JM Hyde Consulting Inc.

We offer clients seven main categories of services:

JM HYDE PROGRAMS

Engineering

Process Design and Engineering

From the start of the design for a new facility to modification of an existing system, JM Hyde Consulting provides design and process systems integration services for biopharmaceutical and pharmaceutical facilities.

Areas of Expertise:

Equipment Engineering

Media Preparation
Cell culture
Upstream/Downstream processing

Facility Engineering

JM Hyde provides facility infrastructure project support for pilot and large scale manufacturing, which includes:

Basis of Design
P&IDs
Process Design Review
FAT/SAT Services
Maintenance/Spare parts programs
Hazard Analysis

Fill/Finish Engineering

Package development
Preclinical through Commercial

Cleaning Programs

JM Hyde Consulting is the world-wide leader in the design and implementation of pharmaceutical/biopharmaceutical cleaning processes and programs. We have designed and implemented cleaning programs resulting in licensing and approval for our clients.

Areas of Expertise

Clean In Place
Steam In Place

Services offered

Surveys and assessments of existing cleaning operations
Risk Assessment Analysis
Cleaning Equipment Engineering (CIP/SIP/COP)
Supportive Analytical Services
Customized Services such as

Contamination Root Cause Investigations/Prevention
Sterility Improvements Recommendations
SOP Development
Viral Inactivation Temperature Distribution Evaluation

Compliance and Validation Programs

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

Expertise Areas:

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

JM Hyde's approach to compliance integrates our entire portfolio of services. Our knowledge and experience in the Pharmaceutical and Biopharmaceutical industry, as well as an in-depth understanding of the FDA's risk-based management approach, provides added value for our clients.