Critical Process Parameter Governance Specification

This specification defines the Quality Unit–approved requirements governing the identification, classification, control, and oversight of critical process parameters that impact product quality in GMP operations.

Specification Type:
Authoritative Quality Control specification defining critical process parameter governance and decision authority. This document does not define manufacturing instructions, equipment operation, or procedural execution.

1. Purpose

To establish Quality Unit–approved governance requirements for determining which process parameters are critical to product quality and how those parameters are controlled, monitored, and evaluated during GMP operations.

2. Scope

This specification applies to all GMP manufacturing, processing, and packaging operations where process parameters may impact product identity, strength, purity, quality, or safety.

Applicable Business Domains include:

Production (PROD)
Packaging (PKG)
Quality Control (QC)
Quality Assurance (QA)
Engineering & Facilities

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-001

Critical process parameter governance requirements defined in this specification shall not be modified outside approved QMS change control.

4. Critical Process Parameter Governance Requirements

Governance Element	Requirement	Applicability
CPP Identification	Process parameters that may directly impact product quality shall be identified and classified based on risk and scientific rationale.	All GMP processes
CPP Classification	Critical process parameters shall be clearly distinguished from non-critical or informational parameters.	All identified process parameters
Control Strategy Alignment	CPPs shall be governed by defined control strategies appropriate to their risk and impact.	All critical process parameters
Monitoring & Evaluation	CPPs shall be monitored or evaluated at a frequency sufficient to detect loss of control or adverse trends.	All critical process parameters
Change Impact Assessment	Changes impacting CPPs shall be evaluated for potential effect on product quality prior to implementation.	Changes involving CPPs

Identification and classification of CPPs shall be based on product knowledge, process understanding, risk assessment, and historical data, as appropriate.

5. Decision Logic

Process parameters identified and governed as CPPs are subject to enhanced control and oversight.
Loss of control of a CPP requires evaluation and potential escalation.
CPP governance shall be periodically reviewed to ensure continued appropriateness.
Final determinations regarding CPP identification and control reside with the Quality Unit.

6. Escalation Requirements

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

Loss of control or excursion of a critical process parameter
Unapproved changes impacting CPPs
Recurring CPP-related deviations or trends
Disagreement regarding CPP classification or control strategy

7. Records & Evidence

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

CPP identification and classification documentation
Risk assessments and scientific justifications
Process monitoring and evaluation records
Quality Unit decisions related to CPP governance

This specification defines critical process parameter governance and decision authority only. Manufacturing procedures, equipment operation, and execution details are defined in separate controlled documents and shall not redefine the requirements herein.