PHARMACEUTICAL GMP • QUALITY • VALIDATION

GMP compliance that holds up in real execution.

AVISAN helps pharmaceutical manufacturers and distribution companies turn requirements into controlled, evidence-based, inspection-defensible execution.

Start a scope discussion↗Services overview↓

WHO GMPEU GMPPIC/SICH Q9 & Q10

AVISAN CONTROL MODEL

Design

Execution

Verification

PROVEN BYEvidence

Services overview

Specialist support across the GMP lifecycle

From quality-system design and technical documentation to qualification, shopfloor execution and inspection readiness.

GMP Review & Gap Assessment

System-level reviews that connect written requirements with execution, ownership and available evidence.

VIEW SERVICE02

Inspection Readiness

Risk-based readiness plans, evidence-room preparation, walkthroughs and challenge-response support.

VIEW SERVICE03

Pharmaceutical Quality Systems

QMS design and improvement across deviation, CAPA, change control, PQR, training and management review.

VIEW SERVICE04

Quality Risk Management & Audits

ICH Q9-aligned risk governance, specialized audits, supplier oversight and defensible decisions.

VIEW SERVICE05

Validation & Qualification

VMP, DQ, IQ, OQ and PQ strategies for equipment, facilities, utilities, processes and cleaning.

VIEW SERVICE06

Engineering Quality & Critical Utilities

Quality oversight for HVAC, cleanrooms, PW/WFI, compressed gases, mapping and lifecycle control.

VIEW SERVICE07

Sterile, Non-Sterile & Potent Operations

Support for aseptic, terminally sterilized, OSD, softgel, potent and biotech operations.

VIEW SERVICE08

GDP, Storage & Distribution

GDP/GSP systems, temperature mapping, transport qualification, warehousing and vendor control.

VIEW SERVICE09

Technical & Regulatory Documentation

SOPs, SMF, URS, protocols, reports, layouts, CTD support and role-based GMP training.

VIEW SERVICE

Industries & operations

Experience shaped around operational risk

AVISAN support is structured around the product, process and facility risks that define each operating environment.

Sterile & Parenteral

Aseptic processing, terminal sterilization, media fill, contamination control and sterile utilities.

Oral Solid Dosage

Tablets, capsules, coating, granulation, cleaning and general or potent manufacturing.

Softgel & Potent

Containment, cross-contamination control, cleaning validation and engineering controls.

Biotech Manufacturing

Upstream and downstream operations, classified flows, utilities and process support systems.

Distribution & Warehousing

GDP, storage, cold chain, temperature mapping, transport and vendor governance.

How we work

Control must be demonstrated — not assumed.

We connect documents, decisions and shopfloor evidence so the system can defend itself under inspection.

Documents describe the system. Evidence proves it is in control.

01Define scope & critical risks
02Review evidence & system design
03Test execution reality
04Build a risk-based roadmap
05Support closure & readiness

Selected experience

Selected project experience

Representative scopes from real pharmaceutical work. Client and site identities remain confidential.

CLIENT CONFIDENTIAL

Jul 2024–PresentSterile injectable company

GMP Training & Quality System Implementation

Customized GMP training for production, QC and QA, together with integrated QMS implementation across SOPs, deviation, CAPA and internal audit, plus ongoing compliance and inspection-readiness support.

CLIENT CONFIDENTIAL

Dec 2022–Apr 2024Sterile manufacturing site

End-to-End GMP Compliance & Validation Program

Comprehensive support covering PW/WFI qualification, HVAC, process and cleaning validation, GMP documentation, personnel training and operational readiness through GMP approval.

CLIENT CONFIDENTIAL

Mar–May 2023Sterile manufacturing facility

Purified Water & WFI System Qualification

Design review, FAT/SAT supervision, PQ protocol preparation and execution, sampling and monitoring strategy, and risk-based validation documentation.

CLIENT CONFIDENTIAL

Current engagementParenteral project

End-to-End GMP Execution Support

Quality-system architecture, core GMP documentation, layout and flow review, qualification alignment, practical execution support and personnel readiness.

CLIENT CONFIDENTIAL

Selected projectPharmaceutical storage

Temperature Mapping & Control Evidence

Mapping strategy, protocol and sensor-location review, execution support, data assessment, deviation handling and final-report structure.

CLIENT CONFIDENTIAL

Selected projectPharmaceutical facility

Documentation, Layouts & Workforce Readiness

GMP documentation development, layout and personnel/material-flow review, role-based training and implementation support.

Insights

AVISAN GMP Review Notes

Short, experience-led observations on the gaps between paper compliance and controlled execution.

FLOW & EXECUTION

An approved flow map does not prove shopfloor control

Design is defensible only when actual personnel and material movement are verified against it.

READ NOTE ↗

IMPACT ASSESSMENT

Reanalysis planned does not defend the impact period

The risk window must start from the earliest plausible failure — not the next scheduled test.

READ NOTE ↗

QUALIFICATION

Qualified does not always mean process-ready

A passed protocol is not enough when operating ranges, alarms and routine decisions remain unverified.

READ NOTE ↗

About AVISAN

A specialist GMP consulting and execution group

AVISAN brings together pharmaceutical quality, validation, engineering and regulatory thinking to help organizations build systems that work in routine operation — not only on paper. Engagements can be delivered remotely, on-site or through a hybrid model across the Middle East.

Practical

Recommendations are designed for implementation.

Risk-based

Effort follows product, patient and compliance risk.

Evidence-driven

Control is demonstrated through traceable evidence.

Inspection-defensible

Decisions and execution must withstand challenge.