Regulatory CMC Documentation

Regulatory CMC Documentation

Chemical and Manufacturing Control (CMC) is a global term used by FDA to describe drug production and testing data. CMC documents are documents prepared in accordance with the guidelines for Industry, Analytical methods and Verification procedures (Chemical, Manufacturing and Control documents) for analytical methods and validation procedures related to drug manufacture, These documents were published by the Centre for Drug Evaluation and Research and the Centre for Evaluation and Research of Biological products in August 2000 and have any finalized or follow-up guidelines. CMC is an integral part of drug development, regulatory submission, and continuous marketing and life cycle management of pharmaceutical products. As the drug development of the dosage form moves from concept to commercialization, the breadth and depth of the CMC documents required in the submission increase. All submitted regulatory documents require CMC data, such as:

  • IND.
  • CTA.
  • MAA.
  • Variant.
  • NDA.
  • Annual report

Our Regulatory CMC Documentation will cover the following:

  • Characterization of active substances.
  • Formulation composition.
  • Raw materials for the production of active substances and finished dosage forms.
  • Description of product and process development.
  • Production process description.
  • Release and stability test data of active substances and dosage forms.
  • Analytical methods and specifications for the inspection and release of raw materials.
  • In-process control.
  • Containers and containment systems.
  • Advise on Quality by Design (QbD) programs and requirements for regulatory filing including developing CQA reports.
  • Review cGMP/GMP files, such as verification reports, analysis methods, batch records, stability procedures, etc.

Why Choose BOC Sciences?

Our scientists has extensive experience in global pharmaceutical regulation, due diligence, research, development, technology transfer, commercialization, life cycle management and compliance. We have a strong documentation team dedicated to global and Chinese submissions to support the regulation of CMC documents. In addition, CTD formats with version control or custom CTD formats can provide high quality to meet local requirements. In addition, comprehensive services for drug development and application are further ensured through the integration of IND-based toxicological, clinical and regulatory services.

References

  1. Sahoo, N., Manchikanti, P., & Dey, S. (2010). Herbal drugs: standards and regulation. Fitoterapia81(6), 462-471.
  2. Schwarz, S. W., Dick, D., VanBrocklin, H. F., & Hoffman, J. M. (2014). Regulatory requirements for PET drug production. Journal of Nuclear Medicine55(7), 1132-1137.
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