Form: In-Process Pool Disposition Record

This is a ready-to-use disposition form for an in-process pool at a biologics purification step. Replace every <<FILL: ...>> placeholder with your own specifics. Retain per your records retention schedule. A worked filled specimen follows.

Instructions

Complete one form per pool, per step, per batch.
Tier every attribute as Acceptance (hard pass/fail), Action (internal review trigger, not a batch failure by itself), or Report-only (recorded, no pass/fail at this stage) exactly as defined in the approved control strategy.
A pool may not advance to the next step until this form is completed and, for any Acceptance-tier failure, an OOS investigation is opened.

Field	Entry
Product	`<<FILL>>`
Batch / lot number	`<<FILL>>`
Step	`<<FILL: e.g. Protein A capture pool>>`
Date/time collected	`<<FILL>>`
Pool volume	`<<FILL>>`

Disposition table

Attribute	Tier	Limit	Method	Result	Meets limit?
Step yield	Action	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Protein concentration	Acceptance	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
pH	Acceptance	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
HCP	Action / Report	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Aggregate (HMW)	Acceptance	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Leached ligand	Report	track	`<<FILL>>`	`<<FILL>>`	n/a
Bioburden	Acceptance	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Endotoxin	Acceptance	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
`<<FILL: additional attribute>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`

Disposition decision

Question	Answer
Any Acceptance-tier attribute out of limit?	Yes / No
If Yes, OOS reference opened	`<<FILL: number>>`
Any Action-tier attribute triggered?	Yes / No
If Yes, review/action taken	`<<FILL>>`
Pool disposition	Advance to next step / Hold pending investigation / Reject

Sign-off

Role	Name	Signature	Date
Tested by (QC)	`<<FILL>>`
Reviewed by (Manufacturing)	`<<FILL>>`
Approved by (QA, required for any non-standard disposition)	`<<FILL>>`

Filled specimen

Illustrative Protein A capture pool.

Attribute	Tier	Limit	Result	Meets limit?
Step yield	Action	greater than or equal to 90% (alert less than 92%)	95%	Yes
Protein concentration	Acceptance	8-15 g/L	11.2 g/L	Yes
pH	Acceptance	3.4-3.7	3.55	Yes
HCP	Action/Report	less than or equal to 500 ppm (alert)	410 ppm	Yes
Aggregate (HMW)	Acceptance	less than or equal to 2.0%	0.9%	Yes
Bioburden	Acceptance	less than or equal to 10 CFU/10 mL	less than 1	Yes
Endotoxin	Acceptance	less than or equal to 0.25 EU/mg	0.04 EU/mg	Yes

Disposition: all Acceptance-tier attributes within limit, no OOS opened; step yield and HCP within alert bands, no action triggered. Pool advanced to AEX polishing.

Common inspection findings this form prevents

A pool advanced past an out-of-specification result with no OOS investigation opened.
Action-tier and Acceptance-tier results treated interchangeably, so an alert excursion is wrongly escalated as a batch failure, or a real specification breach is wrongly downgraded to “action only.”
No documented tester, reviewer, and approver chain for the disposition decision.
A disposition made and the batch advanced before all Acceptance-tier results were available.

How to adapt this form

Populate the attribute table from your approved control strategy and pool specification for this specific step.
Confirm every limit traces to a source (release spec, Stage 1 study, or statistical process capability) as documented in the parent validation package.
Route any Acceptance-tier failure through your OOS investigation procedure before further disposition.
If built into an electronic batch record system, validate the tiering logic and the advance/hold/reject workflow.