Specifications and Tests

Guidance’s and References for setting Specifications, Test methods, Acceptance criteria for Drug products (Formulations, Dosage Forms) and Drug substances (APIs) – Assay, Content, Impurity controls, Microbial controls, Elemental Impurities, Mutagenic/ Carcinogenic impurities, Nitrosamines, NDSRIs, Residual Solvents, General Characteristics; Pharmacopeia requirements: USP, EP; Regulatory guidelines: ICH, USFDA, EMA,

• ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances And New Drug Products: Chemical Substances
• ICH Q6A: Specifications: Decision Tree
• ICH Q6B: Specifications: Test procedures and Acceptance criteria for Biotechnological / Biological products
• ICH Q3A(R2): Impurities in new Drug substances
• ICH Q3B(R2): Impurities in new Drug products
• ICH Q3C(R8) Impurities: Guideline for Residual Solvents
• ICH Q3D(R2): Guideline for Elemental Impurities
• ICH M7(R2): Assessment and control of DNA reactive (Mutagenic) impurities in Pharmaceuticals to limit potential Carcinogenic risk
• ICH Addendum to M7(R2): Application of the principles of the ICH M7 Guideline to calculation of compound-specific Acceptable Intakes
• ICH M7(R2): 2nd Addendum Step 4 document.
• ICH M7(R2) Q&As: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk; Questions and Answers
• VICH: GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances – Scientific guideline (VICH: GL39)
• EMA (European Medicines Agency): Specifications and control tests on the finished product – Scientific guideline
• EMA (European Medicines Agency): Setting specifications for related impurities in antibiotics – Scientific guideline
• USP General chapters: General Tests & Assays – General requirements for tests and assays (Access from USP)
  • Chapter 1: Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
  • Chapter 2: Oral Drug Products—Product Quality Tests
  • Chapter 3: Topical and Transdermal Drug Products—Product Quality Tests
  • Chapter 4: Mucosal Drug Products—Product Quality Tests
  • Chapter 5: Inhalation and Nasal Drug Products—General Information and Product Quality Tests
• USP<466> Ordinary Impurities (Access from USP)
• USP<476> Control of Organic Impurities in Drug Substances and Drug Products (Access from USP)
• USP<1086> Impurities in Drug Substances and Drug Products (Access from USP)
• USP<1111> Microbiological Attributes of Nonsterile Pharmaceutical products & USP <1111>: Microbiological examination of Nonsterile products: Acceptance criteria for  Pharmaceutical preparations Substances for Pharmaceutical use (Access from USP)
• USP<1115> Bioburden Control Of Nonsterile Drug Substances And Products (Access from USP)
• USFDA: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
• USFDA: FDA advises drug manufacturers that Burkholderia cepacia complex (BCC) poses a contamination risk in non-sterile, water-based drug products
• European Pharmacopeia (Access from EP or Ph.Eur):
  • Substances for Pharmaceutical Use (2034);
  • 10. Control of impurities in substances for Pharmaceutical use (51000)
  • 4. Residual Solvents
• USFDA : Policy on testing ethanol isopropyl alcohol for methanol
• USFDA: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
• USFDA : Establishing Impurity Specifications for Antibiotics (April 2026)