Ikatan Sarjana Farmasi Indonesia

(ISFI) se - Indonesia
To

PT. Sanbe Farma

and
PT.Caprifarmindo Laboratories , Bandung

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 :

– In order to assure that the products manufactured always meet

its requirements , human resources competence are also our
main concern, therefore some experts from Multinational Coy
were recruited eg : GSK , Otsuka , Bexter , Schering AG .
 SSPP’s Manufacturing
facilities :
• State of the art in facilities and technologies
• In the process of applying GMP certification from PIC/S represented by
HSA Singapore , all findings have been closed out , estimated GMP
Certification will be rewarded on Q1 2008
• Mainly manufactures high volume of local and export products
• In line processes
• Closed system transferring technology
• Rooms condition is monitored and controlled by BAS ( Building
Automation System )
• Run 2 shifts production
• Committed to manufacture high quality products and commercially
efficient technology to be “ world class manufacturing company “
• Machineries are mainly equipped with PAT ( Process Automation
Technology )
• Shows growing volumes
• Further expansion is expected
GMP’s principles implemented at SSPP :
• Ensure that products are consistently manufactured and
controlled to meet specified quality standards
• Overall control is essentially carried out to ensure
consumers receive high quality products
• Strictly follows the concept of quality must be built into
the products , since It is not sufficient that finished
products pass testing only.
• Be Aware of The quality of products depend on the
quality of :
– Starting materials and packaging materials
– Production and quality control processes
– Building
– Equipments
– Personnel involved
Quality relationships :
Aspects of Management
Quality functions to define and
Management implement Quality policy

Systematic actions to apply

Quality policy in the shop
floor to ensure high quality
Quality Assurance products are always met

A dynamic system to
ensure products are
GMP consistently produced and
controlled

A Part of GMP that focuses

on testing of environment ,
Quality Control facilities , materials , finished
goods to comply with its
parameters/ specifications
Why is Risk Management so Important ?
• Increasing external requirements following significant failures - FDA, US
Sarbanes-Oxley, Turnbull Report.

• Experience within Factory of what happens when things go wrong

• Increased expectations of our shareholders, Customers, Regulators, Employees

of good corporate governance.

• Risk impacts to :
– Quality & Compliance
– EHS
– Business

US GMP Revision
"Pharmaceutical cGMPs for the 21st
Century:
A Risk-Based Approach"
Factory mission :

1. To secure source of supply

2. Compliance to regulatory and standards
3. Produce products to be best in class cost
1.To secure source of supply :

• Develop appropriate MRP…..life target April 2008

• Identify risk of supply , develop an alternative back up
for a single supplier
• Flexible production schedules to anticipate fluctuated
Demands
• Improve Forecast accuracy
• Develop a proper balance scored card/KPI’s to
improve performance of supply
2. Compliance to regulatory and standards :

• Establish internal audit level 1 and 2

• Regular GMP/EHS training program to shop floor
• Utilize advanced technology to control Quality
• Close supervision on IPC ( In Process Control )
• Implement Quality by Design concept from the
beginning process
• Strengthening QA Organization , assign Compliance’s role
•
3. Produce products to be best in class cost:

• Operational Excellence concept implementation in the

manufacturing organization
• Develop an efficient production and simplify process
• Strongly committed to be “World Class Manufacturing” Company ,
products are strongly competitive in the domestic and overseas
markets.
• Encourage to any new ideas for continuous
improvements
• Develop a bonus scheme for successful teams