ICH Q12 : TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT
https://database.ich.org/sites/default/files/Q12_Annexes_Step4_2019_1119.pdf
PDA Technical Report No.65 Technology Transfer
https://www.pda.org/bookstore/product-detail/6680-tr-65-revised-technology-transfer
ICH Q8/9/10 Q&As (R4) : Q8/Q9/Q10 Implementation
https://database.ich.org/sites/default/files/Q8_Q9_Q10_Q%26As_R4_Q%26As_0.pdf
ICH Q2(R1) : Validation of analytical procedures: Text and methodology
https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
ICH Q5A(R1) : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
https://database.ich.org/sites/default/files/Q5A%28R1%29%20Guideline_0.pdf
ICH Q5A(R2) : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
https://database.ich.org/sites/default/files/ICH_Q5A%28R2%29_Step2_draft_Guideline_2022_0826.pdf
ICH Q1A : Stability testing of new Drug Substances and products
https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf
ICH Q5E : Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
https://database.ich.org/sites/default/files/Q5E%20Guideline.pdf
ICH Q5D : Derivation and Characterization of Cells Substrates Used for Production of Biotechnological/Biological Products
https://database.ich.org/sites/default/files/Q5D%20Guideline.pdf
ICH Q2(R2) : Analytical procedure Development and revision of Q2 (R1) Analytical Validation
https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf