and verify the formulation process, ensuring compliance with quality standards and regulatory requirements. Monitor the documentation and record-keeping process.

Regulatory Affairs Personnel: Ensure that screening formulations are prepared in compliance with relevant regulations and guidelines for preclinical studies.

4) Procedure

The following steps outline the procedure for preparing screening formulations:

1. Step 1: Define Formulation Requirements
   1. Review the study protocol and identify the required composition of the screening formulation, including the active pharmaceutical ingredient (API), excipients, and desired dosage form (e.g., solution, suspension, tablet).
   2. Determine the appropriate concentration, pH, viscosity, and other physical characteristics of the formulation required for the screening assays.
   3. Consult with toxicology, pharmacokinetics, and pharmacodynamics teams to ensure that the formulation meets the study objectives and regulatory requirements.
2. Step 2: Selection of Ingredients
   1. Choose high-quality ingredients that meet the necessary standards for purity, stability, and compatibility. This includes selecting the correct API and excipients such as binders, fillers, preservatives, and solvents.
   2. Ensure that the selected excipients are appropriate for the intended dosage form and do not interfere with the stability or efficacy of the API.
   3. Check that all ingredients are available in the required quantities and are free from contamination.
3. Step 3: Formulation Preparation
   1. Prepare the formulation by accurately weighing the API and excipients according to the defined formulation requirements. Ensure that the preparation process is conducted in a clean and controlled environment to avoid contamination.
   2. Follow established procedures for the preparation of each dosage form, including mixing, dissolution, and homogenization techniques to ensure uniformity.
   3. For liquid formulations, ensure that the API is dissolved completely and that the formulation is homogeneous.
   4. For solid dosage forms, ensure that the components are properly blended and that the formulation is uniform throughout.
4. Step 4: Quality Control Checks
   1. Perform quality control tests to verify that the screening formulation meets the defined specifications. These may include checking the appearance, pH, viscosity, particle size distribution, and API content.
   2. Ensure that the formulation is stable under the intended storage conditions. Conduct stability testing as necessary to confirm the formulation’s shelf life.
   3. Conduct homogeneity tests to ensure that the API is evenly distributed throughout the formulation.
5. Step 5: Packaging and Labeling
   1. Package the screening formulation in suitable containers that protect the formulation from light, moisture, and contamination.
   2. Label each container with relevant information, including the formulation composition, batch number, preparation date, and expiration date.
   3. Ensure that all labeling complies with study requirements and regulatory guidelines.
6. Step 6: Documentation and Record Keeping
   1. Document the preparation process, including batch numbers, ingredient quantities, preparation methods, quality control results, and any deviations from the protocol.
   2. Ensure that all records are complete, accurate, and legible. Maintain records according to regulatory requirements and internal quality standards.
   3. Ensure that all deviations from the standard procedure are documented, along with the rationale for any changes or adjustments.
7. Step 7: Storage and Distribution
   1. Store the prepared screening formulations under the required conditions (e.g., refrigeration, room temperature) to maintain stability and potency.
   2. Ensure that the formulations are stored in a controlled environment, with clear labeling and appropriate tracking for future use.
   3. Distribute the formulations to the relevant departments or study groups, ensuring proper documentation and chain of custody.
8. Step 8: Sample Disposal
   1. Ensure that any leftover screening formulation materials are disposed of according to biosafety and waste disposal regulations.
   2. Dispose of hazardous materials in designated biohazard or chemical waste containers to minimize environmental impact.

5) Documents

The following documents should be maintained during the preparation of screening formulations:

1. Formulation Protocols
2. Ingredient Logs
3. Preparation Records
4. Quality Control Records
5. Packaging and Labeling Records
6. Stability and Homogeneity Data
7. Deviation and Corrective Action Records

6) Abbreviations

• API: Active Pharmaceutical Ingredient
• QA: Quality Assurance
• GLP: Good Laboratory Practices
• HPLC: High-Performance Liquid Chromatography

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• OECD Guidelines for Good Laboratory Practice (GLP)
• FDA Guidelines for Drug Formulation
• ICH Q6A Specifications for Drug Substances and Drug Products

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Screening Formulation Preparation Log

Batch ID	Formulation Type	API Concentration	Preparation Date	QC Results	Storage Conditions