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News: Quality Considerations for Continuous Manufacturing needs re-drafting.

The FDA, in February, released the "27-pages" of active guidelines that focus on the implementation of the continuous manufacturing in the Pharmaceutical industry. But that being said, the Drugmakers and major healthcare industries are incredulous to work on the Continuous Manufacturing, as it focuses on continuous manufacturing of the drugs, thus causing an inexplicable consistency in work and code of conduct.

Major Pharmaceutical firms have demanded the change in the guidelines should emphasize a clear-cut idea on the production steps involved in non-conformance materials as the "nonconforming material is not necessarily produced during those production steps depending on the manufacturer’s process design and controls", and have demanded to modify the guidelines with wordings such as "may" result in the non-conforming materials.