Validation Protocols and Validation Services

Proven protocols and expertise to qualify Millipore products for use in your testing processes. cGMPs/cGLPs require equipment and test methods to be validated before routine use. This can be time consuming and delay the start of critical QC procedures. Receive prepared protocols and have your new QC systems validated quickly and efficiently by the experts at Millipore and save time with this process.

Validation Protocols

Millipore’s validation protocols are based on Millipore’s internal product qualification test methods. These extensive protocols will enable the QC/QA Lab to quickly initiate your Validation Master Plan and perform IQ, OQ and PQ (suitability of the test methodology) with ease. They follow international guidelines such as EP/USP and GMP.

Reduce the Development Time & Cost of the Validation

• The protocol preparation requires around 4 weeks (research on applicable regulations, acceptance criteria definition, test methods writing, formatting, etc)
  
• Estimated IQ/OQ completion time without pre-written protocol: 6 to 7 weeks
  
• Quickly integrate equipment into your process pipeline with confidence using product specific test methods

On-Site Validation Services

Rely on experts

Millipore has experienced and trained validation engineers who are skilled to assist in Validation Protocol implementation within the QC Microbiology laboratory, so the QC/QA Departments do not have to allocate resources. A complete and technical training on your Millipore equipment is also provided during the validation engineer’s visit. Rely on our expertise in various situations such as:

• New lab equipment
  
• New product or reformulated product to be tested
  
• Compliance with updated regulations: EP, USP, JP, etc.

Customize the service you need

IQ, OQ Service

Support for the qualification of laboratory equipment:

• Execution of the test methods
  
• Finalization of report, ready for QA approval
  
• Technical training

PQ Consultancy Service

Support for the implementation of microbiological tests (PQ) of the Validation Protocol:

• Detailed and complete presentations of microbiological test up to date with regulations
  
• On-site support for implementation of tests
  
• Tips and Tricks to optimize time and expendables quantity for the PQ
  
• On-site data analysis support and report generation
  
• Continued support over phone and email

Reduce the Validation Time & Cost

Having a Millipore Validation protocol and on-site service eliminates high costs, both apparent and hidden, and helps ensure the validation is completed quickly and economically.

Typical timing:

• Using Millipore protocol: 2 to 3 weeks
  
• With on-site validation service: less than a week.