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This short survey is intended to gather perspectives from regulatory authorities, pharmaceutical and biotechnology companies, contract laboratories, and subject matter experts on single-temperature incubation for Environmental Monitoring (EM) plates. The wording reflects a risk-based and validation-based approach consistent with EU GMP Annex 1, USP <1116>, and USP <1223>.

Estimated completion time: 5–7 minutes. Responses may be analyzed in aggregate to support industry benchmarking and discussion of validation, regulatory acceptance, and implementation expectations.

Regulatory framing
  • EU GMP Annex 1 principles support a science- and risk-based approach to incubation conditions, provided that scientific justification and data demonstrating equivalence to the established approach are available.
  • USP <1116> supports defining incubation conditions based on organisms expected in the manufacturing environment.
  • USP <1223> provides the general framework for validation of alternative microbiological methods and supports equivalence-based approaches.
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Section 1 — Respondent Profile
2.What type of organization are you from?
3.In what region is your organisation located?
4.What is your role?
Section 2 — Current Practices
5.Which EM sample types should be included in the assessment of a single-temperature incubation approach?
6.What is your current EM incubation approach?
7.What is your typical incubation temperature?
8.If dual-temp (Other than 20-25°C followed by 30-35°C) please specify here
9.What is your typical incubation duration?
Section 3 — Adoption & Drivers
10.What is the status of single-temperature incubation for EM samples?
11.What are the main drivers?
(select up to 3)
12.And what are the main barriers?
(select up to 3)
13.If organism recovery is of concern, please specify here
Section 4 — Regulatory Perspective Expectations and Acceptance
These questions may be answered by all respondents based on their experience or expectations regarding regulatory acceptance.
14.Is single-temperature incubation acceptable?
15.What is required for acceptance?
(select all that apply)
16.What is the expected regulatory approach?
Section 5 — Validation Expectations
The following questions are intended to capture respondents' views, experience, and expectations regarding validation requirements for single-temperature incubation. Please answer based on your knowledge and experience.
17.What are the required validation elements?
(select all that apply)
18.If equivalence study on Collection Strains only; if yes, please specify the rationale
19.If equivalence study on Collection Strains and local isolates, please specify which local isolates and rationale for selection
20.If specific micro-organism of concern (e.g. slow growers, micro-aerophilic, spore-formers, molds, other…), please specify
21.How important are local isolates?
Not important
2
3
4
Essential
22.What is the minimum incubation duration expectation?
Section 6 — Risk Perception

How comcerned are you about the following...
23.Reduced mold recovery
1 - Low concern
2
3
4
5 - High concern
24.Missing slow-growing organisms and spore-formers
1 - Low concern
2
3
4
5 - High concern
25.Regulatory rejection
1 - Low concern
2
3
4
5 - High concern
26.Loss of trend comparability
1 - Low concern
2
3
4
5 - High concern
27.What are the key mitigation measures?
(select up to 5)
Section 7 — Industry Benchmarking
28.How do you see industry’ readiness and inspection experience with single-temperature incubation
(select all that apply)
Section 8 — Operational Impact
29.What impact do you expect?
(select all that apply)
Section 9 — Overall Opinion
30.How would you rate the overall support for single-temperature incubation?
1 - Not supportive
2
3
4
5 - Fully supportive
31.Final comments / concerns
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