Aseptic Preparation

Providing expert advice and guidance on aseptic preparation processes to ensure safety and compliance.

Optimising aseptic processes for safety, efficiency, and regulatory compliance

Manufacturing
a person in a lab coat looking at a mirror
a person in a lab coat looking at a mirror
person writing on white paper
person writing on white paper
Facility Design

Supporting layouts, workflows, and start-up plans for new aseptic units

black and gray laptop computer
black and gray laptop computer
Quality Management

Building QMS frameworks aligned with MHRA and EU GMP requirements

Audit Preparation

Helping teams get inspection-ready with mock audits and compliance walkthroughs.

person writing bucket list on book
person writing bucket list on book
Document Support

Authoring and reviewing SOPs, forms, work instructions, and GMP templates.

person in white pants and white shirt holding clear glass tube
person in white pants and white shirt holding clear glass tube

Our Services

five human hands on brown surface
five human hands on brown surface
person using laptop
person using laptop

Creating engaging training content and role-specific competency frameworks.

Training Packages

Helping you structure rotas, roles, and operational culture in aseptic services.

Workforce & Operations
Cleanroom Commissioning

Supporting environmental validation and qualification.

Manufacturing

We support aseptic manufacturing teams to optimise process flows, reduce waste, and meet regulatory expectations, without compromising safety. Our input includes:

  • Batch workflow design, including staging, reconciliation, and in-process checks

  • Line clearance walkthroughs and documentation alignment

  • Support with first fills, setup/hold time reviews, and cleanroom handovers

  • Practical troubleshooting for workflow gaps or delays

We draw on real operational experience to make your processes faster, safer, and easier to audit.

Facility Design

We prepare teams for MHRA inspections and internal audits with a calm, structured approach. Our support includes:

  • Full mock audits tailored to your site’s scope and risk areas

  • Live feedback during walkthroughs, plus a written report with RAG findings

  • Coaching staff on how to respond to inspectors confidently and clearly

  • CAPA suggestions based on real-world MHRA experience

We don’t just help you fix gaps, we help your team understand what good looks like.

Aseptic Preparation

We provide practical support to ensure your aseptic preparation processes are safe, compliant, and efficient. Our input includes:

  • Advice on setup, equipment checks, and critical step sequencing

  • Hold time risk assessments and validation strategy

  • Workflow improvements for media fills and cleanroom entries

  • Operator support on best practice aseptic technique

Whether you're running daily chemotherapy production or complex clinical trials, we help ensure every step stands up to MHRA scrutiny.

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.

Contact Us

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