Learn about monographs and standard testing procedures (STP), key differences, writing process, and benefits with FAQs.
A Pharmaceutical Monograph is a comprehensive scientific document detailing a pharmaceutical’s properties, usage, safety, storage, specifications, and quality control parameters, while a Standard Test Procedure (STP) is a precise analytical document outlining the step-by-step methodology for conducting specific tests, prepared in accordance with the validated analytical method.
In this article, I will discuss the Monograph and Standard Test Procedure (STP), key differences, writing procedure, and advantages with FAQs.
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.
Examples:
A standard Test procedure is an Analytical document that contains a detailed analysis procedure of any test. STP is designed and prepared according to the method.
Examples:
| Aspect | Monograph | Standard Test Procedure (STP) |
| Definition | A detailed document outlining specifications and tests for a substance or product. | A specific, step-by-step guide for performing an individual analytical test. |
| Purpose | To provide a complete quality standard for a pharmaceutical substance or product. | To standardise how a particular test is to be performed in the lab. |
| Document Owner | Analytical Research | Quality Control and Quality Assurance |
| Prepared By | Analytical scientist | QC Chemist |
| Prepared from | It may be In-house or pharmacopoeia | Prepared from standard test procedure and analytical control |
| Content/Scope | Focus only on the method of analysis of a particular test | Prepared with the help of a standard test procedure and analytical control. Contains pharmaceutical details like tests, specifications, method of analysis, properties, use, safety, and storage conditions, etc |
| Usage | Analysis for R&D samples | Analysis and release of plant samples. Can be used for regulatory submission |
| Type | In-house | It may be In-house or pharmacopoeia (such as IP, BP, USP. etc) |
| Level of Details | High-level summary of accepted standards. | Very detailed and precise instructions for research samples analysis |
Standard test procedure(STP) and Analytical control/specification with test parameters are needed to prepare the monograph. Quality control experts prepare the monograph in coordination with quality assurance and analytical research experts
Include the following sections while writing a pharmaceutical 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 the organisation’s requirement.
Advantages
Example of a Pharmaceutical monograph
I hope this article has helped you understand the Pharmaceutical Monograph and its writing procedure.
Related:
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.
In-house monograph of any pharmaceutical, USP monograph, EP monograph, PP monograph and IP monograph
Indian pharmacopoeia monograph is used to perform analysis and manage the quality of the pharmaceuticals.
Analytical control and STP (standard test procedure) are used to write a drug monograph.
STP contains only test procedures, whereas a monograph contains test procedures, test parameters and specifications of any pharmaceutical.
References
Abbreviations
STP: standard test procedure
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Very worth knowledge for writing of monographs