In addition to growing regulatory pressures, and 100% raw material identity verification requirements, pharmaceutical and biopharmaceutical manufacturing sites are seeing an increase in new materials for which they must build new, thoroughly validated methods.
Biopharmaceutical and pharmaceutical manufacturers must follow good manufacturing practices (GMP) and adhere to the U.S. FDA 21 CFR Part 11 requirements. These requirements “set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”
As part of their GMP and FDA requirements, biopharmaceutical and pharmaceutical manufacturers must identify and authenticate their raw materials. Compliance and efficiency are top concerns for raw materials managers, but thoroughly analyzing all incoming materials takes time and resources, and methods for validations must be established.
Method development and validation teams, senior scientists and compliance and quality managers bear the burden of shipping samples around the world for method validation, a challenging, time-consuming and expensive process. However, there are now virtual applications that help enable globalized method validation using cloud computing to overcome many of these critical problems facing pharmaceutical manufacturers.
As an example, some manufacturers use material identification verification instruments utilizing Raman technology. In Raman spectroscopy, an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light, which can be absorbed, transmitted, reflected, or scattered by the sample. Light scattered from the sample is due to either elastic collisions of the light with the sample’s molecules (Rayleigh scatter) or inelastic collisions (Raman scatter). Whereas Rayleigh scattered light has the same frequency (wavelength) of the incident laser light, Raman scattered light returns from the sample at different frequencies corresponding to the vibrational frequencies of the bonds of the molecules in the sample.
Although this sounds very complicated, a non-expert operator can use a handheld Raman analyzer to accurately verify materials quickly.
In pharmaceutical manufacturing, Raman spectroscopy is suitable for incoming raw material identity verification, dispensing of materials during API manufacture, and counterfeit identification. Raman analyzer QA/QC applications include enhanced raw material ID for similar compounds, multiple component ID, and identification and quantification of intermediate and finished products. In PAT, applications include at-line endpoint determination for distillations, reaction monitoring, and powder blending operations.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S), Annex 8. PIC/S Annex 8 requires that individual samples be taken from all incoming containers and an identity test be performed on each sample. This is a major change from the traditional practice of allowing composite sampling of a statistical subset of the batch and identity testing of the single composited sample before releasing the batch to manufacturing. Individual container identity testing puts drastically higher demands on expert analysts’ time. The efficient use of portable Raman analyzers streamlines material verification and makes 100% material inspection cost-effective while maintaining high quality standards.
When cloud computing is paired with certain Raman analyzers, methods can be validated in the cloud without the need for physical samples, and materials can be tested against a full library with one click. Methods, signatures, and runs that are generated by a pharmaceutical material analyzer can be uploaded to an account, then accessed and reported upon. This allows for standardization of method validation processes across your organization. As a result, pharmaceutical companies can efficiently develop, validate, and manage compliant methods for the manufacturing of safe, quality products.
With a virtual pharmaceutical material identification application, wait times and costs associated with shipping physical materials are reduced, quarantined materials are released into production faster, and methods may be validated centrally allowing sites to focus on production. Users have access to any method or signature uploaded to their account rather than only those stored on an isolated instrument extending materials coverage with minimal invested time.
Having workflows across your scientific organization, streamlining analysis and providing a single source of truth are some of reasons cloud computing can help overcome some of the critical problems facing pharmaceutical manufacturers.
Cloud computing is a cornerstone of the digital transformation of any lab. It helps drive scientific acceleration by freeing the scientist from manual touchpoints and allowing mobile accessibility to instruments and the data analysis. Thermo Fisher Scientific offers an extensive portfolio of digital capabilities to aid you in your journey of digital transformation. Visit thermofisher.com/connecteverything to learn more.