Guidelines for Stability Testing of Parenteral Emulsions
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies on parenteral emulsions. Stability testing ensures that these emulsions maintain their safety, efficacy, and quality throughout their shelf life under various storage conditions.
2) Scope
This SOP applies to all parenteral emulsions, including lipid emulsions, intravenous nutritional products, and oil-based injectables, produced or handled by the organization. It is intended for personnel involved in formulation development, quality control, and regulatory affairs.
3) Responsibilities
Formulation Scientist: Responsible for designing the stability study protocol and selecting appropriate stability-indicating
Quality Control (QC) Team: Responsible for conducting stability tests according to the approved protocol and documenting results.
QA Team: Responsible for reviewing data, ensuring regulatory compliance, and approving the final stability report.
4) Procedure
4.1 Study Design:
- Identify stability-indicating parameters (e.g., droplet size distribution, zeta potential, sterility, and pH) relevant to the parenteral emulsion.
- Select appropriate analytical methods (e.g., Dynamic Light Scattering, Microscopy, pH measurement) to evaluate these parameters.
- Define storage conditions (e.g., room temperature, refrigerated) based on the product’s characteristics and regulatory guidelines.
- Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used.
4.2 Sample Preparation:
- Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under specified conditions.
4.3 Testing Schedule:
- Conduct initial testing on all samples to establish baseline data for the selected parameters.
- Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes in stability over time.
- Document all test results and analyze data for trends or deviations from acceptance criteria.
4.4 Data Analysis and Reporting:
- Analyze data using statistical methods to determine trends and compliance with acceptance criteria.
- Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling conditions.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Parenteral Emulsion Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
USP <729>: Globule Size Distribution in Lipid Injectable Emulsions
8) SOP Version
Version 1.0
Guidelines for Stability Testing of Protein Therapeutics
1) Purpose
The purpose of this SOP is to provide standardized procedures for conducting stability studies on protein therapeutics. Stability testing is essential to ensure that protein-based drugs maintain their safety, efficacy, and quality under various storage conditions throughout their shelf life.
2) Scope
This SOP applies to all protein therapeutics, including monoclonal antibodies, recombinant proteins, and fusion proteins, produced or handled by the organization. It is intended for personnel involved in formulation development, quality control, and regulatory compliance.
3) Responsibilities
Formulation Scientist: Responsible for designing the stability study protocol and selecting appropriate stability-indicating parameters.
Quality Control (QC) Team: Responsible for conducting stability tests according to the approved protocol and documenting results.
QA Team: Responsible for reviewing data, ensuring regulatory compliance, and approving the final stability report.
4) Procedure
4.1 Study Design:
- Identify stability-indicating parameters (e.g., potency, purity, aggregation, and degradation) relevant to the protein therapeutic.
- Select appropriate analytical methods (e.g., HPLC, SDS-PAGE, Mass Spectrometry) to evaluate these parameters.
- Define storage conditions (e.g., refrigerated, frozen) based on the product’s characteristics and regulatory guidelines.
- Develop a study protocol outlining the objectives, sampling schedule, and analytical methods to be used.
4.2 Sample Preparation:
- Prepare samples from representative production batches and label them with batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under specified conditions.
4.3 Testing Schedule:
- Conduct initial testing on all samples to establish baseline data for the selected parameters.
- Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes in stability over time.
- Document all test results and analyze data for trends or deviations from acceptance criteria.
4.4 Data Analysis and Reporting:
- Analyze data using appropriate statistical methods to determine trends and compliance with acceptance criteria.
- Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling conditions.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
SDS-PAGE: Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis
6) Documents, if any
Protein Therapeutic Stability Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
8) SOP Version
Version 1.0