This is a ready-to-use form for determining whether a recovered organism is objectionable in the context of a specific product. The determination is risk-based and product-specific, not a fixed list, so the form captures the inputs and the reasoning rather than a lookup. Replace every <<FILL: ...>> placeholder, attach it to the governing investigation, and route it through your normal review and approval. Field definitions and a filled specimen follow. This content is educational reference, not legal or regulatory advice.
Form header
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Form number | <<FILL: OOD-ID>> | Yes | Author | At raise |
| Investigation / deviation reference | text | Yes | Author | At raise |
| Organism (final identification) | text | Yes | Micro SME | After ID |
| Identification level and record ref | text | Yes | Micro SME | After ID |
| Product / material affected | text | Yes | Author | At raise |
| Date | date | Yes | Author | At raise |
1. Product and context inputs
| Input | Entry |
|---|---|
| Product type | <<FILL: sterile injectable / inhalation / topical / nonsterile oral / API / other>> |
| Route of administration | <<FILL>> |
| Patient population | <<FILL: general / paediatric / immunocompromised / other>> |
| Preservative system | <<FILL: present and type, or none>> |
| Manufacturing context | <<FILL: aseptic fill / terminal sterilization / nonsterile, plus area/grade of recovery>> |
| Numeric limit status | <<FILL: within / exceeds bioburden or EM limit>> |
2. Organism risk drivers
| Driver | Assessment |
|---|---|
| Route and population sensitivity | <<FILL>> |
| Pathogenicity / toxin (e.g. endotoxin for Gram-negatives) | <<FILL>> |
| Ability to survive or grow in the product / resist the preservative | <<FILL>> |
| Source significance (e.g. waterborne Gram-negative near a sterile fill) | <<FILL>> |
| Recognized association with recalls / patient harm | <<FILL>> |
3. Determination
| Field | Entry |
|---|---|
| Objectionable for this product/context? | Yes / No |
| Reasoning | <<FILL: tie the determination to the drivers above>> |
| Critical-zone rule applied (sterile) | <<FILL: for sterile critical zones, any recovered organism is treated as significant>> |
| Decision authority | Micro SME and QA |
4. Product-impact and onward actions
| Field | Entry |
|---|---|
| Batch impact assessment reference | <<FILL>> |
| Disposition input | <<FILL: how this determination feeds disposition>> |
| Water system / preservative review triggered | Yes / No, <<FILL>> |
| Recall / field-action evaluation triggered | Yes / No, <<FILL>> |
| Watch-list update | <<FILL: added to organisms-of-concern list?>> |
5. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Micro SME | <<FILL>> | ||
| QA | <<FILL>> |
QA must engage with the reasoning and the disposition input, not just sign; the determination drives whether product is at risk.
Field definitions
- Objectionable organism: one that, given the product, route, population, and context, poses a risk to product quality or patient safety. The concept comes from 21 CFR 211.113 and is developed in USP <1111> and <62>. It is risk-based and product-specific.
- Critical-zone rule: for sterile products made aseptically, any organism recovered in the critical zone is treated as significant and fully investigated, regardless of any “pathogen” list.
- Numeric limit status: meeting a numeric bioburden limit does not end the inquiry; the identity can still make the organism objectionable.
Retention
Retain with the governing investigation for not less than <<FILL: retention period>>. The reasoned determination is the record an inspector traces when asking why an in-limit count was, or was not, escalated.
Filled specimen
The following shows the form completed for an example nonsterile oral liquid. Numbers and organisms are illustrative.
Form: OOD-2026-018. Investigation: DEV-2026-0207. Organism: Burkholderia cepacia complex (species-level, ID-2026-0809). Product: nonsterile oral liquid, aqueous.
| Input | Entry |
|---|---|
| Product type / route / population | Nonsterile aqueous oral liquid; oral; general including potentially vulnerable users |
| Preservative system | Present; the organism is known to resist some preservative systems |
| Numeric limit status | Within the numeric bioburden limit |
| Route/population sensitivity | Moderate orally, but the organism is a recognized concern for aqueous products |
| Pathogenicity / survival | Survives in water, resists some preservatives, associated with recalls of contaminated aqueous products |
| Source significance | Points to the water system and preservative efficacy |
Determination: Objectionable in this context, despite the count being within the numeric limit. Reasoning: Burkholderia cepacia complex is a recognized objectionable organism for nonsterile aqueous products because of its water survival, preservative resistance, and recall history; the numeric limit being met does not change that. Actions: batch impact assessment raised; water system and preservative-efficacy review triggered; organism added to the facility watch list; QA and Micro SME approved.
The point this specimen makes: the numeric limit was met, and a count-only program would have released the batch. The identity, not the count, drove the escalation. That is exactly the determination this form exists to force.
Common inspection findings this form prevents
- An objectionable-organism assessment skipped for nonsterile product because the count was within the numeric limit, missing a waterborne pathogen.
- A determination made by micro alone with no QA engagement on product impact.
- A “not objectionable” conclusion asserted with no reasoning tied to route, population, survival, or source.
- A sterile critical-zone recovery treated as acceptable because it was not on a pathogen list.
How to adapt this form
- Set your form numbering and link it to your deviation system.
- Replace the driver list in section 2 with any additional inputs your products require.
- Maintain a facility watch list of organisms of concern and feed it from section 4.
- Make QA co-approval a hard gate; confirm the retention period against your schedule.