OXY203 – Occupational Hygiene Risk Assessment & Control in Pharmaceutical Environments
Two-Day BOHS Endorsed Professional Programme (In-House Delivery Only)
This advanced programme provides structured guidance on undertaking defensible occupational hygiene risk assessments within pharmaceutical research, development and manufacturing environments.
Pharmaceutical settings demand more than generic COSHH compliance. Risk assessments must align with GMP/GxP principles, hazard banding frameworks, containment expectations and documented justification of control measures.
OXY203 equips delegates with the knowledge and practical methodology required to assess hazardous substances rigorously and implement proportionate, compliant control strategies.
Who This Programme Is Designed For
- Pharmaceutical QA and Compliance Managers
- EHS Managers within R&D and manufacturing environments
- Process Engineers and Technical Managers
- Validation and Facilities Professionals
- Occupational Hygiene Advisors supporting pharma sites
- Duty Holders responsible for hazardous substance management
Why This Programme Matters
In pharmaceutical environments, risk assessment under COSHH Reg 6 must integrate with GMP documentation, change control systems, hazard categorisation frameworks and containment design decisions.
This programme enables delegates to:
- Interpret legislative requirements within regulated pharma contexts
- Classify hazardous substances using structured categorisation approaches
- Develop proportionate and documented risk assessment methodologies
- Apply the Hierarchy of Control in high-containment environments
- Justify engineering controls including LEV and MBSC systems
- Understand the appropriate role and limitations of PPE
- Benchmark risk levels and document defensible control decisions
- Strengthen preparedness for audit and inspection
Programme Structure
Regulatory & Governance Framework
- Health & Safety at Work Act
- COSHH Regulations (including Reg 6 & Reg 9 interfaces)
- Hierarchy of Control in regulated environments
- Integration with GMP/GxP expectations
- Industry guidance and sector standards
Hazard Identification & Categorisation
- Interpreting Safety Data Sheets (SDS)
- Hazard banding and Occupational Health Categorisation (OHC)
- Understanding toxicological and exposure information
- Biological and chemical hazard considerations
Risk Assessment Methodology
- Structured preparation of COSHH risk assessments
- Risk level determination and benchmarking
- Documentation standards and audit defensibility
- Change control considerations in evolving processes
Control Strategies in Pharma Environments
- Dilution ventilation vs engineering containment
- LEV systems and containment enclosures
- Microbiological Safety Cabinets (MBSCs)
- Administrative controls and SOP integration
- Chemical Protective Clothing and eye/face protection
- Limitations of PPE as a primary control measure
Practical Scenario-Based Exercises
- Realistic pharmaceutical case studies
- Group-based assessment exercises
- Control strategy selection and justification
- Peer discussion and structured feedback
Delivery Format
Two-day programme delivered in-house only:
- Face-to-face at client premises
- Live interactive virtual delivery (site-specific cohort)
This course is designed for organisational teams to ensure consistent methodology and shared understanding across departments.
Certification
- BOHS Endorsed Digital Certificate
- 14 Hours Verified CPD Contact Time
Pre-Requisites
No formal qualifications required. Suitable for professionals involved in managing hazardous substances within regulated pharmaceutical environments.
Fees
In-House Delivery – Pricing Available on Application
BOHS Endorsed Certificate Fee: £60 + VAT per delegate
Professional Standards with OXYL8
This programme is delivered by specialists experienced in occupational hygiene, containment systems and regulatory interpretation within pharmaceutical environments.
The focus is on practical methodology, defensible documentation and strengthening organisational competence in hazardous substance risk management.
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