Component Purity & Contaminant Acceptance Specification
This specification defines the Quality Unit–approved purity and contaminant acceptance criteria and decision requirements for components and raw materials prior to use in GMP operations.
Authoritative Quality Control specification defining purity and contaminant acceptance criteria and decision authority. This document does not define test methods, sampling plans, or laboratory execution procedures.
1. Purpose
To establish Quality Unit–approved requirements for evaluating component purity and contaminant levels, ensuring that materials used in GMP operations meet defined quality expectations and do not present a risk to product quality, safety, or regulatory compliance.
2. Scope
This specification applies to all components and raw materials used in GMP manufacturing, packaging, and testing activities, including active ingredients, excipients, processing aids, and packaging components where purity or contamination may impact product quality.
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-MAT-002
Purity and contaminant acceptance requirements defined in this specification shall not be modified outside approved QMS change control.
4. Purity & Contaminant Acceptance Requirements
| Attribute | Acceptance Requirement | Applicability |
|---|---|---|
| Component Purity | Conformance to approved component specification purity criteria | All components and raw materials where purity is defined |
| Chemical Contaminants | Levels shall not exceed approved specification or regulatory limits | As applicable based on component type and intended use |
| Microbiological Contamination | Levels shall not exceed approved specification limits and shall not present a risk to product quality | Components where microbial quality is relevant |
| Foreign Matter | Materials shall be free from extraneous or foreign matter that may impact suitability for use | All components and packaging materials |
Numeric limits, test parameters, and specific acceptance values are defined in approved component specifications, product specifications, or applicable regulatory standards. Where multiple limits apply, the most restrictive requirement shall govern.
5. Decision Logic
- Components meeting approved purity and contaminant acceptance criteria are considered conforming.
- Components failing to meet purity or contaminant criteria shall not be released for GMP use.
- Atypical, borderline, or unexpected results require escalation to Quality Control for assessment.
- Final determinations regarding component purity acceptance or rejection reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Failure to meet approved purity or contaminant acceptance criteria
- Detection of unexpected or prohibited contaminants
- Recurring purity failures or adverse trends
- Discrepancies between supplier documentation and test results
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- Component test results and certificates of analysis
- Purity and contaminant assessment records
- Deviation, investigation, and corrective action documentation
- Quality Unit decisions regarding material acceptance or rejection