The
following new PIC/S Guidance documents have been adopted:
PIC/S
Aide-Memoire on “CrossContamination in Shared Facilities” (PI 043- 1).
PIC/S
Guidelines on the formalised risk assessment for ascertaining the appropriate GMP
for excipients of medicinal products for human use (PI 045-1).
PIC/S
Guideline on setting health-based exposure limits for use in risk
identification in the manufacture of different medicinal products in shared
facilities (PI 046-1).
PIC/S
Guidelines on the principles of GDP for active substances for medicinal
products for human use (PI 047-1).
Also,
the following Chapters and Annex of the PIC/S GMP Guide have been revised:
- Chapter 3 on “Premises and Equipment”;
- Chapter 5 on “Production”;
- Chapter 8 on “Complaints and Product Recall”;
- Annex 17 on “Real Time Release Testing and Parametric Release”.
- The revised Chapters are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language.
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