Wardcroft

What Wardcroft does

More than 20 years of hands-on quality leadership across pharmaceutical, complementary medicine, biotechnology, food and beverage, and FMCG manufacturing. Work ranges from a single audit-readiness review, to building a quality system, to covering a quality manager role.

Quality systems and GMP

  • Quality management system design, build and uplift
  • GMP gap assessments (TGA and PIC/S)
  • Audit and TGA inspection readiness, including mock audits
  • Responding to audit findings with corrective action plans
  • SOPs, quality manuals and document control systems
  • Internal audit programs and independent audits
  • Training programs and competency records, and GMP, data integrity and internal auditor training courses
  • TGA manufacturing licence applications and variations

Investigations and risk

  • Deviations, root cause investigation and CAPA
  • Change control
  • Quality risk management
  • Complaints, recalls and mock recalls
  • Batch record review and release procedures

Suppliers

  • Supplier qualification and approved supplier programs
  • Supplier audits on behalf of manufacturers
  • Supplier quality agreements

Validation and data integrity

  • Computer system validation (GAMP 5, 21 CFR Part 11, EU GMP Annex 11)
  • Data integrity (ALCOA+)
  • Process, cleaning and equipment validation and qualification
  • Clean room validation, qualification and requalification

QC laboratory

  • QC laboratory setup and management
  • