GMP Compliance

Practical GMP support for quality systems, operational governance, deviations, CAPA, change control and inspection readiness.

Independent RP support for WDA(H) quality-system governance, self-inspection, suppliers, recalls and ongoing GDP oversight.

Responsible Person (RP)

GDP & WDA(H) Support

GDP and WDA(H) support covering authorised activities, suppliers, customers, storage, transport and outsourced operations.

GMP & GDP Auditing

Independent, risk-based GMP and GDP audits for internal systems, suppliers, service providers and inspection preparation.

Responsible Person (import) — RPi

RPi verification-system support for eligible imports into Great Britain, including QP certification and batch-release evidence controls.

Inspection Readiness

Mock inspection, evidence-room governance, response drafting, root-cause analysis, CAPA and sustained remediation support.

GMP, GDP, RP, RPi & Auditing Services

PQS design and improvement, document control, risk management, data integrity, training effectiveness and management review.

Quality Systems

Hands-on support for regulated operations, responsible roles, documentation, quality governance and practical problem solving.

Operational Compliance

Specialist Cleanroom Support

Cleanroom design, validation, contamination control strategy and Annex 1 support through W2 Cleanroom Consulting.

GMP Compliance & Operational Governance

GMP/GDP Auditing & Inspection Readiness

Aseptic & Healthcare Production Support

Quality Management

Our Quality Management support spans the full lifecycle of a robust QMS, from initial setup through to audit-ready maturity. We assist in designing and reviewing:

• Quality Manuals with clear scope, authority, and document control strategy

• Hierarchy maps that define the relationship between SOPs, policies, and work instructions

• Deviation and change control workflows tailored to your team's structure and communication flow

• Governance structures that embed quality at every level, including QRM, self-inspection, and CAPA oversight

• Capacity planning models to ensure staffing, batch volumes, and documentation flow align with MHRA expectations

• KPI frameworks that drive continuous improvement through meaningful quality metrics

  All documentation is designed for daily operational use, not just compliance and informed by our direct experience in licensed manufacturing roles. Whether you're refreshing a legacy QMS or building from scratch, we provide practical, inspection-tested tools to keep your operation audit-ready and scalable.

Cleanroom Commissioning

We support teams through the complex process of bringing cleanrooms into GMP operation, including:

• DQ, IQ, and OQ planning support

• Environmental monitoring (EM) strategy and zoning reviews

• Qualification and first fill planning aligned to Annex 1

• Gowning assessments and visual inspection readiness

• Review of commissioning reports and cleanroom supplier handover

Whether it’s a new build or refurbishment, we help translate specs into operational reality.

Workforce & Operations

We offer hands-on support in shaping the workforce and daily running of aseptic services, including:

• Defining roles, banding, and escalation structures

• Rota design for 7-day services or extended shifts

• Coverage models and annual leave planning for critical roles

• Building positive culture through structured meetings and communication

• Operational readiness assessments before go-live

We’ve helped build departments from scratch and can help yours run smoothly from day one.

Document Support

We help organisations improve their document landscape, ensuring alignment with MHRA and GMP expectations, including:

• Authoring clear, audit-ready SOPs, work instructions, and log templates

• Reviewing and reformatting legacy documents for clarity and traceability

• Structuring document hierarchies across Quality Manuals, policies, and procedures

• Supporting controlled document lifecycle management (versioning, approval, and archive)

• Embedding good documentation practices from Day One

Let’s Build Something That Works

From full aseptic start-ups to streamlining routine prep, WinnPharma supports organisations that want more than templates. We bring practical, proven systems that match MHRA expectations and real-world pressure.

Got a project in mind? Let's talk.

Audit Preparation

We support teams preparing for regulatory inspections by offering realistic and structured audit readiness services, including:

• Mock inspections aligned with MHRA and internal standards

• Document walkthroughs to identify gaps or outdated procedures

• Staff coaching and practice Q&A for common audit lines of inquiry

• Environment and documentation flow assessments from a GMP lens

• Action plans to address findings with realistic timelines

Whether you’re inspection-ready or just starting out, we’ll help you strengthen confidence and control.

Training Packages

We create tailored training solutions that build capability and confidence across all levels of your team, including:

• Designing role-based induction and annual refresher programmes

• Creating visual and written content for SOP-based learning

• Developing competency assessments and tracking tools

• Building training matrices aligned with regulatory requirements

• Supporting audit trails and records for inspection

Your team deserves training that actually prepares them for the job