Understanding ICH Guidelines in Pharmaceutical Compliance

Pharmaceutical Sciences

Regulatory Affairs

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1. What does ICH stand for?

1990-International Conference on Harmonization for technical requirements of registration of pharmaceuticals for human use (hosted by EFPIA)1989-Initiated at WHO conference... 1990-International Conference on Harmonization for technical requirements of registration of pharmaceuticals for human use (hosted by EFPIA)1989-Initiated at WHO conference International Conference of Drug Regulatory Authorities (ICDRA) as trilateral talks (EU-US-Japan) with IFPMA-Joint RA-Industry initiative for harmonization of standards dealing primarily with Pharmaceutical Regulation

International Center for Healthcare

International Coalition of Health

Institute of Clinical Hypnosis

ICH stands for International Conference on Harmonization, which is a global initiative that brings together regulatory authorities and pharmaceutical industry to ensure the safety, quality, and efficacy of pharmaceutical products.

Explanation

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About This Quiz

Understanding ICH Guidelines In Pharmaceutical Compliance - Quiz

Explore the intricacies of ICH guidelines and their applications in the pharmaceutical industry. This study guide enhances understanding of regulatory standards, focusing on compliance and quality assurance in drug development. Ideal for professionals seeking to align with international health regulations.

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2. What does EFPIA stand for?

European Food & Packaging Inspection Agency

European Federation of Pharma Industries and Associations

Economic Forum for Policy Implementation and Action

European Financial Planning & Investment Association

EFPIA stands for European Federation of Pharma Industries and Associations, representing the pharmaceutical industry across Europe. The other options do not accurately describe the acronym EFPIA.

Explanation

EFPIA stands for European Federation of Pharma Industries and Associations, representing the pharmaceutical industry across Europe. The other options do not accurately describe the acronym EFPIA.

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3. What does IFPMA stand for?

International Federation of Pharmacy and Medical Associations

International Federation of Pharmaceutical Manufacturers Associations

International Federation of Pharma Manufactures and Associations

International Federation of Pharma Marketing Associations

IFPMA stands for International Federation of Pharma Manufactures and Associations, representing global research-based pharmaceutical companies and associations. It is dedicated to promoting public health and sustainable healthcare worldwide.

Explanation

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4. What does ICH E2E stand for?

ICH E2E2 - Pharmaceutical Regulations Revision

International Conference on Harmonisation Endorsement 2E

2005-PHARMACOVIGILANCE PLANNING. E2E

Integrated Compliance Handbook Eleventh Edition

ICH E2E refers to the International Conference on Harmonisation (ICH) guideline for pharmacovigilance planning issued in 2005.

Explanation

ICH E2E refers to the International Conference on Harmonisation (ICH) guideline for pharmacovigilance planning issued in 2005.

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5. What does CTD/eCTD (ICH M4) stand for?

Controlled Temperature Delivery (ICH M4)

Certified Test Drive (electronic CTD)

Common Technical Document (electronic CTD)-Common dossier structure for pharma submission2004-Current Version2003-Mandatory in EU and Japan, highly recommended in US and... Common Technical Document (electronic CTD)-Common dossier structure for pharma submission2004-Current Version2003-Mandatory in EU and Japan, highly recommended in US and Aus

Critical Technical Documentation (electronic CTD)

CTD stands for Common Technical Document, and eCTD refers to electronic CTD. This standardized format is used for pharmaceutical submissions since 2004, with the current version dating back to 2003. It is mandatory in the EU and Japan, while being highly recommended in the US and Australia.

Explanation

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6. What is the CTD organization based on input from 3 Expert Working Groups (EWG)?

There is no structured organization for CTD that involves input from Expert Working Groups (EWG)

Pyramid structure based on imput from 3 Expert Working Groups (EWG): Modular StructureM1: CV of experts, Risk Management + Regional... Pyramid structure based on imput from 3 Expert Working Groups (EWG): Modular StructureM1: CV of experts, Risk Management + Regional Requirements especially language/labeling requirementsM2: CTD TOC (2.1); Introduction (2.2), QOS (2.3), NonClinical Overview (2.4) and Summaries (2.6); Clinical Overview (2.5) and Summaries (2.7)M3: Quality (CMC/3.1 TOC) [Not totally harmonized]M4: Non-Clinical Study Reports (4.1 TOC)M5: Clinical Study Reports (5.1 TOC)EWG are:M4Q-Quality (CMC; pharmaceutical data; biologics/biotech)M4E-Efficacy (Clinical; Efficacy)M4S-Safety (Non-clinical Pharmocology and Tox)

CTD organization is based on input from 2 Expert Working Groups (EWG)

CTD organization follows a flat structure without involvement from Expert Working Groups (EWG)

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7. What are the components involved in ICH Drug Development based on the 'Core Dossier' Structure?

