How to validate a pharmaceutical process. (2016)

• Record Type: Book
• Further Information: Note: Steven Ostrove.
• Authors: Ostrove, Steve
• Contents: 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
• Publisher Details: Amsterdam : Academic Press
• Publication Date: 2016
• Extent: 1 online resource
• Subjects: 615.19; Pharmaceutical technology; Drugs -- Quality control; Pharmaceutical technology -- Standards
• Languages: English
• ISBNs: 9780128096536
• Related ISBNs: 9780128041482
• Notes: Note: Description based on CIP data; item not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.