Cleaning Validation Protocol Format and Acceptance Criteria
Cleaning validation protocol format for pharma: sections to include, example acceptance criteria for analytical methods, swab recovery, and common myths.
Validation
HPLC Calibration Guide Part 1: Parameters and Procedures
HPLC calibration explained: example calibration parameters and frequencies, with pressure test, drift and noise, oven, flow and gradient checks for QC labs.
Principles of Cleaning Validation in Pharma (Annex 15)
Principles of cleaning validation explained: lifecycle approach, worst-case selection, health-based limits (HBEL), visual clean, hold times and verification.
SOP on Cleaning Validation (Example Template)
Example SOP on cleaning validation for pharma plants: scope, responsibilities, protocol contents, worst-case selection and health-based (PDE) acceptance limits.
Validation Master Plan (VMP): Contents and Example Outline
What a validation master plan (VMP) is, what EU GMP Annex 15 expects it to cover, and an example VMP outline with a short explanation of every section.