Is Your Sterile Injectable Ready for Changes in Raw Materials?

In any manufacturing company, it is likely that raw material will change from time to time.  These changes are modifications in API synthesis, key starter materials and intermediates.  These changes are expected and necessary for manufacturing improvement.  The best approach to alternating materials from a supplier, is to always keep track and maintain data and drug integrity.

Changes in raw materials may occur when there are advances in manufacturing, availability of a product, finding an equivalent product that is less expensive or a change in manufacturing locations.  Any of these things will eventually happen at any manufacturing company, multiple instances.  It is important to keep track of these upgrades.

Pharmaceutical Online notes the importance of working with partnerships for materials, because they will make changes to products when needed.  It is necessary to conduct tests to make sure the material will work in replacement before accepting the new material.

InQuest Science’s Identifier software allows for tracking and trending all data that is entered into the system.  It allows for changes, additions and archives all data.  This makes for easier transitions when a new product or machine is replacing another.

Read the full article published by Pharmaceutical Online

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