HPLC Related Substances Validation Templates Bundle

The Ultimate HPLC Related Substances Validation Templates Bundle

Author: Mirela Gorjanu

Publisher: Practical Pharma Science

Overall Rating: ⭐⭐⭐⭐⭐ (5.0/5) (Professional Grade)

Individual Scores

• Technical content⭐⭐⭐⭐⭐(5.0/5)
• Regulatory alignment⭐⭐⭐⭐⭐(5.0/5)
• Practical usefulness⭐⭐⭐⭐⭐(5.0/5)
• Organization⭐⭐⭐⭐⭐(5.0/5)
• Educational value⭐⭐⭐⭐⭐(5.0/5)
• Laboratory applicability⭐⭐⭐⭐⭐(5.0/5)

Strengths

All documents are in compliance with current Pharmaceutical Regulations: US FDA 21 CFR Part 11 and cGMP, EU GMP Annex 11, ICH standards (Q2(R2), Q14, Q10), WHO and PIC/S data integrity frameworks, MHRA guidance, and ISPE GAMP 5.

The package combines three complementary resources:

• A comprehensive validation report covering specificity, forced degradation, LOD/LOQ, linearity, accuracy, precision, intermediate precision, and regulatory conclusions.
• A structured SOP with document control, scope, reagents, chromatographic conditions, solution preparation, calculations, acceptance criteria, and execution sequence.
• An Excel calculator that supports the validation calculations, making the package much more practical for training and day-to-day use.