Be assured that products intended for human or animal use are manufactured consistently, in a controlled manner, and are replicable, ensuring the products' efficacy, safety, and quality.
With you on your biologics journey...
Why GMP manufacturing?
Good Manufacturing Practice (GMP) methods assure that products intended for human or animal use are manufactured consistently, in a controlled manner, and are replicable, ensuring the products’ efficacy, safety, and quality.
3P´s GMP manufacturing services
All cGMP material produced by 3P is manufactured according to applicable EMA, ICH or FDA cGMP guidelines. Our Quality Control department tests all Drug Substance using the analytical methods defined in earlier stages. It is then released according to the product specification by our Quality Assurance team. Each batch is accompanied by a Certificate of Analysis (CoA) and a Certificate of GMP compliance.
What we will deliver?
3P delivers efficient and reliable cGMP batches supported by all relevant clinical study or commercial product supply documentation.