This technical alert, available here, contains important detail and analysis regarding the upcoming PIC/S GMP Code Version 14, and helps members understand the upcoming PIC/S GMP Code by summarising key areas where expectations are, and are not, changing for listed medicine manufacturers.
The alert includes:
-The implementation date of Version 14 and transition periods;
-Information on Gap Analysis relating to clarification of interpretation and effect on Listed Medicine Manufacturers;
-Expectations regarding audits of raw material manufacturers/suppliers;
-Oversight of outsources testing and contract laboratories; and
-increased clarity of processes which permit reduced end testing.
Also included is information on increased publication of ARTG information.