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Harmonised
Q5C

Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

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In Process
Q5C

Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

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Pre-harmonisation

Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

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Harmonised
Q5D

Q5D – Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

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In Process
Q5D

Q5D – Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

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Pre-harmonisation

Q5D – Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

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Harmonised
Q5E

Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

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In Process
Q5E

Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

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Pre-harmonisation

Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

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Harmonised
Q6A

Q6A – Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

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In Process
Q6A

Q6A – Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

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Pre-harmonisation

Q6A – Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

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Harmonised
Q6B

Q6B – Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

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In Process
Q6B

Q6B – Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

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Pre-harmonisation

Q6B – Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

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Harmonised
Q8(R2)

Q8 – Pharmaceutical Development

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In Process
Q8(R2)

Q8 – Pharmaceutical Development

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Pre-harmonisation

Q8 – Pharmaceutical Development

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Harmonised
Q8/Q9/Q10

Q8/Q9/Q10 – Implementation

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In Process
Q8/Q9/Q10

Q8/Q9/Q10 – Implementation

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Pre-harmonisation

Q8/Q9/Q10 – Implementation

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Harmonised
Q9(R1)

Q9 – Quality Risk Management

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In Process
Q9(R1)

Q9 – Quality Risk Management

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Pre-harmonisation

Q9 – Quality Risk Management

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