Compliance and Validation Programs

Our goal at Hyde Engineering + Consulting is to provide our clients with high quality, cost-effective compliance and validation solutions for the manufacturing, processing, and distribution of drug products.

Specific areas of expertise include:

• Risk-Based Compliance Management
• Strategic Validation Documentation
• Integrated Commissioning and Qualification
• Cleaning Validation

Approach to Compliance

Our approach at Hyde E+C to compliance integrates our entire portfolio of services and coupled with an in-depth understanding of the FDA's risk-based management approach, provides added value for our clients.

Our cGMP compliance services focus on systems that are common among pharmaceutical and biopharmaceutical manufacturers.

The 6 "Key Systems" Include:

• Quality Systems
• Facilities and Equipment Systems
• Materials Systems
• Production Systems
• Packaging and Labeling Systems
• Laboratory Control Systems

Hyde provides in-depth audits and GAP Analyses with respect to "cGMP" compliance, as defined by the Center for Biologics Evaluation and Research aiding our clients in preparation for any level of inspection.

Compliance Services Include:

• Mock FDA GMP inspections
• Remediation of FDA 483s and warning letters
• Corrective Action Programs (CAPAs)
• Contract manufacturers and lab audits
• Failure assessment investigation
• Quality System Evalution
  

Validation Services

A comprehensive approach to validation is core to our company's complete service offerings. In addition to providing traditional validation services, we also provide a fully integrated engineering and commissioning service. Our services include:

• Validation Master Plans
• Cleaning Validation
• Software Validation
• Commissioning Master Plans
• Equipment Validation
• Analytical Method Validation

We offer a full range of validation services for the manufacturing of bulk and final biopharmarmaceutical and pharmaceutical products.

Validation Services Experience

At Hyde, our process systems expertise spans a full range of process engineering and process validation services for the manufacturing of bulk and final pharmaceutical and biopharmaceutical products. We have experience in all phases of the process validation Life Cycle including:

• Validation Master Plans
• Cleaning Validation
• Process Design
• Commissioning
• Analytical Method Validation
• Installation (IQ)
• Operation Qualification (OQ)
• Computer Qualification (CQ)
• Performance Qualification (PQ)

Download the Compliance Engineering datasheet (PDF)

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