Choose DSA Consultants to Put You on the Map for Good Manufacturing Practices.

Count on DSA Consultants to spearhead your mapping and validation studies to meet with regulatory and trade requirements. We’ll work with you to detail the following requirements:

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 and ICH (International Conference on Harmonization) Documents offer little guidance on the requirements, yet mapping and validation are hot topics and part of a major inspection trend with respect to the Health Products and Food Branch Inspectorate (HPFBI), for all products and not just those requiring a cold chain.

Transportation and Storage

The GMPs require that products are not affected during storage and transportation. While HPFBI has issued Guide-0069, to expand on requirements for mapping and validation – they do not offer any concrete guidance on how to achieve compliance. This leaves most companies unsure of how to comply. We can develop programs and protocols for you which help provide evidence that your handling of products complies with current requirements.

Computer Validation

The GMPs require that computer systems used in the manufacture, storage, and distribution of drug products are proven to be reliable and secure with respect to the storage of records. Where electronic signatures are used, GMPs require that systems are tested for security, validity, and reliability. Canadian companies are left trying to struggle between this minimum requirement and international pressures for compliance with FDA CFR 21 Part 11. DSA can develop protocols for validation of your computer systems and handle the validation for you.

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

Mapping and Validation Studies:

• Coolers
• Freezers
• Incubators
• Shipping Containers
• Transportation Vehicles
• Storage Areas

Qualification or Verification Studies:

• Packages
• Carriers
• Shipping Routes

Validation Studies:

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

Contact us to find out more information on how DSA can assist you with your mapping and validation projects. For more information on services offered, click here to request a copy of our free brochure.

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