Aging facilities and utilities in pharmaceutical manufacturing present considerable challenges and multiple options for upgrades and enhancements.
- Do you rip and replace, starting from scratch with the latest equipment?
- Do you upgrade specific critical equipment only?
- Do you retrofit aging equipment to meet today’s standards?
The best place to start is with a strategic gap assessment, which takes a comprehensive look at your facilities, utilities, systems, and equipment, compares all components to current regulations and industry guidance, then prioritizes upgrades and replacements needed.
Continue reading to learn more about revalidation and our recommendations for maintaining a validated state.
3 Reasons to Perform a Revalidation
It’s Been Over 10 Years Since You Initially Qualified Your Facility
Ten years is a lifetime for a pharma manufacturing facility. With technology and knowledge advancing rapidly, your existing equipment and processes can quickly become outdated. Revisiting your validation maintenance program is a smart way to ensure your revalidation requirements reflect today’s standards.
Changing Regulations and Guidance
We keep up to date on the latest recommendations and mandates from the FDA, EMA, ICH, WHO, ISPE, PDA, ISO, as well as the many other global regulatory agencies and know how to keep your facilities and utilities in compliance. As industry regulations are constantly in flux, we can alert you in the future when a guidance change impacts any of your equipment or processes so you can plan to revalidate or upgrade accordingly.
You’re Planning to Manufacture a New Product
Equipment and utility requirements can vary greatly, even for similar products. Strategically coordinating the commissioning, qualification, and validation of your existing facilities and processes well before planned production can help you get to market faster.
Maintaining a Validated State
All of your equipment should maintain a validated state throughout its lifespan, but with differing recommendations on revalidation timelines, it’s generally not feasible and/or pragmatic to put each piece of equipment on a predefined validation schedule.
A solid change management program is your strongest asset when it comes to knowing when and how to revalidate your equipment. Ensure your quality system is structured to support a robust validation maintenance program.
Is It Time for a Revalidation of Your Facility?
Contact us to discuss your unique validation needs, including:
- • Cleaning Validation (CIP/COP)
- • Sterilization Validation (SIP/SOP)
- • Process Validation
- • Mixing Validation
- • Clean/Dirty Hold Validation
- • Expiry Validation
- • Computer System Validation (CSV)
- • Airflow Evaluation Validation
- • Validation Maintenance
- • Project Planning and Execution