Berikut daftar guideline dan aturan Industri Farmasi dari ICH (The International Council for Harmonisation). ICH merupakan suatu badan harmonisasi semua aturan industri farmasi di dunia. Guideline dari ICH selalu menjadi rujukan bagi profesional industri farmasi dalam upaya kepatuhan terhadap pelaksanaan CPOB di Industri farmasi.
Harmonisasi aturan industri farmasi diaplikasikan pada bidang Kualitas mencakup pencapaian penting seperti pelaksanaan studi stabilitas, penentuan ambang batas yang relevan untuk pengujian pengotor, dan pendekatan yang lebih fleksibel terhadap kualitas farmasi berdasarkan manajemen risiko Good Manufacturing Practice (GMP)/CPOB.
Daftar Guideline dan Aturan Industri Farmasi
Q1A (R2) – Stability Testing of New Drug Substances and Products
Q1 B – Stability Testing : Photo Stability Testing of New Drug Substances and Products
Q1C – Stability Testing for New Dosage Forms
Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E – Evaluation of Stability Data
Q1F – Stability Data Package for Registration Application in Climatic Zones III and IV
Q1F Stability Guideline WHO 2018
Q2 (R1) – Validation of Analytical Procedures : Text and Methodology
Q2(R2)Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Q3A (R2) – Impurities in New Drug Substances
Q3B (R2) – Impurities in New Drug Products
Endorsed Document Q3B(R2) Concept Paper
Q3C (R5) – Impurities : Guideline for Residual Solvents
Guideline Q3C(R8) Guideline
WG Presentations / Trainings Q3C(R8) Step 4 Presentation
Other Documents Q3C Support Documents
Q3D – Impurities : Guideline for Elemental Impurities
Endorsed Documents Q3D Concept Paper
Q3D (R2) Maintenance EWG Revision of Q3D(R1) for cutaneous and trandermal products
Q3D(R2) Maintenance Concept Paper
WG Presentations / TrainingsQ3D(R2) Step 2 Presentation
GuidelineQ3D(R2) Draft Guideline
Q3D Training Implementation of Guideline for Elemtal Impurities
WG Presentations / Trainings Q3D Training Package Module 0-9
Q3E EWG Impurity: Assessment and Control of Extractables and Leachabes For Pharmaceuticals and Biologics
Q4A – Pharmacopoeial Harmonisation
The pharmacopoeial authorities, working together through the Pharmacopoeial Discussion Group (PDG), have been closely involved with the work of ICH since the outset and harmonisation between the major pharmacopoeias, which started before ICH, has proceeded in parallel.
Q4B – Evaluation and Recommendation of Pharmacopoeial Text for use in the ICH Regions
WG Presentations / Trainings Q4B Presentation
Other documents Q4B Frequently Asked Questions (FAQs)
Q4B Annex 1(R1) – Residue on Ignition /Sulphated Ash General Chapter
Q4B Frequently Asked Questions (FAQs)
Q4B Annex 2(R1) – Test for Extractable Volume of Parenteral Preparation General Chapter
Other document Q4B Frequently Asked Questions (FAQs)
Q4B Annex 3 (R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter
Other documents Q4B Frequently Asked Questions (FAQs)
Q4B Annex 4A(R1)
Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
Q4B Annex 4B(R1)
Q4B Annex 4C(R1)
Microbiological Examination of Non-Sterile Products: Tests for Specified Micro- Organisms General Chapter
Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Q4B Annex 5(R1) Disintegration Test General Chapter
Q4B Annex 6 Uniformity of Dosage Units General Chapter
Q4B Annex 7(R2) Dissolution Test General Chapter
Q4B Annex 8(R1) Sterility Test General Chapter
Q4B Annex 9(R1) Tablet Friability General Chapter
Q4B Annex 10(R1) Polyacrylamide Gel Electrophoresis General Chapter
Q10 Pharmaceutical Quality System
Q10 Pharmaceutical Quality System
Q13 Continuous Manufacturing of Drug Substances and Drug Products
Q13 EWG Continuous Manufacturing of Drug Substances and Drug Products
Q14 Analytical Procedure Development
Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Source : ICH Guideline
