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(FDA Guidance for Industry) (Excerpts)
November 2020
I. INTRODUCTION
II. BACKGROUND
III. POLICY
A. Examples of Insanitary Conditions
2. Insanitary Conditions Applicable to the Production of Sterile Drugs Only
- Gowning and Aseptic Practices (Covered in a previous newsletter.)
- Equipment/Facilities (Covered in last week's newsletter.)
- Sterilization
- Using a filter for the purposes of product sterilization that is not appropriately graded for sterilization, not appropriate for pharmaceutical use, or used in excess of its volume or pressure capacity
- Using a filter in drug production whose integrity is compromised; failing to conduct post-use filter-integrity testing on filters used to sterilize products
- Using a particle-shedding filter in any stage of sterile drug production
- Using parameters for sterilization (e.g., temperature, pressure, and time) that are not lethal to resistant microorganisms
- Cleaning and Disinfecting
- Using non-sterile disinfecting agents and cleaning pads/wipes in ISO-classified areas
- Lack of, improper, or infrequent use of a sporicidal agent in the facility's ISO 5 areas and other classified areas
- Failing to appropriately and regularly clean and disinfect (or sterilize) equipment located in the ISO 5 area
- Lack of disinfection of equipment and/or supplies at each transition from areas of lower quality air to areas of higher quality (e.g., from non-classified to first classified room, from anteroom to buffer room, from buffer room to ISO 5 area)
- Using disinfectant in a manner insufficient to achieve adequate levels of disinfection (e.g., using insufficient disinfectant contact time (also known as "dwell time"), concentration, or coverage of the item/surface being disinfected)
- Using sterile cleaning and disinfecting agents past their expiry date or "discard after opening" date
- Using cleaning and disinfecting agents that may leave residues or not adequately rinsing such agents from containers, closures, or equipment that come into direct contact with drugs
- Other Insanitary Conditions
- Allowing operators with topical or respiratory infections or with open wounds to work within compounding operations
- Compounding with components, containers (e.g., in-process or finished), or other materials that have not been verified to assure that they do not contribute endotoxin contamination that may be objectionable given the product's intended use
- Compounding under processing conditions that offer insufficient assurance that the finished product will meet an endotoxin specification appropriate for its route of administration
- Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging and stressful conditions
[To be completed next week.]
III. POLICY
A. Examples of Insanitary Conditions
1. Insanitary Conditions Applicable to the Production of Sterile and Non-Sterile Drugs
2. Insanitary Conditions Applicable to the Production of Sterile Drugs Only
- Gowning and Aseptic Practices
- Equipment/Facilities
- Sterilization
- Cleaning and Disinfecting
- Other Insanitary Conditions
B. Preventative and Corrective Actions for Insanitary Conditions
C. Regulatory Action
PLEASE NOTE THAT THESE ARE EXCERPTS ONLY AND THE ENTIRE DOCUMENT SHOULD BE OBTAINED AT THE LINK BELOW AND READ.
Insanitary Conditions at Compounding Facilities (fda.gov)
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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