Quality review of sterile hospital preparations: a recommendation of Good Preparation Practices

Introduction
The implementation of quality reviews for preparations is a recommendation of Good Manufacturing Practices. Quality reviews of sterile pharmaceutical preparations were conducted, focusing on a neonatal rehydration injectable solution "AP ISO" produced through a sterile preparation process under laminar flow in a 50 mL autoclaveable vial, and on a sterile solution of fructose (5%) 12.5 g - glycerol (10%) 25 g - 250 mL produced through a sterile preparation process under laminar flow in a bag.

Material et method
Data collection was carried out for all batches produced in 2023, including the raw materials and packaging materials used for preparation, the results of in-process controls (number of airborne particles, microbiological air contamination, surface microbiological contamination, filter integrity, production yield, number of units failing visual inspection), the results of quality controls on the finished product (pH, osmolality, sodium, glucose, chloride, 5HMF content, number of non-visible particles, endotoxin content, sterility), as well as the tracking of changes and complaints.

Results
Regarding the neonatal rehydration injectable solution "AP ISO," 14 batches were produced in 2023, of which 2 batches were destroyed. Out of 4600 planned units, 4483 units were produced (97.5%), and 3212 units were released (69.8%). The deviations found in this preparation included: non-compliant autoclave cycle, glass breakage detected during visual inspection, and broken vials affecting production yield. An increase in the number of units per batch was implemented during the year. All other analyzed parameters showed no deviations.
For the sterile fructose (5%) 12.5 g - glycerol (10%) 25 g - 250 mL solution, 13 batches were produced in 2023, of which 1 batch was destroyed. Out of 1560 planned units, 1560 units were produced (100.0%), and 1080 units were released (69.2%). The deviations found in this preparation included: non-compliant osmolality and sodium content values in one batch, and non-compliant glycerol content in 5 batches (external analysis). All other analyzed parameters showed no deviations.

Conclusion
These reviews help identify improvements to be made to the products and processes. An improvement action needs to be implemented regarding the storage of vials during depyrogenation and sterilization steps to prevent vial breakage. The glycerol content analysis has been internalized. Additionally, the measurement of acrolein, an aldehyde produced by the thermal degradation of glycerol, should be added to the quality control of the sterile fructose (5%) 12.5 g - glycerol (10%) 25 g - 250 mL solutions.

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