GMP Mapping & Validation (Cold Chain Packaging)
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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 for pharmaceuticals 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. The GMPs require that products are not affected during storage and transportation. While HPFBI has issued Guide-0069, to expand on Health Canada’s requirements for drug storage and transportation – they do not offer any concrete guidance on how to achieve GMP 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. 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: Mapping and Validation Studies:
Qualification or Verification Studies:
Validation Studies:
To find out more about our services in any of these areas, please contact us for an estimate. |
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