"Excellence in Service"

Gavin Pharmaceutical Services is a Good Manufacturing Practices (GMP) Consulting company. We offer many services that can make the difference between GMP success and failure. Here are a few examples:

Key GMP Services

• Design Review
• Equipment Procurement
• Project Management
• Commissioning
• GMP Systems Analysis
• GMP Filling, Closing, Packaging
• Calibration
• Technical Training
• Complex Troubleshooting

Capabilities

Design Review

Fantastic execution of a bad design is a ticket to disaster. We review conceptual designs for room layout, flow of raw material, people, in-process material, packaging, finished product, and even trash.  Detailed design review includes all that, and architectural detail, sewer detail, mechanical detail, process equipment detail, control design, and much more. 

Equipment Procurement

We still find it surprising that the same mistakes in the procurement of GMP equipment is still being made 30 years after the "new" GMP regulation became effective. We can set the procurement process straight to maximize your success. 

Project Management

GMP projects are a different breed. Incorporating the critical GMP differences can save you money, possibly even your career. We offer a wide variety of project management services.

Commissioning

Commissioning is a systematic, begin-with-the-end-in-mind process. It is designed to organize, plan, execute, and document a wide variety of start up activities by various professionals involved in delivering your project. The result: a leveraged, more effective project. We can provide a wide range of professional commissioning services.

GMP Systems Analysis

We use flow charts, document analysis, staff interviews, and targeted audits to evaluate your existing GMP systems. If applicable, we design new systems for your plant or expansion.

GMP Filling, Closing, Packaging

We know how to fill, close, label, and package in compliance with Good Manufacturing Practice. We help validate your product packaging process.

Calibration

Pharmaceutical metrology  (calibration) has its distinctives from general industrial metrology. We understand the difference between open and closed loop calibration, and the FDA concerns about the wrong choice of calibration technology. We can design or modify your metrology program. We also perform temperature, pressure, and other in-house calibration. 

Technical Training

Training your staff for today's validation requirements is a big challenge. Sure, there are plenty of very expensive seminars available. You can attend most pharmaceutical trade or professional organizations and hear someone talk about validation. After all, it has been a legal requirement since 1979. Frankly, most of these resources share the same shortcoming: they are long on theory, and short on practice. At Gavin Pharmaceutical Services (GPS), we believe in sound validation practice, and we teach it better than anyone. We teach in many other GMP related technical areas, as well.

Complex Troubleshooting

Complex troubleshooting is an analytical approach to find and correct problems that are by nature complex, meaning there are two or more related causal factors. Normal methods are inadequate. Specialized areas of troubleshooting include: sterility failure, batch failure, equipment failure, process failure, validation failure, cross contamination, sterile filtration failure, QC laboratory failure.

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