ICH Q2(R2) QUALITY GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES

Q3D(R2) Elemental Impurities

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

Benefit-Risk Considerations for Product Quality Assessments

ICH Q3C(R8) QUALITY GUIDELINE IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics

CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

Providing Over-the-Counter Monograph Submissions in Electronic Format

M12 Drug Interaction Studies

Risk Management Plans To Mitigate the Potential for Drug Shortages

Drug Products, Including Biological Products, that Contain Nanomaterials

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials

Guideline on quality documentation for medicinal products when used with a medical device

IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations

ICH Q3A(R2) QUALITY GUIDELINE IMPURITIES IN NEW DRUG SUBSTANCES

ICH Q3D(R2) QUALITY GUIDELINE GUIDELINE FOR ELEMENTAL IMPURITIES

Changes to Disposable Manufacturing Materials: Questions and Answers

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

ICH guideline Q9 (R1) on quality risk management

Reflection Paper on the Use of Artificial Intelligence (AI) in the Medicinal Product Lifecycle

Inspection of Injectable Products for Visible Particulates

Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators : Draft Guidance for Industry

Microbiological Quality Considerations in Non-sterile Drug Manufacturing