– Manufacturing and packaging of OTC pilot batches
– Stability study according to ICH Q1
– Manufacturing and packaging of OTC industrial batches
– Writing of master production files (Master Batch Records)
– Qualification of equipment used for OTC (QI / QO / QP)
– Validation of analysis methods according to ICH Q2
– Process validation