Description
The former regulations at 21 CFR 600.11(e)(3) (§ 600.11(e)(3)) required that all work with spore-bearing microorganisms (spore-formers) be conducted in an entirely separate building, or in a completely walled-off portion of a multiproduct building. This isolated building had to be dedicated exclusively for the manufacturing or storage of spore-formers.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4Manufacturing biological intermediates using spore-forming microorganisms; manufacture, processing, packing or holding of drugs, including biological intermediates
Manufacturing biological drug substances using spore-forming microorganisms; manufacture, processing, packing or holding of drugs, including biological drug substances
Finished dosage form containing an active biological drug ingredient.
Extrapolation rules for well characterised biologicals; Less amenable to modelling by humidity modified Arrhenius equation
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Regulatory Activities
1Process of closing a dedicated spore-former manufacturing area.
Document Types
1SOPs describing the manufacturing process for CSP
Attributes
3Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
The processing point where viable organisms are not part of the process
Analytical procedure validation characteristic
Technical Details
Substances
5Organisms capable of spore production used in manufacturing; guidance does not apply to spore-forming microorganisms used for supplemental sterilization procedure control tests; The primary biological agent requiring containment and decontamination.
Organisms that are capable of spore production, including both spore and vegetative forms
Alternatives for second-generation vaccines
Substance used for sanitizing.
CAS# 7722-84-1; Chemical inducing oxidative stress; PDE of 68,000 µg/day based on endogenous production; Hydrogen peroxide (CAS# 7722-84-1) potential for human exposure and mutagenicity; Compound-specific acceptable intake calculation for hydrogen peroxide
Testing Methods
2Used to determine frequency of filter changes; Guidelines for Listeria testing of environmental samples
Method recommended for developing the number of samples for testing.
Processes
6implied manufacturing process under QS regulation
A process that eliminates or inactivates viable bioburden and any associated toxic material
Required for contaminated equipment and media before disposal
Basic specimen manipulation step
utilizing a decontamination chamber system such as an autoclave, sterilize-in-place (SIP) cycle
The process of cleaning and decontaminating an area between different products.
Clinical Concepts
1Example of a disease condition where route of exposure affects progression
Identified Hazards
Hazards
1Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Related CFR Sections (2)
- 21CFR600.11§ 600.11 Physical establishment, equipment, animals, and care.
(a) Work areas. All rooms and work areas where products are manufactured or stored shall be kept orderly, clean, and free of dirt, dust, vermin and objects not required for manufacturing. Precautions shall be taken to avoid clogging and back-siphonage of drainage systems. Precautions shall be taken Read full regulation →
- 21CFR600.10§ 600.10 Personnel.
(a) [Reserved]Read full regulation →
See Also (8)
- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products (Status: Final)
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry (Status: Final)
- PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline (Status: Final)
- Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry (Status: Final)
- Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Guidance for Industry (Status: Final)
- Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry (Status: Final)