Guidelines for Stability Testing of Drugs in Pre-Filled Syringes
1) Purpose
The purpose of this SOP is to outline the procedures for conducting stability studies on drugs stored in pre-filled syringes. Stability studies ensure that drugs maintain their safety, potency, and quality throughout their shelf life, considering the unique packaging and delivery system of pre-filled syringes.
2) Scope
This SOP applies to all drugs formulated and packaged in pre-filled syringes by the organization, including biologics, vaccines, and parenteral medications. It is intended for use by personnel involved in formulation development, quality control, and regulatory affairs.
3)
Formulation Scientist: Responsible for designing the stability study protocol.
Quality Control (QC) Team: Responsible for conducting the required tests and documenting results.
QA Team: Responsible for reviewing data, ensuring compliance, and approving the final report.
4) Procedure
4.1 Study Design:
- Select appropriate stability-indicating parameters, such as appearance, extractables and leachables, sterility, and potency.
- Define the storage conditions (e.g., temperature, humidity) to be tested based on the drug’s intended use and regulatory guidelines.
- Develop a study protocol that includes the sampling schedule, analytical methods, and acceptance criteria.
4.2 Sample Preparation:
- Prepare samples from representative batches of the drug filled in syringes according to standard procedures.
- Label samples with relevant information, including batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under the specified conditions.
4.3 Testing Schedule:
- Perform initial testing to establish baseline data for all parameters.
- Conduct stability tests at predetermined intervals to monitor changes over time.
- Record all test results and analyze data for trends or deviations from the acceptance criteria.
4.4 Data Analysis and Reporting:
- Compile data and evaluate if the product meets the defined criteria for each time point.
- Prepare a report summarizing the stability study findings, conclusions, and recommended storage conditions.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Pre-Filled Syringe 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 <781>: Plastic Packaging Systems and Their Materials of Construction
8) SOP Version
Version 1.0