StabilityStudies.in

SOP for Evaluating Stability for Drugs in Aseptic Processing

Standard Operating Procedure for Stability Testing of Drugs Manufactured in Aseptic Conditions

1) Purpose

This SOP aims to establish a procedure for conducting stability studies on drugs manufactured under aseptic conditions. The purpose is to ensure that these drugs maintain their sterility, potency, and efficacy throughout their shelf life.

2) Scope

This SOP is applicable to all drugs manufactured using aseptic processing techniques. It includes all teams involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Responsible for performing sterility and stability tests.
Quality Assurance (QA) Team: Ensures that the stability studies

comply with this SOP and regulatory guidelines.

Production Team: Prepares the samples according to aseptic processing requirements.

4) Procedure

Preparation of Samples
1. Collect samples from batches produced under aseptic conditions.
2. Ensure all samples are handled under aseptic conditions to maintain sterility.
Design of Stability
“Ensuring Pharmaceutical Purity and Potency: Unveiling Effective Techniques for Reliable Stability Testing and Quality Control”
Study
1. Draft a protocol specifying storage conditions, test intervals, and required tests (e.g., sterility, potency).
2. Obtain approvals from the QA and Regulatory Affairs teams.
Conducting Stability Testing
1. Store samples in stability chambers under controlled conditions (e.g., 25°C/60% RH).
2. Perform stability tests at each specified interval, including sterility, potency, and physical examination.
3. Document all findings and any deviations from the protocol.
Data Analysis and Interpretation
1. Evaluate the data to assess whether the product meets sterility and stability requirements.
2. Prepare a comprehensive report and submit it to the QA team for review.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
RH: Relative Humidity

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products
FDA Guidance for Aseptic Processing

8) SOP Version

Version 1.0