Process Validation Protocol for Soft Gelatin Capsule

We are going to manufactured soft gel capsule first time in our site (progesterone 100 mg). Please give me some information regarding process validation protocol of soft gel. What are the critical parameters, sampling frequency, sampling method?

This is a ‘BIG’ question! Usually, in an SOP you have sections labelled as:

  1. Purpose
  2. Scope
  3. Responsibilities (Operations, QA, QC, Validation…)
  4. Definitions
  5. Policies and Procedures
  6. Guidelines (FDA, EMA, Health Canada…)
  7. Process Description (Compounding, Encapsulation, Seal Thickness, Drying, Sorting…)
  8. Protocol Structure and Numbering (for every protocol there should be a similarly numbered final report)
  9. Approvals

Like everything the manufacturing equipment must be ‘commissioned and qualified’ per the ISPE baseline guide (IQ/OQ/PQ). Your ‘critical process parameters (CPP)’ are what is necessary to make your drug product like temperature maintained by the Fenwalls, rpm of the compounding tank shaft, seal thickness and shell thickness, KFR of the dried capsules… Beginning, middle, end, top, middle, bottom of the assay, related substances. Think time, temperature, pressure, weight