Quality Systems Administration — Context International

Service 03 / GxP Quality

Quality Systems Administration

Quality systems exist on paper everywhere. Functioning quality systems — ones that survive inspection, prevent deviations from recurring, and support a culture of compliance — require dedicated administrative capacity that most lean pharmaceutical operations cannot sustain internally.

"A quality system is only as strong as the rigour with which it is maintained between inspections — not the days before one."

Context International — Quality Operations Principle

GxP Coverage

The quality disciplines we administer

GMP

Good Manufacturing Practice

Quality systems administration for manufacturing sites and their partners. SOP management, batch record review, deviation handling, and compliance programme maintenance.

SOP lifecycle management
Batch record QC review
Deviation and OOS administration
Supplier qualification tracking

GCP

Good Clinical Practice

Clinical trial quality systems — from protocol documentation through TMF maintenance and audit trail management. ICH E6(R2) and R3 compliant administration throughout the trial lifecycle.

Protocol and amendment management
TMF structure and maintenance
Site qualification documentation
Audit preparation support

GVP

Good Vigilance Practice

Pharmacovigilance quality system maintenance — PSMF updates, process documentation, audit trail management, and GVP module compliance tracking across your PV operation.

PSMF maintenance and versioning
PV process documentation
GVP gap assessments
Audit response management

CAPA Management

Corrective and preventive action — end to end

The lifecycle of a quality event doesn't end at identification. We manage it through to verified closure — with the documentation rigour an inspector expects to see.

Detection

Event identified via audit, monitoring, complaint, or internal observation

Assessment

Impact, risk, and scope evaluated against product quality and patient safety

Root Cause

Systematic RCA conducted — 5 Whys, Fishbone, or fault tree analysis

Implementation

Corrective and preventive actions designed and executed with owner accountability

Verification

Effectiveness check confirms root cause addressed and recurrence prevented

Closure

Documented closure with trend data and lessons learned distributed

Documentation System

Quality documentation — structured and controlled

Policy Level

Quality Manual

Top-level policy document. Defines quality commitments and GxP philosophy.

Quality Policy

Organisational commitment to quality and regulatory compliance.

PSMF

Pharmacovigilance System Master File — annual maintenance obligation.

Regulatory Strategy

Documented position on regulatory submissions and authority interactions.

Process Level

SOPs

Standard operating procedures for every quality-critical process.

Work Instructions

Step-level operational guides for complex processes.

Process Maps

Visual workflows supporting SOP comprehension and training.

Validation Protocols

System and process validation documentation for GxP environments.

III

Record Level

Batch Records

Manufacturing and packaging documentation reviewed for compliance.

Audit Reports

Internal and external audit findings tracked to verified closure.

Training Records

Personnel qualification and SOP training completion documentation.

CAPA Records

Corrective and preventive action management from detection through closure.

Inspection mindset

Inspectors do not announce which day they will look most carefully at your documentation. We assume every day is that day.

Inspection Readiness

We prepare for inspections — not during them

EMA / National Authority

GVP Inspection Readiness

EMA pharmacovigilance inspections assess the entire PV system — not just case processing. We ensure the infrastructure, documentation, and processes inspectors examine are in order before any notification arrives.

PSMF current, accurate, and auditable
SOP inventory complete with version control
Training records matched to role requirements
CAPA programme with verified closures on file
Case processing metrics and KPI documentation
Signal management records with full audit trail

GCC Regulatory Authorities

GCC Site Inspection Support

GCC regulatory authorities are expanding local inspection capacity. MOHAP and SFDA site inspections increasingly cover PV systems, quality infrastructure, and documentation standards of UAE and KSA-registered companies.

Local authority contact and correspondence files
GCC-specific PV procedures documented
Local qualified person designation records
Market surveillance and complaint handling documentation
Expiry and recall management procedures in place
Mock inspection conducted with findings closed

Ready to build a quality system that functions between inspections?

GxP compliance is not an event — it's an operation. We provide the administrative capacity to keep your quality system current, controlled, and audit-ready at all times.

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