Process Validation Services
How Can We Help?
We work with your team to determine what processes need to be validated. Then, we write the validation plans, protocols and reports. This includes the software, equipment, materials and facilities that make up the process.
We also offer off-the-shelf validation documentation that is ready to be customized by your team.
Our Process
Step
1
Define
The first step is to define the process. Flowcharts are a great tool for this and the actual task of making the flowchart provides a lot of value. You will be surprised how much you learn from the session.
Step
2
Evaluate
The next step is evaluation of the process; we need to decide what steps require validation. We will think through the equipment used, the activities that are performed at each step, facility requirements, and the material inputs and outputs to make this decision.
Step
3
Plan
The next step is to define the validation plan for each item on the flow chart that is identified as needing validation. The output of this phase is the Master Validation Plan and specific validation protocols. This step may include planning equipment IQ/OQ/PQs.
Step
4
Validate
Now, we are ready actually validate the process. This can take anywhere from a few days to a few months depending on the scope of the validation. We use a risk-based approach and leverage as much existing data as possible to streamline this step.
Step
5
Report
The final step in the initial validation is to collate the data and write the validation report. Once the report is signed, then the initial validation is complete. You can now officially say you have a validated process.
Step
6
Revalidate
Over time, you should continue to monitor the process, determine if/when changes should trigger revalidation and when improvements are needed. Routine monitoring is defined in the Master Validation Plan and ad hoc revalidations can be documented in a variety of ways.
What is Process Validation?
Process validation ensures the process can reliably make a product. Regulatory authorities such as FDA have published rules and guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high-quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential to product quality. FDA discourages medical device makers from relying solely on finished-product inspection. Quality should be built into products and processes at all steps of production. Product quality should be considered at the earliest possible stage rather than at the end of the manufacturing process.
When Does a Process Require Validation?
In 21 CFR 820.75 the FDA states where “the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.” This rule makes it clear that not all processes must be validated. The medical device maker is responsible for determining what processes to validate and what processes will rely on inspection data to assure quality. When the manufacturer has determined that validation is not required, that rationale should be documented.
Qualomics can help you with every step of the validation journey from concept to completion.
Learn More About…
- Laboratory and analytical equipment validation
- Equipment validation
- Computer system validation
- 21 CFR Part 11
- Data Integrity Testing
- Equivalency Studies
- Filling Line Validation
- Compounding Process Validation
- Cold Chain Validation
- Validation Maintenance
- HPLC and UPLC
- GE AKTA Fast Protein Liquid Chromatography (FPLC)
- UV/VIS Spectrophotometers
- Total Organic Carbon (TOC) analyzers
- Conductivity (manual and automated systems)
- Turbidity
- Analytical Balances and Micro Balances (USP <41> and <1251>
- pH Meters, Coulometers
- Multi-Mode Plate Readers
- qPCR
- MSID
- Charles River and Lanza Endotoxin Analysis (manual and automated)
- Gas Chromatograph
- Hydrogen Generators
- Zero Gas Generators
- Nitrogen Generators
- FTIR Spectrometers (ATR, Diffuse, Photoacoustic)
- ICP/MS
- Autotitrators (KF and Potenitometric)
- Polarimeters
- Melting Point Apparatus
- FLEX Analyzers
- Osmometers
- Vi Cell
- Liquid Handlers
- Biacore
- Plate Washers
- Centrifuges
- WFI generation, Storage and Circulation Systems
- Compressed Air Systems
- Depryogenation Tunnels
- Autoclaves
- CNC Routers and Mills
- Cryogenic Dewers and Data Loggers
- Freezers, Refrigerators and Ovens
- Biologics and Raw Materials Testing
- Liquid and Powder Filling Machines
- Uniformity of Dosage, Seal Force, Microbiological Ingress Testing
- Raw Material Characterization
- ELISA
- Endotoxin Testing
- Osmolality
- Surface Plasmon
- Cell Counting and Viability
- Cell Culture Multi-Analyte Testing
- Trace Element Analysis
- Gas Chromatography
- Water for Injection, WFI
- Bacteria and Fungi Identification
- USP and JP Requirements