POINTS TO REMEMBER
ICH GUIDELINES
4 board categories– QSEM
✅ QUALITY
☑️ SAFETY
✔️ EFFICACY
✅ MULTIDISCIPLINARY
Q1 ➡️ Stability
Q2 ➡️ Analytical Validation
Q3 ➡️ Impurities
Q4 ➡️ Pharmacopoeias
Q5 ➡️ Quality of Biotechnology products
Q6 ➡️ Specifications
Q7 ➡️ Good manufacturing practices (GMP)
Q8 ➡️ Pharmaceutical Development
Q9 ➡️ Quality Risk Management
Q10 ➡️ Pharmaceutical Quality System
Q11 ➡️ Development and Manufacturing of drug Substance
Q12 ➡️ Lifecycle management
Q13 ➡️ Continuous manufacturing of Drug substance and drug product
Q14 ➡️ Analytical procedure development
SAFETY GUIDELINES
S1 ➡️ Carcinogenicity Studies
S2 ➡️ Genotoxicity Studies
S3 ➡️ Toxicokinetics and Pharmacokinetics
S4 ➡️ Toxicity Testing
S5 ➡️ Reproductive Toxicology
S6 ➡️ Biotechnology Products
S7 ➡️ Pharmacology Studies
S8 ➡️ Immunotoxicology Studies
S9 ➡️ Nonclinical Evaluation for Anticancer Pharmaceuticals
S10 ➡️ Photosafety Evaluation
S11 ➡️ Nonclinical Safety Testing
EFFICACY GUIDELINES
E1 ➡️ Clinical Safety for Drugs used in Long – Term Treatment
E2 ➡️ Pharmacovigilance
E3 ➡️ Clinical Study Reports
E4 ➡️ Dose – Response Studies
E5 ➡️ Ethnic Factors
E6 ➡️ Good Clinical Practice
E7 ➡️ Clinical Trials in Geriatric Population
E8 ➡️ General Consideration for Clinical Trials
E9 ➡️ Statistical Principles for Clinical Trials
E10 ➡️ Choice of Control Group in Clinical Trials
E11 ➡️ Clinical Trials in Pediatric Population
E12 ➡️ Clinical Evaluation by Therapeutic Category
E13 ➡️ Principles for Clinical Evaluation of New Antihypertensive Drugs
E14 ➡️ Clinical Evaluation of QT
E15 ➡️ Definitions in Pharmacogenetics/ Pharmacogenomics
MULTIDISCIPLINARY
M1 ➡️ MedDRA Terminology
M2 ➡️ *Electronic standards
M3 ➡️ Nonclinical Safety Studies
M4 ➡️ Common Technical Document
M5 ➡️ Data Elements and Standards for Drug Dictionaries
M6 ➡️ Gene Therapy
M7 ➡️ Genotoxic Impurities
M8 ➡️ Electronic Common Technical Document
