In 2013 the FDA instituted the Drug Quality and Security Act, creating section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under section 503B, compounding facilities can choose to register with the FDA as an outsourcing facility. If a facility is registered with the FDA as an outsourcing facility to produce sterile drug…Details
We help you …
Address pain points
- Resolve deficiencies & citations
- Ensure regulatory compliance
- Maintain defensible audit trails
- with qualification & validation
- Assure quality & reliability
- Reduce recurring costs
- Mitigate risk
We’ve been designing and manufacturing a wide range of quality control instruments for over 30 years and by building them ourselves, we’ve gained a deep understanding of validation, calibration, and compliance. Few companies today have such comprehensive experience and knowledge of critical monitoring processes and how to make them meet operating regulatory guidelines. With Mesa, you’ve got a trusted partner with three decades of experience supporting you!
Trusted by the world’s leading brands …
- IQ/OQ/PQ Services & Documentation
- Warehouse Mapping
- Equipment Qualification & Calibration
- Process Control Validation
- Consulting & Assessment
- SOP Development
With Mesa’s Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and services, you can be assured that your equipment has been validated and is ready for use.
What impact does the HVAC system have on your warehouse hot spots? Does a change in airflow impact temperature equilibrium across the warehouse? What impact does the changing weather have on certain areas of the warehouse and how does that change throughout the year? Mesa will work with you and your team to look into every variable that may impact the viability of your product.
Mesa Global Services can provide IQ, OQ, IOQ, or PQ protocols to fit your validation needs. Our experience in the validation field allows us to create highly-customizable documents that will meet all of your design, product, company, and regulatory requirements.
Mesa can provide guidance for manufacturers working to meet the requirements of the FDA Code of Federal Regulations Title 21, Sections 820.70 and 820.75. Our staff is well versed in these regulations and we have the experience and expertise to assist in the planning and execution of the controls and procedures that need to be implemented.
From initial design to process qualification, Mesa is the ideal partner for GxP manufacturing consultation and support. Our relationship and participation within regulatory organizations globally offers Mesa the advantage of being able to stay on top of vital changes effecting our customers within the regulatory community. Our processes are highly scrutinized and we bring that same attention to detail to your processes and to your equipment.
At Mesa Labs, our sample Standard Operating Procedure (SOP) templates are written by engineers and product specialists, allowing the end user to customize the SOP to meet their unique needs.
Types of Validation
Mesa’s IQ protocols will:
- Record critical information applicable to the equipment, including equipment attributes such as the manufacturer, serial number, model number, equipment tag or asset number, materials of construction, and the location where the equipment will be installed.
- Record the system instrument and valve information, including the manufacturer, model number, materials of construction, and calibration information (if applicable).
- Verify the required utilities for the equipment, such as electrical, process gases, and/or steam.
- Verify documentation specific to the equipment, such as P&IDs, operation and maintenance manuals, purchase orders, component specifications, lubricants, equipment safety features, and the required spare parts.
Mesa’s OQ protocols will:
- Demonstrate and document that the equipment operates within predetermined limits when used under defined operating procedures.
- Test and record the operation of equipment security systems, sequence of operations, all modes of operation to meet user requirements, equipment alarms and interlocks, and any other specific requirements of the equipment.
- Document the verification of any applicable equipment parameters, sensors, switches, control devices, logic circuits, gauges, and any preventative maintenance requirements.
Mesa’s PQ protocols will:
- Verify that the equipment, previously verified to be installed and operational per user requirements, is able to consistently perform in accordance with the predetermined acceptance criteria.
- Verify and document the equipment can operate consistently and repeatedly under normal, less than optimal, and worst case conditions.
- Verify the alarm and interlock functionality under operational conditions.
Start managing your risk today
Partner models consist of a healthcare institution operating a specialty pharmacy in partnership or in contract with another entity to offer the full range of services required for an accredited specialty pharmacy. Accreditation standards are a valuable resource to healthcare pharmacy leaders to ensure that all internal and partner specific regulatory components are in place.…Details
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Mesa Labs’ Compliance and Validation Services expert Zach Sparks has more than 14 years’ experience in: IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers. Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet…Details