Learn how to write a compliant General Test Procedure (GTP) SOP for analysis with structure, tips & GMP guidelines.
Introduction
In pharmaceutical quality control, consistency and clarity in analytical testing are critical. A well-documented General Test Procedure (GTP) ensures that every analyst follows the same steps, minimizing variability and ensuring compliance with GMP standards.
This SOP provides a structured method for preparing, reviewing, approving, and controlling GTP documents, ensuring uniformity across all laboratory analyses.
1.0 OBJECTIVE
To establish a procedure for the preparation, approval, authorization, control, and revision of General Test Procedures (GTP) to ensure uniformity in analytical practices.
2.0 SCOPE
This SOP applies to all General Test Procedures prepared by the Quality Control (QC) Department.
3.0 RESPONSIBILITY
3.1 Doing
- Technical Assistant / Executive
3.2 Checking
- Executive / Manager
4.0 ACCOUNTABILITY
- Head of Department
5.0 PROCEDURE
5.1 Overview of GTP Documentation
A General Test Procedure (GTP) is a standardized analytical method document that outlines step-by-step testing instructions to ensure:
- Accuracy
- Reproducibility
- Compliance
5.2 Step-by-Step SOP
How to Write a General Test Procedure (GTP)
- Use the approved GTP format.
- Clearly define the test name and type in the heading.
- Write the objective of the test.
- List all chemicals and reagents required.
- Describe the procedure step-by-step.
- Ensure clarity and simplicity in instructions.
- Submit for review and approval.
- Control and maintain document versions.
5.3 Preparation of General Test Procedure
- Draft GTP using approved format template
- Ensure consistency with regulatory guidelines
- Use clear, concise, and unambiguous language
5.4 Structuring the GTP Document
Each GTP must include the following sections:
a. Objective
- Define purpose of the test
- Mention expected outcome
b. Chemicals and Reagents
- List all required materials
- Include grade/specification (e.g., AR, LR)
c. Procedure
- Stepwise instructions
- Include:
- Sample preparation
- Instrument parameters
- Observations and calculations
5.5 Writing Analytical Procedures Effectively
- Use step-by-step instructions
- Avoid complex sentences
- Include critical control points
- Specify acceptance criteria where applicable
5.6 Review and Approval Process
- Prepared by: QC personnel
- Checked by: Manager/Executive
- Approved by: Head of Department
5.7 Document Control and Revision
- Assign document number and version
- Maintain revision history
- Update GTP when:
- Method changes
- Regulatory updates occur
- Deviations are observed
6.0 ABBREVIATIONS
| Abbreviation | Meaning |
|---|---|
| GTP | General Test Procedure |
| QC | Quality Control |
Safety & Compliance Tips
- Always follow laboratory safety protocols
- Use properly calibrated instruments
- Wear PPE (gloves, lab coat, goggles)
- Document deviations immediately
- Ensure compliance with GMP guidelines
Common Mistakes to Avoid
- ❌ Writing vague or unclear steps
- ❌ Missing reagent specifications
- ❌ Lack of version control
- ❌ Skipping approval process
- ❌ Not updating outdated procedures
Best Practices for GTP Writing
- Use simple and precise language
- Maintain consistent formatting
- Include diagrams or references if needed
- Validate procedures before implementation
- Train staff on new/revised GTPs
FAQs
1. What is a General Test Procedure (GTP)?
A GTP is a standardized document describing analytical test methods in QC labs.
2. Why is GTP important in pharmaceuticals?
It ensures consistency, accuracy, and regulatory compliance.
3. Who prepares the GTP?
Technical Assistant or QC Executive.
4. What are key sections of a GTP?
Objective, Chemicals & Reagents, and Procedure.
5. How often should GTP be revised?
Whenever there are changes in method, equipment, or regulations.
6. What is the difference between GTP and SOP?
GTP focuses on testing methods; SOP covers broader procedures.
7. Can GTP include instrument parameters?
Yes, it should include all relevant analytical details.
8. What happens if a GTP is not followed?
It may lead to inaccurate results and compliance issues.
9. How to ensure GTP compliance?
Through training, audits, and proper documentation control.
10. Is validation required for GTP?
Yes, analytical methods should be validated before use.