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Harmonised
Q3A(R2)

Q3A – Impurities in New Drug Substances

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In Process
Q3A(R2)

Q3A – Impurities in New Drug Substances

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Pre-harmonisation

Q3A – Impurities in New Drug Substances

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Harmonised
Q3B(R2)

Q3B – Impurities in New Drug Products

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In Process
Q3B(R2)

Q3B – Impurities in New Drug Products

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Pre-harmonisation

Q3B – Impurities in New Drug Products

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Harmonised
Q3C(R9)

Q3C – Guideline for Residual Solvents

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In Process
Q3C(R9)

Q3C – Guideline for Residual Solvents

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Pre-harmonisation

Q3C – Guideline for Residual Solvents

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Harmonised
Q3D(R2)

Q3D – Guideline for Elemental Impurities

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In Process
Q3D(R2)

Q3D – Guideline for Elemental Impurities

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Pre-harmonisation

Q3D – Guideline for Elemental Impurities

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Harmonised
Q4A

Q4A – Pharmacopoeial Harmonisation

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In Process
Q4A

Q4A – Pharmacopoeial Harmonisation

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Pre-harmonisation

Q4A – Pharmacopoeial Harmonisation

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Harmonised
Q4B(R1)

Q4B – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

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In Process
Q4B(R1)

Q4B – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

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Pre-harmonisation

Q4B – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

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Harmonised
Q4B Annex 1(R1)

Q4B Annex 1 – Residue on Ignition/Sulphated Ash General Chapter

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In Process
Q4B Annex 1(R1)

Q4B Annex 1 – Residue on Ignition/Sulphated Ash General Chapter

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Pre-harmonisation

Q4B Annex 1 – Residue on Ignition/Sulphated Ash General Chapter

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Harmonised
Q4B Annex 2(R1)

Q4B Annex 2 – Test for Extractable Volume of Parenteral Preparations General Chapter

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In Process
Q4B Annex 2(R1)

Q4B Annex 2 – Test for Extractable Volume of Parenteral Preparations General Chapter

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Pre-harmonisation

Q4B Annex 2 – Test for Extractable Volume of Parenteral Preparations General Chapter

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