Drug Development Components: 1. Skipping Phase III trials for faster approval 2. Post-market surveillance only without prior clinical trials 3.... Drug Development Components: 1. Skipping Phase III trials for faster approval 2. Post-market surveillance only without prior clinical trials 3. Overlooking manufacturing site approval

Drug Development Components: 1. Pre-clinical Toxicology only 2. Phase I studies in a few patients without efficacy data 3. Immediate... Drug Development Components: 1. Pre-clinical Toxicology only 2. Phase I studies in a few patients without efficacy data 3. Immediate approval following Phase II trials

Drug Development Components: 1. Clinical Research Organization (CRO) management 2. Advertisement and Marketing Strategies 3. Herbal and Alternative Medicine Studies

Drug Development Components:1. Chemical or Biological Development (CMC)2. Pre-clinical Pharmacology (PK/PD) and Toxicology (GLP-Tox) and POC Efficacy3A. PhI-Safety (15-10 healthy... Drug Development Components:1. Chemical or Biological Development (CMC)2. Pre-clinical Pharmacology (PK/PD) and Toxicology (GLP-Tox) and POC Efficacy3A. PhI-Safety (15-10 healthy volunteers) looking for PK/PD, dose range finding, tolerability; could include disease patients in some incidences (Ph1/2)3B. Ph2-(50-200 patients) POC/POC target, PK, safety, efficacy (clinical and target through biomarkers); sometimes multiple dose3C. Ph3- (Large-1000's) randomized, typically double-blind study for statistical efficacy and safety (tox) [FDA requires 2 Ph3 studies for NDA)4. Manufacturing Site Approval (GMP compliance)5. Ph4 (may be required for approval) and Post-market surveillance

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8. What does ICH Module 3 cover?

ICH Q8 (R1) Pharmaceutical Development-CMC not totally harmonized -Covers Substance (3.2.S)1. Drug Substance (API)2. Info on manufacturer (name and address),... ICH Q8 (R1) Pharmaceutical Development-CMC not totally harmonized -Covers Substance (3.2.S)1. Drug Substance (API)2. Info on manufacturer (name and address), manuf. process and controls, control of materials and critical steps, process validation, manufacturing process development3. Characterization4. Control of drug substance5. Reference Standards6. Container closure system7. Stability-Covers Product (3.2P)1. Description/Comp DP2. Pharma Development (name, formulation, overages and excipients; see ICH Q8) based on sound scientific principles (note, overages to compensate for manuf or shelf life degradation NOT recommended)3. Manufacturer: including who, batch formula, process, control of critica steps/intermediates, process validation4. Control of exciients5. Control of drug product: (specification, analyticals, batch analysis, impurities not completely harmonized and justifications of specifications), KNOW REGIOAL DIFFERENCES

ICH Q1A Stability Testing of New Drug Substances and Products

ICH Q9 Quality Risk Management

ICH Q2(R1) Validation of Analytical Procedures: Definitions and Terminology

ICH Module 3 specifically refers to ICH Q8 (R1) Pharmaceutical Development-CMC that covers various aspects of drug substance and product development. The incorrect answers do not directly relate to the content covered in ICH Module 3.

Explanation

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9. What does ICH Module 4 cover?

ICH E3 Guidance on structure and content of clinical study reports

ICH E9 Guidance on statistical principles for clinical trials

ICH S2B Guidance on genotoxicity testing

ICH S7A GuidanceCovers Preclinical Testing (4.1, 4.2, 4.3)---usually requires at least 2 mammalian species for FDA4.2.1 Pharmacology: PK/PD, safety pharm,... ICH S7A GuidanceCovers Preclinical Testing (4.1, 4.2, 4.3)---usually requires at least 2 mammalian species for FDA4.2.1 Pharmacology: PK/PD, safety pharm, PD drug interactions4.2.2 PK: ADME, PK drug interactions, others4.2.3 Tox: Single-dose; repeat-dose tox and genotox (in vitro&in vivo); short-term/long-term carcino; repro/embryo tox; local tolerance; ADA; mechanistic studies; dependence; impurities and metabolites (not completely harmonized)

ICH Module 4 specifically covers preclinical testing and related aspects such as pharmacology, pharmacokinetics, toxicology, and other relevant studies necessary for drug approval.

Explanation

ICH Module 4 specifically covers preclinical testing and related aspects such as pharmacology, pharmacokinetics, toxicology, and other relevant studies necessary for drug approval.

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10. What does ICH Module 5 cover?

Mathematical Modeling

Chemical Stability

Covers Clinical (5.1-5.4)5.2 Tabular list of all clinical stuides5.3.1 Biopharmaceutical Studies: bioavail(BA) and bioequiv(BE); bioanalytical methods5.3.2 PK using human biomaterials:5.3.3... Covers Clinical (5.1-5.4)5.2 Tabular list of all clinical stuides5.3.1 Biopharmaceutical Studies: bioavail(BA) and bioequiv(BE); bioanalytical methods5.3.2 PK using human biomaterials:5.3.3 PK (healthy and patient tolerability; intrinsic factor PK test, extrinsic factor PK test)5.3.4 PD (healthy and patient PK/PD studies)5.3.5 Efficacy and Safety (controlled and uncontrolled clinical studies; analysis against claims and endpoints)5.3.6 Postmarket experience: Periodic Safety Update Reports for approved products; PV results5.3.7 Case Report Forms and Individual Patient Listing

Regulatory Submissions

ICH Module 5 specifically focuses on clinical studies, biopharmaceutical studies, pharmacokinetics (PK), pharmacodynamics (PD), efficacy and safety, postmarket experience, and case report forms.

