In-Process Acceptance Criteria Specification

This specification defines the Quality Unit–approved acceptance criteria and decision requirements governing in-process tests, checks, and evaluations used to support continued processing during GMP operations.

Specification Type:
Authoritative Quality Control specification defining in-process acceptance criteria and decision authority. This document does not define manufacturing procedures, sampling techniques, or execution workflows.

1. Purpose

To establish Quality Unit–approved requirements governing how in-process results are evaluated against acceptance criteria to determine whether manufacturing or packaging operations may continue, pause, or require escalation.

2. Scope

This specification applies to all in-process tests, checks, measurements, and evaluations performed during GMP manufacturing and packaging operations that are used to support continued processing decisions.

Applicable Business Domains include:

Production (PROD)
Packaging (PKG)
Quality Control (QC)
Quality Assurance (QA)

3. Ownership & Governance

Owner: Quality Control (Quality Unit)
Approver: Quality Control Operations (QCO)
Change Control: Quality Management System (QMS)
Requirement Authority: QC-REQ-IDX
QC-REQ-IDX Reference: QC-IPC-002

In-process acceptance criteria defined in this specification shall not be modified outside approved QMS change control.

4. In-Process Acceptance Criteria Requirements

Acceptance Element Requirement Applicability

Defined Criteria In-process acceptance criteria shall be clearly defined, documented, and approved prior to execution. All in-process tests and checks

Alignment with CPPs In-process acceptance criteria shall align with identified critical process parameters and control strategies. CPP-related in-process controls

Decision Support In-process results shall be used only to support defined decisions such as continue, pause, adjust, or escalate. All in-process evaluations

Limits & Tolerances Acceptance limits and tolerances shall be appropriate to process risk and product impact. All in-process criteria

Change Control Changes to in-process acceptance criteria shall be evaluated and approved prior to implementation. Revisions to acceptance criteria

In-process acceptance criteria may be qualitative or quantitative but shall be sufficient to support meaningful and timely quality decisions during execution.

Acceptance Element	Requirement	Applicability
Defined Criteria	In-process acceptance criteria shall be clearly defined, documented, and approved prior to execution.	All in-process tests and checks
Alignment with CPPs	In-process acceptance criteria shall align with identified critical process parameters and control strategies.	CPP-related in-process controls
Decision Support	In-process results shall be used only to support defined decisions such as continue, pause, adjust, or escalate.	All in-process evaluations
Limits & Tolerances	Acceptance limits and tolerances shall be appropriate to process risk and product impact.	All in-process criteria
Change Control	Changes to in-process acceptance criteria shall be evaluated and approved prior to implementation.	Revisions to acceptance criteria

5. Decision Logic

In-process results meeting acceptance criteria support continued processing.
Results outside acceptance criteria require pause, adjustment, or escalation based on defined decision rules.
In-process results shall not be ignored, averaged away, or deferred without Quality Unit oversight.
Final determinations regarding use of in-process results reside with the Quality Unit.

6. Escalation Requirements

Quality Assurance must escalate to Quality Control or QCO when any of the following occur:

In-process results exceed defined acceptance criteria
Loss of control of CPP-related in-process parameters
Repeated or trending in-process deviations
Unclear or conflicting in-process decision outcomes

7. Records & Evidence

Records supporting compliance with this specification include, but are not limited to:

Approved in-process acceptance criteria
In-process test and monitoring records
Deviation and investigation records related to in-process results
Quality Unit decisions regarding in-process control

This specification defines in-process acceptance criteria and decision authority only. Manufacturing instructions, sampling execution, and operational workflows are defined in separate controlled documents and shall not redefine the requirements herein.