European Index
2.2 Introduction
2.3 Introduction
2.3.P Quality overall drug product.pdf
3.2.P.1 Description and Composition of the Drug Product
3.2.P.2 Pharmaceutical Development
3.2.P.3.1 Manufacturer(s)
3.2.P.3.2 Batch Formula
3.2.P.3.3 Description of Manufacturing Process and Process Controls
3.2.P.3.4 Controls of Critical Steps and Intermediates
3.2.P.3.6 process-validation-1.pdf
3.2.P.3.7 process-validation-2.pdf
3.2.P.3.8 process-validation-3.pdf
3.2.P.3.9 process-validation-4.pdf
3.2.P.3.10 process-validation-5.pdf
3.2.P.4.1 Specifications for Crosscarmallose Sodium
3.2.P.4.2 Analytical Procedures for Crosscarmallose Sodium
3.2.P.4.3 Validation of Analytical Procedures for Crosscarmallose Sodium
3.2.P.4.4 Justification of Specifications for Crosscarmallose Sodium
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Magnesium Stearate
3.2.P.4.2 Analytical Procedures for Magnesium Stearate
3.2.P.4.3 Validation of Analytical Procedures for Magnesium Stearate
3.2.P.4.4 Justification of Specifications for Magnesium Stearate
3.2 P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Purified Water
3.2.P.4.2 Analytical Procedures for Purified Water
3.2.P.4.3 Validation of Analytical Procedures for Purified Water
3.2.P.4.4 Justification of Specifications for Purified Water
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Sodium Chloride
3.2.P.4.2 Analytical Procedures for Sodium Chloride
3.2.P.4.3 Validation of Analytical Procedures for Sodium Chloride
3.2.P.4.4 Justification of Specifications for Sodium Chloride
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.4.1 Specifications for Titanium Dioxide
3.2.P.4.2 Analytical Procedures for Titanium Dioxide
3.2.P.4.3 Validation of Analytical Procedures for Titanium Dioxide
3.2.P.4.4 Justification of Specifications for Titanium Dioxide
3.2.P.4.5 Excipients of Human and Animal Origin
3.2.P.4.6 Novel Excipients
3.2.P.5.1 Specification(s)
3.2.P.5.2.1 analytical-procedure-appearance.pdf
3.2.P.5.2.2 analytical-procedure-colorants.pdf
3.2.P.5.2.3 analytical-procedure-content-uniformity.pdf
3.2.P.5.2.4 analytical-procedure-dissolution.pdf
3.2.P.5.2.5 analytical-procedure-identification-efpiate.pdf
3.2.P.5.2.6 analytical-procedure-microbial-limits.pdf
3.2.P.5.3.1 validation-analytical-procedures-content-uniformity.pdf
3.2.P.5.3.2 validation-analytical-procedures-dissolution.pdf
3.2.P.5.3.3 validation-analytical-procedures-identification.pdf
3.2.P.5.4 Batch Analyses
3.2.P.5.5 Characterisation of Impurities
3.2.P.5.6 Justification of Specifications
3.2.P.6.7 reference-standards-1.pdf
3.2.P.6.8 reference-standards-2.pdf
3.2.P.6.9 reference-standards-3.pdf
3.2.P.6.10 reference-standards-4.pdf
3.2.P.6.11 reference-standards-5.pdf
3.2.P.7 Container Closure System
3.2.P.8.1 Stability Summary and Conclusion
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment
3.2.P.8.3 Stability Data