Standard Operating Procedure for Formulation Development of Intramuscular (IM) and Subcutaneous (SC) Injections
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for the formulation development of Intramuscular (IM) and Subcutaneous (SC) injections to ensure that the final product is safe, effective, and stable.
2) Scope
This SOP applies to all formulation scientists and development personnel involved in the formulation development of IM and SC injections within the pharmaceutical manufacturing facility.
3) Responsibilities
– Formulation Development Team: Responsible for designing and optimizing formulations for IM and SC injections.
– Analytical Development Team: Responsible for developing and validating analytical methods to test the formulations.
– Quality Assurance (QA) Department: Ensures compliance with regulatory guidelines throughout the development process.
– Regulatory Affairs: Ensures the formulation complies with all regulatory requirements.
4) Procedure
4.1 Pre-formulation Studies
4.1.1 Conduct literature research to gather information on the physicochemical properties of the active pharmaceutical ingredient (API).
4.1.2 Perform solubility studies to determine the best solvents and excipients.
4.1.3 Evaluate the compatibility of the API with various excipients.
4.2 Formulation Design
4.2.1 Develop initial formulation prototypes based on pre-formulation studies.
4.2.2 Select appropriate excipients considering factors like solubility, stability, and patient
4.2.3 Prepare small-scale batches of the formulation for preliminary evaluation.
4.3 Analytical Method Development
4.3.1 Develop and validate analytical methods to assess the quality of the formulation.
4.3.2 Conduct assays for potency, degradation products, and other critical quality attributes.
4.4 Optimization and Scale-up
4.4.1 Optimize the formulation through iterative testing and modification based on stability and efficacy data.
4.4.2 Scale up the formulation from laboratory to pilot plant scale while maintaining quality and consistency.
4.4.3 Conduct pilot-scale batches and evaluate their performance compared to the small-scale batches.
4.5 Stability Studies
4.5.1 Conduct accelerated and long-term stability studies on the optimized formulation.
4.5.2 Analyze stability data to confirm the formulation’s shelf life and storage conditions.
4.6 Documentation and Reporting
4.6.1 Document all formulation development activities, including protocols, batch records, and test results.
4.6.2 Prepare comprehensive formulation development reports summarizing the research, testing, and conclusions.
4.6.3 Submit reports to the QA department for review and approval.
4.7 Regulatory Submission
4.7.1 Compile all necessary data and documentation for regulatory submissions.
4.7.2 Ensure the formulation meets all regulatory guidelines and requirements.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– API: Active Pharmaceutical Ingredient
– QA: Quality Assurance
6) Documents, if any
– Formulation Development Protocols
– Batch Records
– Analytical Method Validation Reports
– Stability Study Reports
7) Reference, if any
– ICH Q8(R2): Pharmaceutical Development
– FDA Guidance for Industry: Q8(R2) Pharmaceutical Development
8) SOP Version
Version 1.0
