Sampling Plan Governance Specification
This specification defines the Quality Unit–approved governance requirements for the establishment, approval, and control of sampling plans used in GMP operations.
Authoritative Quality Control specification defining sampling plan governance and decision authority. This document does not define sampling techniques, statistical calculations, or execution procedures.
1. Purpose
To establish Quality Unit–approved requirements governing how sampling plans are designed, approved, and maintained, ensuring that sampling performed in support of GMP decisions is appropriate, controlled, and fit for its intended purpose.
2. Scope
This specification applies to all sampling plans used to support acceptance, testing, release, or disposition decisions for components, materials, in-process materials, finished products, and packaging components.
Applicable Business Domains include:
- Quality Control (QC)
- Quality Assurance (QA)
- Warehouse Operations (WH)
- Production (PROD)
- Packaging (PKG)
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-SAMP-001
Sampling plan governance requirements defined in this specification shall not be modified outside approved QMS change control.
4. Sampling Plan Governance Requirements
| Governance Element | Requirement | Applicability |
|---|---|---|
| Plan Definition | Sampling plans shall be formally defined, documented, and approved prior to implementation. | All GMP-relevant sampling activities |
| Plan Approval | Sampling plans shall be reviewed and approved by the Quality Unit. | All sampling plans |
| Purpose Alignment | Sampling plans shall be appropriate for the intended decision (e.g., identity verification, purity assessment, acceptance). | All sampling plans |
| Risk Consideration | Sampling plans shall consider material criticality, supplier performance, historical data, and risk to product quality. | Sampling plans supporting GMP decisions |
| Plan Change Control | Changes to approved sampling plans shall be controlled and approved through the Quality Management System. | All sampling plan revisions |
Sampling plans may reference recognized statistical or scientific approaches; however, the selection and adequacy of the plan are subject to Quality Unit approval.
5. Decision Logic
- Sampling plans approved and implemented in accordance with this specification are considered conforming.
- Sampling conducted outside an approved sampling plan requires Quality Assurance review.
- Inadequate, inappropriate, or undocumented sampling plans shall not be used to support GMP acceptance or release decisions.
- Final determinations regarding sampling plan adequacy reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Sampling plans are missing, outdated, or not approved
- Sampling plans are misaligned with the intended quality decision
- Unapproved deviations from sampling plans occur
- Recurring sampling-related deficiencies or trends are identified
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Approved sampling plans and revisions
- Sampling execution records referencing approved plans
- Deviation and investigation records related to sampling
- Quality Unit approvals and governance documentation