Sampling Representativeness Specification
This specification defines the Quality Unit–approved requirements ensuring that samples collected for GMP decisions are representative of the lot, batch, or population from which they are taken.
Authoritative Quality Control specification defining sampling representativeness requirements and decision authority. This document does not define statistical calculations, sample sizes, or sampling execution techniques.
1. Purpose
To establish Quality Unit–approved requirements ensuring that sampling activities yield samples that adequately represent the material, lot, batch, or population being evaluated, thereby supporting valid quality decisions.
2. Scope
This specification applies to all sampling performed in support of GMP acceptance, testing, release, or disposition decisions for components, raw 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-003
Sampling representativeness requirements defined in this specification shall not be modified outside approved QMS change control.
4. Sampling Representativeness Requirements
| Representativeness Principle | Requirement | Applicability |
|---|---|---|
| Lot Coverage | Samples shall be selected to reflect the full lot, batch, or population and not be limited to a single location, container, or timepoint unless justified. | All GMP-relevant sampling |
| Process Variability | Sampling shall consider known or potential sources of variability within the process, material, or lot. | Sampling supporting acceptance or release decisions |
| Material Characteristics | Sampling approaches shall account for physical form, homogeneity, segregation potential, and handling characteristics of the material. | Components, in-process materials, and finished products |
| Bias Avoidance | Sampling shall be performed in a manner that avoids intentional or unintentional bias toward favorable results. | All sampling activities |
| Justification of Limitations | Where full representativeness cannot be achieved, limitations shall be scientifically justified and approved by the Quality Unit. | Sampling plans with constraints or exceptions |
Sampling representativeness is evaluated based on documented rationale and alignment with approved sampling plans and intended quality decisions.
5. Decision Logic
- Sampling approaches meeting representativeness requirements are considered conforming.
- Sampling that does not adequately represent the lot shall not be used to support GMP acceptance or release decisions.
- Identified representativeness concerns require Quality Unit review prior to decision-making.
- Final determinations regarding sampling representativeness reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Sampling methods fail to adequately represent the lot or batch
- Sampling bias or selection concerns are identified
- Limitations or constraints impacting representativeness are identified
- Recurring sampling representativeness deficiencies or trends
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Approved sampling plans and representativeness justifications
- Sampling records demonstrating lot coverage
- Deviation and investigation records related to sampling bias or limitations
- Quality Unit reviews and approvals regarding sampling adequacy