Defined compounding procedures are necessary to ensure that compounding activities, quality control and other relevant personnel are instructed on the details of the processes concerned.
General Instructions
1. The quantity of compounded medicine to be supplied should be in a unit of use for the individual.
2. Responsible Person should evaluate the dose, safety and intended use in term of the chemical and physical properties of the components, dosage forms and therapeutics appropriateness and route of administration. Calculations are performed to determine the quantities of the ingredients needed.
3. A compounding record should be completed each time a preparation is compounded.
4. Only one preparation should be compounded at one time in a specific workspace.
5. Equipment needs to be inspected for cleanliness and functions correctly before being use in the compounding process.
6. A reliable BUD is established before preparation to ensure safety and quality.
7. The preparation is made in accordance with international pharmacopoeias or references recognized by the Regulatory body.
8. Every critical process such as weighing, measuring or mixing has to be verified to ensure that compounded preparation is being prepared consistently according to the expected qualities.
9. The quality of final preparation is assessed (e.g. weight variation, adequacy of mixing, clarity, odor, color, consistency and pH) and this information is recorded in Compounding Records.
10. The preparation is packaged and labelled with necessary information in accordance with current law.
11. Cleaning of compounding area and all equipment should be done immediately after the preparation.
12. The Compounding Records should be reviewed to prevent errors and ensure that the preparation is suitable for use.
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Note: Compounding shall be specific for individual patient; thus the name of patient must be stated on the label of finished compounded preparations. Short name should be discouraged to prevent errors.
