Mapping & Validation

One of the most frequent questions we receive from clients is on how they achieve compliance with respect to Good Manufacturing Practices (GMP) Requirements for Mapping & Validation from manufacture through to delivery.

Health Canada Guidance Documents offer little guidance on the requirements, yet mapping and validation for pharmaceuticals are a major focus of Health Canada Inspections; for all types of products and not just those requiring cold-chain storage.

For some pharmaceuticals and biologicals that require cold chain packaging, manufacturers are taking steps to ensure that even the patient is capable of continuing the cold chain continuum. DSA Consultants have worked with several clients to develop patient bags and coolers that can be used to help the patient maintain the cold chain continuum.

DSA offers a wide range of services with respect to mapping, qualification & validation:

MappingMapping and Validation Studies:

• Coolers (IQ/OQ/PQ)
• Freezers (IQ/OQ/PQ)
• Incubators (IQ/OQ/PQ)
• Shipping Containers
• Transportation Vehicles
• Storage Areas

Qualification or Verification Studies:

• HVAC (IQ/OQ/PQ)
• Packages
• Carriers
• Shipping Routes

Validation Studies:

• Computers
• Analytical Methods
• Manufacturing Process
• Cleaning
• Equipment