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(FDA Guidance for Industry) (Excerpts)
November 2020
I. INTRODUCTION
II. BACKGROUND
III. POLICY
- Examples of Insanitary Conditions
Section III.A of this guidance provides examples of conditions that FDA has observed at one or more compounding facilities it has inspected and considers to be insanitary conditions.
Section III.B of this guidance describes corrective actions that compounding facilities should take when they identify insanitary conditions. It also describes actions that are recommended to prevent the occurrence of insanitary conditions
Finally, Section III.C of this guidance discusses regulatory actions FDA may take in response to insanitary conditions we identify at a compounding facility.
A. Examples of Insanitary Conditions
Although product sterility is not a requirement for non-sterile drugs, it is possible for non-sterile drugs to become contaminated with microorganisms of a type or at a level that can cause patient harm. Non-sterile aqueous solutions are particularly susceptible to microbial growth if contaminated. Contamination may also include non-viable filth and the presence of unintended drug components.
The following are examples of insanitary conditions that have been observed and are applicable to both sterile and non-sterile drug production and applicable to the production of sterile drugs only. These examples do not constitute an exhaustive list.
1. Insanitary Conditions Applicable to the Production of Sterile and Non-Sterile Drugs
- Vermin (e.g., insects, rodents) or other animals (e.g., dogs) or evidence of their presence (e.g., urine, feces) in the production area or adjacent areas
- Visible microbial contamination (e.g., bacteria, mold) in the production area or adjacent areas
- Foreign matter in the production area (e.g., rust, glass shavings, hairs, paint chips)
- Producing drugs while construction is underway in a nearby area without adequate controls to prevent contamination of the production area and product
- Standing water or evidence of water leakage in the production area or adjacent areas
- Handling bulk drug substances or drug products that are hazardous, sensitizing, or highly potent (e.g., hormones) with inadequate controls to prevent cross-contamination. This includes:
- inadequate dedication, segregation, and containment (e.g., a powder-containment hood) of a suite, room, or piece of equipment based on risk;
- inadequate cleaning of rooms, work surfaces, and equipment (e.g., utensils), including spills;
- inadequate segregation of HVAC systems (as appropriate for the operation); and
- inadequate control over the movement of personnel and materials
- Processing of beta-lactams without complete and comprehensive separation from non-beta-lactam products
- Using active ingredients, inactive ingredients, or processing aides that have or may have higher levels of impurities compared to compendial or pharmaceutical grade equivalents (e.g., ingredients with potentially harmful impurities, ingredients labeled with "not for pharmaceutical use" or an equivalent statement)
[Continued next week.]
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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