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Certifications

The quality of a final product quality depends on each quality measure taken during the manufacturing process. A philosophy of high quality is very important to us and e-Proteins has built a reputation of high quality products. A cGMP environment ensures this quality.
e-Proteins staff comprises highly experienced quality experts who ensure cGMP compliance and quality.

e-Proteins Quality Plan is reviewed regularly in terms of safety, efficiency, procedure and manufacture to ensure the highest quality for our clients. cGMP compliance certification is continuously reviewed and improvements implemented.

All batch records are analyzed online using a comprehensive set of control systems. Any deviation is analyzed and immediately corrected, and documented in a deviation report.

Infrastructure: e-Proteins operates in a class-D (ISO 8) clean room. This level of safety ensures top quality products for use by customers in parenteral applications.

GMP

  • e-Proteins operates in accordance with cGMP requirements, which ensure that the manufacturing process is clearly defined, controlled and repeatable.
  • Critical processes are validated as compliant and consistent with specifications and requirements.
  • Manufacturing processes are continuously controlled and recorded.
  • Instructions and procedures are written in clear and unambiguous language for the trained operators.
  • Deviations are investigated and documented via a change control procedure or deviation sheet.
  • A process control system is available for recalling any manufactured batch.

Drug Master File

A Drug Master File will be available in 2013. This document can be provided to all of our pharma customers using our products in parenteral applications.

  • (Guidelines Volume 3 : European Drug Master File Procedure for Active Substances, reference 3AQ7a)
  • Guideline on Active Substance Master File Procedure (ASMF) – EMEA/CVMP/134/02
  • Written within the CTD format
  • Applicant part (open part, available to the active substance end user)
  • Restricted part (only available to the authority)
  • Expert summaries