Ensuring the safety and quality of injectable drugs requires rigorous standards in facility design, equipment selection, and inspection processes. This guide explores the key cGMP requirements that help manufacturers prevent contamination and detect particulates, safeguarding patient health through meticulous quality control.
FDA Injectable Drug Recall Notices: Interactive Chart
Ensuring compliance with Section 501 of the FD&C Act is vital for maintaining the safety, quality, and efficacy of pharmaceutical products. Strict adherence to environmental controls, validated procedures, and official standards prevents product adulteration and protects patient health.
Injectable products are a type of pharmaceutical formulation designed to be administered directly into the body through a needle. This approach allows the medication to bypass the digestive tract.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
Par Pharmaceutical, Inc. has voluntarily recalled one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product was recalled due to the potential for the presence of silicone particulates in the product solution.
The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection.
Injectable products contaminated with visible particulates, such as glass or rubber, can cause severe complications including inflammation, tissue damage...
Ensuring compliance with Section 501 of the FD&C Act is vital for maintaining the safety, quality, and efficacy of...
Properly designed defect test sets are essential for qualifying inspectors in pharmaceutical visual inspection. This post explores the optimal...
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