Injectable drug products need to have an extreme and successful sterile fill to finish.
How do you ensure your manufacturers obtain the highest level of operational and quality excellence?
Manufacturing environments must be tightly controlled—especially due to the increase in demand of sterile injectables. Qualifying every part of the product leading up to the final product is a must. To achieve best results, every vial, stopper, syringe, excipient and API needs an inspection process. It is important to ensure that every product works in the manufacturing facilities, as well as outside of that setting.
Risks are magnified in sterile injectables. It is important to evaluate each part and acknowledge the potential risks that could occur—especially if working with high potent APIs and other fragile components.
Having complete transparency between partners is important. Such as the length of production, the raw data throughout production and any other piece of information found from fill to finish.
Collaborate with known companies who you can trust. Expert companies ensure a higher quality of products being given to your manufacturing facilities.
With InQuest Science’s Identifier Software, you track and trace all data from fill to finish. Ensure all parts and products are sterile and stay sterile. Data is imported into our software—leading you to save time on paperwork. Having an organized process laid out right in front of you, will help your manufacturing facilities feel more confident on producing large orders of sterile injectables.
Read the full article here, published by Pharmaceutical Online