Pharmaceuticals

Question

1. Scenario: A doctor is about to inject an aseptically manufactured injectable finished pharmaceutical into the arm of a child. 

1. How would you convince both the patient’s parents and the doctor that the manufacturing process was robust and to proceed in confidence with administration? 
2. What are the biggest risks to the child? 
3. How are they controlled? 

 

I dont need a massive 2 page answer but a reasonable short answer

Answer 1

1. Verify that the product is manufactured in an FDA Approved facility following CGMP guidelines, along with a facility that is following USP sterile compounding guidelines. In short, adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. USP has a stringent set of guidelines on sterile environments and aseptic technique (USP 795, 797, and 800).
2. Biggest risks would include adverse reactions (allergic reactions including injection site reactions and anaphylaxis), depending on the injectable drug possible side effects, and infection.
3. I'm not sure what you mean by controlled but these facilities are audited randomly by multiple different agencies each year to ensure compliance.