Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

On 11 May 2021 the FDA published this final guidance for industry.

This guidance provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance, and improving supply of medicinal products.

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