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Harmonised

Q4B Annex 3 – Test for Particulate Contamination: Sub-Visible Particles General Chapter

In Process

Q4B Annex 3 – Test for Particulate Contamination: Sub-Visible Particles General Chapter

Pre-harmonisation

Q4B Annex 3 – Test for Particulate Contamination: Sub-Visible Particles General Chapter

Harmonised

Q4B Annex 4A – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

In Process

Q4B Annex 4A – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

Pre-harmonisation

Q4B Annex 4A – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

Harmonised

Q4B Annex 4B – Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter

In Process

Q4B Annex 4B – Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter

Pre-harmonisation

Q4B Annex 4B – Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter

Harmonised

Q4B Annex 4C – Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

In Process

Q4B Annex 4C – Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Pre-harmonisation

Q4B Annex 4C – Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

Harmonised

Q4B Annex 5 – Disintegration Test General Chapter

In Process

Q4B Annex 5 – Disintegration Test General Chapter

Pre-harmonisation

Q4B Annex 5 – Disintegration Test General Chapter

Harmonised

Q4B Annex 6 – Uniformity of Dosage Units General Chapter

In Process

Q4B Annex 6 – Uniformity of Dosage Units General Chapter

Pre-harmonisation

Q4B Annex 6 – Uniformity of Dosage Units General Chapter

Harmonised

Q4B Annex 7 – Dissolution Test General Chapter

In Process

Q4B Annex 7 – Dissolution Test General Chapter

Pre-harmonisation

Q4B Annex 7 – Dissolution Test General Chapter

Harmonised

Q4B Annex 8 – Sterility Test General Chapter

In Process

Q4B Annex 8 – Sterility Test General Chapter

Pre-harmonisation

Q4B Annex 8 – Sterility Test General Chapter