How To Write A Pharmaceutical Monograph

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Introduction and outcome: Pharmaceutical Monograph

A Monograph plays a vital role in managing the quality, safety and efficacy of the pharmaceutical. In this article, you will learn about the pharmaceutical monograph, its different sections, writing procedure, advantages and its advantages with FAQs

Pharmaceuticals Monograph

Pharmaceutical Monograph is a scientific document that describes the pharmaceutical’s properties, use, safety, storage conditions, specifications and quality control testing parameters along with the method of analysis.

How To Write A Pharmaceutical Monograph?

Standard test procedure(STP) and Analytical control/specification with test parameters are needed to prepare the monograph. Include the following sections while writing a pharmaceutical monograph:

• Structure with molecular formulae: This section contains structure and molecular formulae of the pharmaceutical
• Definition: This section contains content/purity/assay of the pharmaceutical
• Description: This section contains a concise description of the pharmaceutical, including its physical and chemical properties (colour, form, taste etc.)
• Solubility: This section contains the solubility of the pharmaceutical in the different solvents
• Identification: This section contains the identification tests and procedure with acceptance criteria of the pharmaceutical
• Assay: This section contains the assay test and procedure with the acceptance criteria of the pharmaceutical
• Impurities
  • Residue on ignition: This section contains the Residue on ignition test and procedure with acceptance criteria.
  • Heavy metals: This section contains the heavy metal test and procedure with acceptance criteria.
  • Organic impurities/Related substances test/Impurity profile test:This section contains the Organic impurities test and procedure with acceptance criteria.
• Loss on drying (LOD): This section contains the LOD test and procedure with acceptance criteria.
• Organic volatile impurities/Residual solvents: This section contains the Organic volatile impurities/Residual solvents test and procedure with acceptance criteria.
• Packaging and storage condition: This section contains packaging and storage condition of the pharmaceutical.
• References:
• Abbreviations:
• safety statement:

How to prepare the monograph?

Quality control experts prepare the monograph in coordination with quality assurance and analytical research experts.

Who approves the monograph?

The Monograph is approved by the quality control head, quality assurance head and analytical research .head.

Note: Additional departments can also be added as per organisation requirement.

Advantages

• Helpful in managing the quality and safety of the pharmaceutical
• Regulatory requirement
• Helpful in technology transfer

Example of Pharmaceutical monograph

• In-house monograph
• United States Pharmacopeia (USP) monograph
• European Pharmacopoeia (EP) monograph
• Indian Pharmacopoeia (IP) monograph
• British Pharmacopoeia (IP) monograph

Related topic: Analytical Method Development and Validation in Pharma

Conclusion

I hope this article has helped you understand the Pharmaceutical Monograph and its its writing procedure.

You may also want to check out other articles on my blog, such as:

• Challenges related to pharmaceutical quality control?
• GMP in Pharma: What is the importance?
• GDP: Quality Need
• How to write SOP?
• How to decide pharmaceutical raw material specifications?

FAQs

What is monograph of Indian Pharmacopoeia?

Indian pharmacopoeia monograph is used to perform analysis and manage the quality of the pharmaceuticals.

How to write a drug monograph?

Analytical control and STP (standard test procedure) are used to write drug monograph.

What is the difference between monograph and STP?

STP contains only test procedures whereas monograph contains test procedures, test parameters and specifications of any pharmaceutical.

References

What is a USP monograph?

Abbreviations

• STP: standard test procedure