Services
Validation Support.
Our validation team has extensive practical know-how on
regulatory requirements (FDA/EMEA) and several local
regulations. Commissioning and Qualification are performed at
the vendor workshop and in Pharmadule's production facilities,
resulting in a faster Commissioning and Qualification and final
approval of the plant.
The work is performed according to a Commissioning Master
Plan and a Qualification Master Plan. We work according to the
current Good Manufacturing Practices (cGMP) for facility design,
record keeping, personnel qualifications, sanitation, cleanliness,
IQ (Installation Qualification), OQ (Operational Qualification),
and complaint handling. The client performs the process and
cleaning validation. Support is provided if needed.