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Daftar Guideline dan Aturan Industri Farmasi

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 industri farmasi
Daftar ICH Guideline

Daftar Guideline dan Aturan Industri Farmasi

Q1A (R2) – Stability Testing of New Drug Substances and Products

Q1A(R2) Guideline

Q1 B – Stability Testing : Photo Stability Testing of New Drug Substances and Products 

Q1B Guideline

Q1C – Stability Testing for New Dosage Forms

Q1B Guideline

Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Q1D Guideline

Q1E – Evaluation of Stability Data

Q1E Guideline

Q1E Presentation

Q1F – Stability Data Package for Registration Application in Climatic Zones III and IV

Q1F Stability Guideline WHO 2018

Q1F Explanatory Note

Q2 (R1) – Validation of Analytical Procedures : Text and Methodology

Q2(R1) Guideline

Q2(R2)Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

Q2(R2)/Q14 Concept Paper

Q2(R2)/Q14 Business Plan

Q2(R2)/Q14 Work Plan

Q3A (R2) – Impurities in New Drug Substances

Q3A (R2)

Q3B (R2) – Impurities in New Drug Products

Q3B(R2) Guideline

Endorsed Document Q3B(R2) Concept Paper

Q3C (R5) – Impurities : Guideline for Residual Solvents

Q3C Concept Paper

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Guideline Q3C(R8) Guideline

WG Presentations / Trainings Q3C(R8) Step 4 Presentation

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Other Documents Q3C Support Documents

Q3D – Impurities : Guideline for Elemental Impurities 

Q3D(R1) Guideline

Endorsed Documents Q3D Concept Paper

Q3D Business Plan

Q3D (R2) Maintenance EWG Revision of Q3D(R1) for cutaneous and trandermal products

Q3D(R2) Maintenance Concept Paper

Q3D(R2) Maintenance Work Plan

WG Presentations / TrainingsQ3D(R2) Step 2 Presentation

GuidelineQ3D(R2) Draft Guideline

Q3D Training Implementation of Guideline for Elemtal Impurities

Q3D Training Concept Paper

Q3D Training Business Plan

WG Presentations / Trainings Q3D Training Package Module 0-9

Q3E EWG Impurity: Assessment and Control of Extractables and Leachabes For Pharmaceuticals and Biologics

Q3E Concept Paper

Q3E Business Plan

Q3E Work Plan

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

Q4B Guideline

WG Presentations / Trainings Q4B Presentation

Other documents Q4B Frequently Asked Questions (FAQs)

Q4B Annex 1(R1) – Residue on Ignition /Sulphated Ash General Chapter

Q4B_Annex_1_R1__Step4Download

Q4B Frequently Asked Questions (FAQs)

Q4B Annex 2(R1) – Test for Extractable Volume of Parenteral Preparation General Chapter 

Q4B Annex 2(R1)

Other document Q4B Frequently Asked Questions (FAQs)

Q4B Annex 3 (R1) Test for Particulate Contamination: Sub-Visible Particles General Chapter

Q4B Annex 3(R1)

Other documents Q4B Frequently Asked Questions (FAQs)

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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

BACA JUGA  List of Pharmaceutical Manufacturer in United States Of America

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

Q13 Business Plan

Q13 Concept Paper

Q13 Work Plan

Q2(R2)/Q14 EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

Q2(R2)/Q14 Concept Paper

Q2(R2)/Q14 Business Plan

Q2(R2)/Q14 Work Plan

Source : ICH Guideline

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M. Fithrul Mubarok, M.Farm.,Apt adalah Blogger Professional Farmasi Industri pertama di Indonesia, pendiri dan pengarang dari FARMASIINDUSTRI.COM sebuah blog farmasi industri satu-satunya di Indonesia. Anda dapat berlangganan (subscribe) dan menfollow blog ini untuk mendapatkan artikel terkait farmasi industri. Email: fithrul.mubarok23@gmail.com
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