Example: confidence
Q4b annex 6
Found 2 free book(s)
ICH HARMONISED TRIPARTITE GUIDELINE
database.ich.orgThe draft Q4B annex is made available for regulatory consultation in the three regions (generally for 3 months). The regulatory consultation and discussion should focus on the Q4B Outcome in the annex. The Q4B EWG can revise the annex based on comments received and submits a final draft of the annex to the ICH Steering Committee.
Guidelines English Module 3 P part - moph
moph.gov.lbANNEX Q4B 4A(R1) Q4B ANNEX 4B(R1) Q4B ANNEX 4C(R1) Where appropriate, the microbiological attributes of the dosage form should be discussed, including, for example, the rationale for not performing microbial limits testing for non-sterile products and the selection and effectiveness of preservative systems in products