Standard Operating Procedure for Preparing Lyophilized Formulations for Pediatrics
1) Purpose
This SOP outlines the procedure for preparing lyophilized formulations for pediatric use, ensuring safety, palatability, and ease of administration.
2) Scope
This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized products designed for pediatric patients, including formulation scientists, production operators, and QA personnel.
3) Responsibilities
- Formulation Scientists: Responsible for designing formulations suitable for pediatric use, ensuring safety, taste-masking, and age-appropriate excipients.
- Operators: Responsible for preparing the pediatric formulation as outlined in the Batch Manufacturing Record (BMR).
- QA: Responsible for verifying the safety, taste, and documentation of the pediatric formulation.
4) Procedure
4.1 Pediatric Formulation Design
4.1.1 Criteria for Pediatric Formulations
- 4.1.1.1 The formulation must be safe for pediatric use, with carefully selected excipients that are non-toxic and palatable for children.
- 4.1.1.2 Taste-masking agents or sweeteners may be added to improve the taste, making the formulation more acceptable for young patients.
4.2 Preparation and Lyophilization
4.2.1 Solution Preparation
- 4.2.1.1 Weigh the active ingredients and excipients as per the BMR.
- 4.2.1.2 Dissolve the ingredients in a suitable solvent, ensuring homogeneity and palatability.
4.2.2 Filling and Lyophilization
- 4.2.2.1 Fill the solution into appropriate pediatric-friendly containers and freeze before lyophilization.
- 4.2.2.2 Run the lyophilization cycle as per the BMR, ensuring the final product is suitable for pediatric use.
4.3 Testing for Pediatric Use
- 4.3.1 After lyophilization, test the formulation for safety, taste, and ease of reconstitution to ensure it meets pediatric standards.
4.4 Documentation
Record all steps in the Pediatric Lyophilized Formulation Logbook, ensuring that QA verifies the safety, taste-masking, and other test results.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Pediatric Lyophilized Formulation Logbook
7) References
- Pharmacopoeial guidelines for pediatric formulations and safety testing
8) SOP Version
Version 1.0
Annexure
Pediatric Lyophilized Formulation Logbook Template
| Date | Formulation Name | Batch No. | Taste-Masking Test | Safety Test | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Batch Number | Pass/Fail | Pass/Fail | Operator Name | QA Initials |