How to Properly Validate a Pharmaceutical Process

Preface * Introduction New & Legacy Products The three phases of PV What it will attempt to do Product Status Section I - What is Process Validation and Why do Process Validation? * Defining Process Validation * Risk Based Approach * Good Science * Brief Review of the Regulations and Guidelines *21CFR * ICH * Other regulatory information * The Role of Change Control Section II - Stage I - Process Development * Starting the Process Validation Program * Validation Master Plan * SOPs * Quality Programs * Equipment and Utility Qualification * Determining what needs to be done * Direct * Indirect * System Boundaries * Commissioning * Qualification * IQ * OQ * PQ * Dealing with Computers and Automation Validation * General Computer System Validation * Part 11 * Process Development * Risk Assessment * Process Description (Defining the process) * Critical v. Non-Critical * Determining CPPs and CQAs * What variables are in the process * Why are they variable? * Can they be controlled? Section II - Process Qualification * The Process Validation Protocol * What makes a good protocol * Sampling Plans for Process Validation * Conducting the Process Validation protocol * Solid Dose * Creams, Liquids and Ointments * Parenterals * Preparing theProcess Validation report * Dealing with Deviations * Investigations * Resolution Section III - Continued Process Verification * Collecting and Evaluating Production * Use of Control Charts * Use of Statistical Process Control - pPk, Pk, cPk, cP Section IV - Other Related Activities * Cleaning- Verification to Validation * Facility Qualification