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What is Regulatory CMC Writing
27 Sep 2023

What is regulatory cmc writing?

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Regulatory CMC (Chemistry, Manufacturing, and Controls) writing is a specialized form of technical writing in the pharmaceutical and biotechnology industries.

What is CMC means?

Chemistry, manufacturing and controls; also referred to as pharmaceutical quality/CMC.

What is CMC documents?

These documents are typically submitted as part of a new drug application (NDA) or a marketing authorization application (MAA) to seek regulatory approval for a new drug. They play a crucial role in ensuring that the drug is safe, effective, and of consistent quality. Regulatory CMC writers need to have a strong understanding of pharmaceutical science, regulatory guidelines, and technical writing skills to prepare these documents effectively.

Learn more >> Importance of CMC documents

The Term CMC Writing

  • The term covers the various procedures used to assess the physical and chemical characteristics of drug products, and to ensure their quality and consistency during manufacturing. CMC data are an important part of submissions to regulatory authorities.
  • It involves the preparation of documents and reports that provide detailed information about the chemistry, manufacturing, and quality control aspects of a drug product.
  • These documents are submitted to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) or any other regulatory agencies, as part of the drug approval process.

Regulatory CMC writing training

What are the different components of the CMC writing services?

Mentioned below are the few of the key areas of the CMC writing where CMC writer will be working. They are responsible for preparing documents from these areas.

Drug Substance Description

This section provides information about the chemical structure and characterization of the active pharmaceutical ingredient (API) or drug substance. It includes details about the synthesis, purification, and analytical methods used to assess the quality and purity of the substance.

Drug Product Description

This section describes the drug product itself, including its formulation, dosage form, and manufacturing process. It covers aspects such as the composition of excipients, manufacturing equipment, and packaging.

Manufacturing Process

Detailed information about the manufacturing process is included, including the critical steps, equipment used, and process controls. This section ensures that the drug product can be consistently manufactured to meet quality and safety standards.

Quality Control and Testing

Regulatory CMC documents outline the quality control tests and specifications used to assess the quality, purity, and potency of the drug product. This includes information on analytical methods, acceptance criteria, and stability testing.

Stability Data

Data on the stability of the drug product over time is critical for demonstrating that it remains safe and effective throughout its shelf life. This section includes stability studies and data analysis. CMC writers need to prepare stability data which is important and must for the regulatory submission.

Batch Records

Copies of batch records from manufacturing are often included to demonstrate that the product has been manufactured according to established procedures.

Comparative Data

In some cases, comparative data may be included to demonstrate that the proposed drug product is equivalent to a reference product or a previously approved formulation.

Risk Assessment

A risk assessment may be included to identify and evaluate potential risks associated with the manufacturing process and product quality.

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