Service 07 / 18 · GMP & Compliance
Compliance Is Designed. Not Added Later.
GMP review runs alongside design, not after it. Layouts, flows, finishes and systems are checked against applicable international GMP guidelines and the requirements of the target markets. Gaps are recorded, assigned and closed, so compliance questions are resolved on the drawings rather than during inspection.
Engineering phases
Where this service fits
06 / 09 phases in scope
- 01Feasibilitynot in scope
- 02ConceptIn scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05Procurementnot in scope
- 06ConstructionIn scope
- 07Commissioningnot in scope
- 08ValidationIn scope
- 09OperationIn scope
Scope
What the service covers
- 01GMP design reviews at each design stage
- 02Gap assessments of existing facilities
- 03Regulatory requirements mapping for target markets
- 04Contamination control strategy input
- 05Inspection readiness support
Method
From inputs to deliverables
INInputs
04 items- I01Current design stage drawings or existing-facility records
- I02Product types and target markets
- I03Process description and equipment list
- I04Previous inspection or audit observations, where available
WORKActivities
05 items- W01Requirements mapping for target markets
- W02Structured design review workshops
- W03Site walk-downs of existing facilities
- W04Gap recording, rating and ownership
- W05Remediation planning and follow-up
OUTDeliverables
04 items- D-07.01GMP design review reports
- D-07.02Gap assessment and remediation plan
- D-07.03Regulatory requirements matrix
- D-07.04Compliance action tracker
Technical detail
GMP across the design
Contents · 04
01 / 04
How GMP shapes the design
- Zoning
- Personnel, material and waste flow
- Cross-contamination risk
- Pressure relationships
- Cleanroom strategy
- Utilities
- Equipment
- Cleaning
- Documentation
- Commissioning
- Qualification
02 / 04
GMP design reviews
- Reviews at concept, basic and detailed stages
- Checklist-based review against applicable guidelines
- Findings recorded with owner and due stage
- Closure verified on the next drawing issue
03 / 04
GMP gap assessment
- Comparison of current state with target requirements
- Risk-based rating of each gap
- Practical remediation options
- Prioritized remediation plan
04 / 04
Existing facility compliance review
- Walk-down of layouts, flows and finishes
- Review of HVAC and utility arrangements
- Identification of changes that need requalification
- Input to upgrade scope and phasing
Deliverables
Typical documents and outputs
- D-07.01GMP design review reports
- D-07.02Gap assessment and remediation plan
- D-07.03Regulatory requirements matrix
- D-07.04Compliance action tracker
Services
Related services
- 08
Qualification & Validation (CQV)
Documented evidence that facilities, utilities and equipment perform as intended.
- 18
Facility Upgrades & Retrofit
Expansions, upgrades and retrofits engineered around the facility that is already running.
From the first layout. Zoning, personnel and material flows, pressure relationships and utilities are hard to change once the design is fixed, so compliance considerations should shape the concept rather than be checked after it.
Yes. Upgrade studies, compliance gap reviews, engineering changes, utility improvements and expansion planning can be scoped around ongoing production, with phasing that limits disruption.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700