Ensuring products are contaminant-free is necessary for patient safety and drug efficacy, as contamination causes adverse effects on patient health and outcomes. Additionally, contamination can
Pharmaceutical compliance issues and observations have been at an all-time high in recent years. However, the best time to comply with all quality policies is
Recently, the FDA has been providing much heavier guidance – and more Form 483s for objectionable conditions – with respect to the regulatory requirements of
At MediZap, we prioritize Quality by Design (QbD) principles in pharmaceutical manufacturing to ensure our clients’ products meet stringent quality standards and regulatory compliance. By
This article discusses the FDA’s role in regulating compounding pharmacies, focusing on the implications of receiving FDA Form 483 observations and warning letters during inspections.
Learn more about ISO, and how partnering with MediZap can ensure compliance with ISO standards, and regulatory protocols, including those set by the FDA and
Revisions to the USP General Chapter 797 Regulations, published in 2022 by the Compounding Expert Committee of the US Pharmacopeia Convention, include updates on compounding
E-Beam and X-Ray sterilization, with its superior penetration characteristics, processing flexibility, and regulatory acceptance, emerges as an advantageous method for terminal sterilization of dense drug
Learn how terminal sterilization by irradiation of ophthalmic solutions delivers the most safe and effective sterile drug preparations as compared to aseptic fill/finish by filtration.