The present technical interpretation of Annex 1 to the PICS GMP Guide PE.Principle General principles as applied to the manufacture of sterile products. Scope Includes additional areas (other than sterile products) where the general principles of the annex can be applied. 1 1 Annex 1 : Manufacture of Sterile Products 2 3 Document map Section Number General overview 1.Proposed date for release of draft guideline is October 2015.
The original version was partially revised in 1996, 20. This webinar will outline a holistic approach to ensure continued compliance, taking into account the expected changes, including the need for EM.
