Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance
Process validation is one of the biggest challenges drugmakers face. There are hundreds of individual manufacturing operations to validate, the terminology can be confusing and the required documents are sometimes unclear. Knowing exactly what the FDA and other regulators are expect of you when it comes to validation will pave the way for a more straightforward, successful process — and this management report can get you there.
Do you have a risk-based plan to determine which aspects of your business need validation? Is your team prepared to prove the consistent performance of your manufacturing equipment and its operating procedures? Have you validated the software used in your manufacturing?
With the Drugmaker’s Guide to Process Validation: Principles, Methods and Compliance management report, you’ll be able to align your validation choices with the expectations of regulators. You’ll discover the best methods for conducting a risk analysis, creating testing and sampling procedures and interpreting test results. With these expert tips, you will be able to develop an acceptable validation report and deal with any issues that may arise.
- The Basics of Validation
- Understanding different types of validation: prospective, retrospective and concurrent
- Determining roles concerning validation
- Matching the expectations of regulators
- Developing a Validation Master Plan
- Creating a master plan, validation matrix and validation protocol
- Setting the scope of the master plan
- Considering whether to outsource validation
- The Validation Process
- Applying risk management methods to validation
- Conducting risk analysis
- Defining critical quality attributes and process parameters
- Performing testing in different environments
- Writing test scripts
- Determining the advantages of executing test scripts electronically
- Interpreting results and preparing validation reports
- Dealing with validation problems
On top of expert advice, the report includes specific guidance from the FDA and international regulators along with sample documents you can use to ensure your validation program is robust and compliant.
Validation is a critical but challenging part of drug manufacturing. Find the information you need to develop a successful validation plan in this management report.
Order your copy today.
Who Will Benefit
- Drug manufacturers
- Contract manufacturers
- API suppliers
- Equipment design engineers
- Manufacturing directors and supervisors
- Quality management staff
- Production managers
- Risk management specialists
- Regulatory and compliance managers
- Inspections and audit specialists
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