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References

V1.0, April 2013
  1. Australian Code of Good Manufacturing Practice – Human Blood and Tissues. 2000. TGA.
  2. Australian Code of good Manufacturing Practice for Medicinal Products, 2002
  3. Guide to the preparation, use and quality assurance of blood components. 14th ed, 2008. Council of Europe
  4. Recommendations on Validation Master Plan, Installation and Operation Qualification, Non-Sterile Process Validation, Cleaning Validation. PI 006-2, 1 July 2004. PIC/S.
  5. Guide to Good Manufacturing Practice for Medicinal Products. PE 009-5, 1 August 2006. PIC/S.
  6. Guide to Good Manufacturing Practice for Medicinal Products. PE 009-8 15 15 January, 2009. PIC/S

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