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Good manufacturing practices and clinical supplies.
1Food and Drug Administration, Rockville, Maryland.
Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|May 1, 1991
Summary
Ensuring drug product quality requires adherence to good manufacturing practices (GMP) for both investigational and commercial use. New guidelines will clarify GMP compliance for clinical supplies, focusing on sterile parenteral products.
Area of Science:
- Pharmaceutical Manufacturing and Quality Control
- Clinical Trial Supply Chain Management
Background:
- Maintaining quality characteristics is crucial for investigational and commercial drug products.
- Good Manufacturing Practices (GMP) are essential for the production, control, and testing of pharmaceuticals.
Framework:
- A forthcoming guideline addresses acceptable practices for preparing investigational new drug products.
- This guideline aims to facilitate compliance with current GMP (CGMP) regulations for clinical supplies.
Implementation:
- Inspections of sterile clinical supplies production will focus on factors influencing safety, quality, and uniformity.
- Key areas for parenteral clinical supplies include validation of terminal sterilization, aseptic processing, and oxygen exclusion.
- Special attention is required for validating aseptic handling during lyophilization.
Implications:
- Adherence to CGMP ensures product safety and efficacy for clinical trials.
- Other CGMP considerations include establishing a quality control unit and preventing packaging mix-ups.
- Manufacturers should prepare for potential amendments to CGMP regulations concerning terminal sterilization.