Explanation

ICH Module 5 specifically focuses on clinical studies, biopharmaceutical studies, pharmacokinetics (PK), pharmacodynamics (PD), efficacy and safety, postmarket experience, and case report forms.

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11. What does MAA stand for?

Marketing Authorization Application (FDA NDA)-Full standalone application; complete application-Must include physiochemical, biological or microbiol tests; PK/PD and Tox; Clinical Trials-Usually... Marketing Authorization Application (FDA NDA)-Full standalone application; complete application-Must include physiochemical, biological or microbiol tests; PK/PD and Tox; Clinical Trials-Usually required for NCE/NME (chemical/biologic/radiochem not previously authorized) as well as others, including new fixed combinations

Medical Association of America

Master of Applied Arts

Marine Aquarium Association

MAA commonly stands for Marketing Authorization Application in the context of FDA submissions for new drugs, showcasing the regulatory process involved in gaining approval for marketing new pharmaceutical products.

Explanation

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12. What does MAA stand for in the context of pharmaceuticals?

Generic NCE (not universal for biologic/biosimilars yet)Must be essentially equivalent (API is the same; same pharmaceutical form; Bioequivalent or... Generic NCE (not universal for biologic/biosimilars yet)Must be essentially equivalent (API is the same; same pharmaceutical form; Bioequivalent or Therapeutic Equivalence (FDA)-M1, M2, and M3- original dossier must be available to reviewing CA/RA- IF Not Off-Patent, Innovator grants rights to information in original dossier- Written comfirmation from innovator is required, granting generic rights

Manufacturers' Authorized Agent

Medical Administration Association

Medication Assurance Agency

MAA stands for Marketing Authorization Application, which is a comprehensive submission of data related to a pharmaceutical product to obtain marketing approval from regulatory authorities.

Explanation

MAA stands for Marketing Authorization Application, which is a comprehensive submission of data related to a pharmaceutical product to obtain marketing approval from regulatory authorities.

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13. What does CAM stand for?

Computer-Aided Manufacturing

Complementary and Alternative Medicine, including traditional treatments or herbal remedies and prophylatics.-WHO initiatives for harmonizing, such as RS/2001/GE/29, from WHO... Complementary and Alternative Medicine, including traditional treatments or herbal remedies and prophylatics.-WHO initiatives for harmonizing, such as RS/2001/GE/29, from WHO meeting in Seoul-Generally simple registrations

Corrective Action Management

Certified Asset Manager

CAM typically refers to Complementary and Alternative Medicine in the context of healthcare.

Explanation

CAM typically refers to Complementary and Alternative Medicine in the context of healthcare.

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14. What are the 3 major terms associated with drug submissions?

Testing Verification Approval

3 Major Terms for Drug Submissions:QualitySafety Efficacy

Effectiveness Efficiency Safety

Regulation Compliance Monitoring

When submitting a drug for approval, the 3 major terms to consider are Quality, Safety, and Efficacy. These terms ensure that the drug meets the necessary standards for effectiveness, safety, and quality control in order to be approved for public use.

Explanation

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15. What is the purpose of ICH Q9?

Product Marketing Campaign Planning

Quality Risk Management -Seminal textRISK A-I-A-E = Process to Assess, Identify, Analyze, Evaluate RISKRISK Control = Control, Reduction, Acceptance

Supply Chain Optimization Strategy

Regulatory Compliance Protocol

ICH Q9 refers to Quality Risk Management and provides guidelines on risk assessment, identification, analysis, evaluation, and control in the pharmaceutical industry.

Explanation

ICH Q9 refers to Quality Risk Management and provides guidelines on risk assessment, identification, analysis, evaluation, and control in the pharmaceutical industry.

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16. What does ICH Q7(A) stand for?

ICH Q5(A) (Stability Testing of New Drug Substances and Products)

QA (Quality Assurance)

GMP (Guideline to the Industry)

ICH Q9(A) (Quality Risk Management)

ICH Q7(A) is a guideline that focuses on establishing GMP standards for the pharmaceutical industry.

Explanation

ICH Q7(A) is a guideline that focuses on establishing GMP standards for the pharmaceutical industry.

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17. What does CPP stand for?

Central Processing Unit - The primary component of a computer system that performs instructions

Certificate of Pharmaceutical Product - MAH Paperwork required for export/import of drug, includes certificate number, exporting country, importing country, product... Certificate of Pharmaceutical Product - MAH Paperwork required for export/import of drug, includes certificate number, exporting country, importing country, product name and dosage form, API and amount/unit dose,marketing information, product information, applicant name and address, information pertaining to inspections, GMP status.-May require authentication stamp (apostille)

Common Programming Practice - Standard practices followed in programming

Certified Professional Photographer - A designation for professional photographers

CPP in the context provided refers to Certificate of Pharmaceutical Product, a crucial document for drug import/export.

Explanation

CPP in the context provided refers to Certificate of Pharmaceutical Product, a crucial document for drug import/export.

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