| Field | Value |
|---|---|
| Document ID | QC-IPC-002 |
| Document Title | In-Process Acceptance Criteria Specification |
| Version | v1.0 |
| Effective Date | 03/01/2026 |
| Owner | Quality Unit (QU) |
| Approval Authority | Quality Unit (QU) |
| Change Control | Required |
This specification establishes objective, enforceable in-process acceptance criteria governing batch progression during manufacturing execution. It defines measurable thresholds, invalid states, escalation triggers, and mandatory Quality Management System (QMS) workflow entries.
This specification mitigates risk of continued processing of nonconforming material, systemic process instability, suppression of out-of-specification results, and unauthorized continuation following control failure.
21 CFR Part 111 requires establishment of specifications, testing and examination to verify conformance, production and process controls, and Quality Unit oversight of quality decisions. Failure to enforce objective in-process decision rules creates regulatory exposure under 21 CFR 111.70, 111.75, 111.80, and 111.105.
Applies To: All in-process tests and parameter verifications documented in approved Master Manufacturing Records (MMR) and Batch Production Records (BPR).
Excludes: Finished product release testing and stability testing.
Compliant State: All acceptance criteria satisfied.
Nonconforming State: One or more acceptance criteria not met.
Invalid State: Record incomplete, instrument outside calibration, missing authorization, or required control undefined.
Escalation Trigger: Objective condition requiring mandatory QMS entry.
Stop-Execution Condition: Execution is prohibited until QMS resolution and QU authorization.
| Attribute | Compliant State | Nonconforming State | Invalid State | Escalation Trigger | Required QMS Process Entry | QU Authorization Required? |
|---|---|---|---|---|---|---|
| Measured Parameter | Result ≥ LSL AND ≤ USL | Result < LSL OR > USL | Result missing or altered | Any result < LSL OR > USL | Quality Event + MRB | Yes |
| Repeat OOS Threshold | ≤ 2 consecutive OOS events | > 2 consecutive OOS events | OOS trend data unavailable | > 2 consecutive OOS events | Quality Event | Yes |
| Instrument Calibration Status | Calibration expiration date ≥ execution date | Calibration expiration date < execution date | Calibration record unavailable | Calibration expiration date < execution date | Quality Event | Yes |
| Documentation Timestamp Integrity | Entry timestamp = execution date | Entry timestamp > 24 hours after execution | Timestamp missing or modified | Timestamp missing OR > 24 hours after execution | Quality Event | Yes |
Lower Specification Limit (LSL) and Upper Specification Limit (USL) are defined in the approved product specification and/or Master Manufacturing Record (MMR). This specification governs evaluation and decision logic only and does not define product-specific limits.
Systemic and trending evaluation of in-process results, including non-consecutive OOS events, is governed under the Quality Management System trending and CAPA programs and is not controlled within this specification.
| Attribute | Sampling Type | Frequency | Sample Size | Evaluation Method | Sampling Location | Sampling Method |
|---|---|---|---|---|---|---|
| [Defined in MMR / Product Specification] | Time-based (fixed interval) OR unit-based (defined quantity) | Defined in MMR (within QC-established requirements) | Defined in MMR (minimum sample size requirements apply) | Defined in MMR (e.g., average, individual units, composite sample) | Defined in MMR (sampling point must be representative of process output) | Representative sample appropriate to material form and process |
Sampling parameters defined in the MMR shall comply with Quality Unit-established requirements for sampling frequency, sample size, and evaluation methodology.
| Trigger Condition | Execution May Continue? | Required Action | QMS Process Entry | Workflow (W)? | QU Authorization (A)? | Required Record |
|---|---|---|---|---|---|---|
| Compliant State | Yes | Continue execution | None | No | No | Batch Production Record |
| Nonconforming State | No | Execution is prohibited when Nonconforming State occurs. | Quality Event | Yes | Yes | Quality Event Record |
| Invalid State | No | Execution is prohibited when Invalid State occurs. | Quality Event | Yes | Yes | Quality Event Record |
| Systemic / Repeated Failure (≥ 2 consecutive OOS) | No | Escalate systemic failure condition. | Quality Event | Yes | Yes | CAPA Record |
When any result < LSL OR > USL occurs, Quality Event entry is mandatory.
When ≥ 2 consecutive OOS events occur, Quality Event entry is mandatory.
When calibration expiration date < execution date, Quality Event entry is mandatory.
When in-process limits require modification, Change Control entry is mandatory.
E — Execution: Operations execute in-process controls and record results. Execution does not confer disposition authority.
W — Workflow Entry: QA administers required QMS workflow entries.
A — Authorization: QU authorization is required prior to batch continuation following any Nonconforming or Invalid State.
Compliant State: All acceptance criteria satisfied.
Nonconforming State: One or more acceptance criteria not met.
Invalid State: Record incomplete, instrument outside calibration, missing authorization, or required control undefined.
Escalation Trigger: Objective condition requiring mandatory QMS entry.
Stop-Execution Condition: Execution is prohibited until QMS resolution and QU authorization.
Change Control entry required. Independent Quality Unit approval required. No implementation without QU authorization.