Turnkey Project Management

POLIFARMA KEY FIGURES

  • Site in TURKEY since 1992.
  • GMP Production for IV Solution Products and Medical Devices.
  • 4 International customers with more than 60 different products.
  • More than 120 million units /year.
  • Manufacturing License for IV Solution Products Certified to ISO 9001, ISO 13485, ISO 14001, OHSAS 18001.
  • Successful JFDA audits in 2014.
  • Other regulatory approvals e.g. Iraq, Libya, Kosova, Azerbaijan
  • in Vacuumed Glass Bottle

AVAILABLE SERVICES

  • Project management and coordination.
  • Risk analysis workshop with the customer’s team.
  • Feasibility, technical and development runs.
  • Drawing Layouts, Personnel and Material Movement.
  • Restricted Area and Clean Room Construction.
  • Preparation of URS (User Requirements Specıfıcatıon) document and offers for main equipments.
  • Support during FAT (Factory Acceptance Test) and SAT. (Site Acceptance Test)
  • Upgrades and modernisation of existing machines.
  • Preparation of qualification and validation documentation in compliance with FDA, EU-GMP or WHO Guidelines .
  • Support of the qualification and validation.
  • Support of Pilot & Scale-up batches.
  • Support of Stability Studies, Registration.
  • Support of the pharmaceutical production.
  • Writing of SOPs.
  • Writing of SMF. (site master file) according to PIC/S (The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)
  • Technical consulting.
  • Training, on-site customer training.
  • Preparation of URS (User Requirements Specıfıcatıon) document and offers for laboratory equipments.
  • Support of laboratory setup.
  • Support of analitical method validation.
  • All services not only for pharmaceutical production, but also for all utilities in the pharmaceutical field. (e.g. clean room, HVAC, water treatment, pure steam, secondary packaging, autoclaves, etc.)

POLIFARMA VALIDATION AND QUALIFICATION SERVICES


Qualification Steps:

1- Validation Master Plan
2- Risk Analysis
3- Desing Qualifiication
4- Insatallation Qualifiication
5- Operational Qualification
6- Performance Qualification
7- Support during Process Validation

1- Installation qualification

  • Site in TURKEY since 1992.
  • GMP Production for IV Solution Products and Medical Devices.
  • 4 International customers with more than 60 different products.
  • More than 120 million units /year.
  • Manufacturing License for IV Solution Products Certified to ISO 9001, ISO 13485, ISO 14001, OHSAS 18001.
  • Successful JFDA audits in 2014.
  • Other regulatory approvals e.g. Iraq, Libya, Kosova, Azerbaijan
  • in Vacuumed Glass Bottle

2- Operational qualification

  • Functional check of the components
  • Valves, measuring equipment, etc.
  • Checking of the process steps
  • Documentation of the process parameters
  • Checking of the safety equipment
  • Checking of the control system

CIP validation

  • Planning of the validation
  • Creation of the sampling plan
  • Development of the cleaning procedure
  • Execution of the CIP (Clean in Place) validation
  • Evaluation of the validation results
  • Consulting for analytics

SIP validation

  • Planning of the validation
  • Determination of the coldest points
  • Execution of the SIP (Steam in Place) validation
  • Service for evaluation of the biological indicators
  • Evaluation of the validation results

Execution of customer training and on-site customer training

  • Hygiene/GMP

BENEFIT FROM THE SUPPLY OF POLIFARMA SERVICES

  • Experienced team of engineers already planned executed several projects and other pharmaceutical technology
  • Daily experience with pharmaceutical production gives us the know-how to work quickly and reliably
  • Specific knowledge for planning, qualification, validation and utilities
  • Minimised costs for customers due to existing experience, knowledge, documents
  • Close connection to customer, short reaction, exchange of ideas, joint projects
Do not hesitate to contact us : info@polifarma.com.tr