Beruflich Dokumente
Kultur Dokumente
(ISFI) se - Indonesia
To
Purwadi Dwijodarmanto
Manufacturing Director
17 January 2008
Milestone of Sanbe Sterile Preparation Plant
• November 2006
– SSPP has been officially opened for operation by Indonesian
Minister of Health in November 2006
– Already recorded to meet European Pharmacopoeia
– The Site is really a state of the art in facilities and technology
– Known as the first Pharmaceutical Company in Asia who is able
to sterilize Infusion products at 121 dC.
– Some overseas consultants on the projects were recruited
– USA Kinetic turnkey project completed
– Scada automatic control system in place and in use, pre audit
carried out by a consultant from PharmOut Australia was
completed,
– The company has 5 pilars as the key success factor : people ,
advanced technology on facilities and equipment, System and
Procedures / QMS, documentations and commitment to
implement GMP Strictly in the shopfloor
– The Sites have exported products to some countries
Milestone of Sanbe Sterile
Preparation Plant
• Toll Manufacturing
– Just recently in this month , a toll manufacturing agreement between
NVOrganon and PT.Sanbe Farma has been signed of, where NV
Organon has appointed SSPP to be a contractor to manufacture NV
Organon’s sterile products in the near future.
• Human resources :
A dynamic system to
ensure products are
GMP consistently produced and
controlled
• Risk impacts to :
– Quality & Compliance
– EHS
– Business
US GMP Revision
"Pharmaceutical cGMPs for the 21st
Century:
A Risk-Based Approach"
Factory mission :