Concept of Compliance
Quality Assurance
  • Implementation of the quality policies of Jasun Pharmchem regarding ISO 9001:2000 and ISO 14001 regulations as well as internal quality requirements.
  • Assessment and approval of master batch records, testing methods and specifications.
  • Assessment and approval of their change control procedures.
  • Registration and assessment of investigation reports about raw material and internal complaints, deviations from analytical procedures and process deviations.
  • Scrutiny of the complete batch documentation.
  • Release of Jasun's products.
  • Treatment of quality related customer inquiries and investigation of customer complaints.
  • Supervision of the current product quality through the preparation of the Annual Product Reviews and Product Quality Reviews.
  • Supervision of the organisation regarding the advisability and the improvement of quality.
  • Supervision of qualification and validation activities.
  
Validation and Qualification
  • Equipment qualification
  • Process validation
  • Cleaning validation
  • Computer system validation
  
Quality Control
  • Testing of intermediates, raw materials and packaging materials.
  • Chromatography (HPLC and GC), spectroscopy, titration and wet chemistry.
  • Method transfers and validation, process validation samples, purity profiles and stability testing of final products and intermediates.
  
Quality Management
  • Contracts
    - Describe responsibilities of quality, regulatory and production personnel.
    - Guarantee consistently high performance of all our products.
  • GMP Training
    - Organized and performed by the Quality Management department.
    - Internal courses to maintain a high level of GMP awareness.
  • Internal/External audits
    - Monitor the implementation and respect of cGMP within Jasun.
    - Ensure that requirements are met by vendors and subcontractors.
  • Inspections/Customer audits
    - Verification of compliance by regulatory authorities.
    - About 10 customer audits per year for evaluation purposes.
  • Document Management/Archiving
    - Documentation system according to ISO 9001:2000 requirement.