MEPSCo GAMP

INDUSTRIES

Medical device and pharmaceuticals

Depending on your company’s needs, we’re here to ensure your medical device manufacturing equipment is fully compliant with GAMP standards.

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Procurement

Adhering to the structured GAMP process with thorough documentation to outline and develop the required manufacturing equipment.

Qualification

Ensuring the equipment meets regulatory and specified requirements.

Commissioning

Setting up and testing the equipment to ensure your systems are installed, configured, and functioning as intended.

Experience with equipment

With extensive experience in over 96 medical device manufacturing, I’ve worked on a diverse range of specialized machines. My expertise encompasses the entire process, from procurement to qualification.

Assembly

• Parts handling
• Web handling
• Leak detection
• Vision inspection
• Cutting / Punching
• Welding technologies

Assembly machine (80 ppm)

Assembly machine

Filling Lines

• Parts handling
• Fill / Capping / Torque
• Pumping technologies
• Vision inspection
• Data acquisition
• Reports

Monoblock 70 PPM

High speed filling

Labeling

• Peel & Place
• Printing
• Inspection
• Backing cut and disposal

Intermittent motion

Continuous motion 200 PPM

Process Development

• Process skids
• Suspensions
• POP / POC
• Prototyping
• Fill studies
• Process development

Mag particle suspension and filling

Pump cart for constant head pressure

Lyophilized Bead Manufacturing

• Small scale manufacturing
• Large scale manufacturing
• Bead handling
• Cartridge filling
• Auto fill LN2

High throughput frozen bead system, auto LN2 level

4-nozzle rotary frozen bead system

Manual cartridge filling tooling

THE MEPSCo PROCESS

Process to meet GAMP and cGMP compliant documentation

Over 23 years of industry experience and overcoming growing pains, MEPSCo has developed a comprehensive roadmap of 22 document types and protocols, all aligned with GAMP standards.

Whether you need one document type or the entire set, we’re here to assist.

Get a free consultation Download roadmap

Customer Interview and Presentation

Interviewing customer

Customer Requirement Document (CRD)

• Proof of principles and/or concept development (POP and/or POC)
• Budgetary URS (BURS)
• Budgetary quotes (BQ)

User Requirement Document (URS)

• Quotes
• Vendors analysis
• Project timeline and management (PT)
• Trace matrix (TM)

Functional Requirements Specification Document (FRS)

• Machine failure mode analysis (MFMEA)

Design Requirements Specification Document (DRS)

• Design review punch list and summary

Factory Acceptance Testing (FAT)

• Test method and document development
• FAT punch list

Equipment Delivery & Installation

Site Acceptance Testing (SAT)

• Test method and document development
• SAT punch list

Qualification and Validation

• Process failure mode evaluation and analysis (PFMEA)
• Engineering studies (ES)
• Validation plan (VP)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)

Release to Manufacturer

• Operator SOP
• PM SOP
• Incoming material specification

Benefits of working with MEPSCo

We’ve developed GAMP-compliant processes and documentation to streamline collaboration with manufacturing companies and automation vendors.

This approach ensures projects are delivered on time, within budget, and with minimal or no change orders.

Receive a more defined quote & costing for your equipment

Adhere to industry standards such as GAMP and cGMP

Increase your engineering group’s productivity

Equipment qualification and validation activities

Accessible and maintainable machines

World class OEE

Hear it from the people who knows us best

Matt Richard

Director of Manufacturing

"During the COVID-19 pandemic, Reza's contributions were nothing short of extraordinary. He played a pivotal role in designing and validating $150 million worth of equipment within a remarkably tight one-year timeframe. His ability to deliver such a monumental task on time and within budget is a testament to his expertise, dedication, and exceptional work ethic."

Eric Rhine

Director, Manufacturing Operations

“He understands what to address and at what stage of the project to get the best results possible. He made it possible for us to see our way through the issues and properly getting to the validation stage. Everyone on the team was thrilled to have him involved and it seemed like every time he got involved, we were able to get back on track due to his relentless insistence on staying the course and not getting sidetracked on non-value-added efforts."

Jerry Ter Laan

President

“He is well versed in all aspects of Automated Projects from mechanical to electrical design, assembly / fabrication methods, and testing. Automated Projects are multi-faceted entities that require the proper guidance for a succesful outcome. Reza has mastered this guidance through the development of protocols from the URS through PQ that state the requirements and test them throughout the duration of the project to ensure project success.”

Adam Baeuer

Assembly Operations Manager

“Reza’s knowledge of automated equipment, project management, validation requirements, Lean manufacturing, and preventative/predictive maintenance was a huge advantage while working together. Reza’s expertise in mechanical and systems/controls design was also a benefit. Reza used these skillsets to successfully validate and launch two (2) high volume pieces of automation into commercial production.”

Lori Yaphe-Delisle

President, Tourmaline Enterprises

"Reza is an innovative problem solver who is always in forward motion. He seeks the right solution by looking at the overall big picture as well as the challenge at hand. I believe American manufacturing needs more people like Reza Bashar."

Neil Tennant

Sales Account Executive

“Reza continually dedicates himself to the task at hand ensuring all projects he undertakes are executed in a timely manner, within budget, meeting expected outcomes and without sacrificing quality on any level.”

Dave Carlberg

Cofounder, Kinematic Automation, Inc.

"Reza’s deep knowledge and understanding of Automation and GAMP guidelines is also a significant benefit that he brings to the process."

Jim Neal

Sr. Director, Operations

"I have worked with Reza Bashar for over 10 years. Reza has proven to be a very detailed Engineer and has a strong quality focus when seeking out new equipment and equipment vendors. Reza has done a great job in ensuring equipment requirements are well-defined by the end user so that vendors are successful in providing equipment solutions that are thorough and complete."

James Decker

Manufacturing Engineer III

"I’ve had the pleasure of knowing and working with Reza Bashar at Hologic / Gen-Probe for well over ten (10) years on several difficult projects. His knowledge of the full GAMP process and over 23 years of experience in the Diagnostics industry as well as his out-of-the-box creativity, has made it possible to discover and address possible design flaws much earlier in the process of developing an automated manufacturing line and process."

Let’s be partners in manufacturing line development.

Experience

Over 23 years of experience working with 15+ automation companies and developing 96+ manual and automated manufacturing equipment and lines, ranging from small to large scale.

Proven track record

Delivered the desired outcome on-time and on-budget with minimal or no change orders.

rezabashar@mepsco-gamp.com

‭+1 (619) 843-9373‬

Located in Southern California.
Available anywhere in the world.

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Your partner in manufacturing line development.

Why work with MEPSCo?

Medical device and pharmaceuticals

Procurement

Qualification

Commissioning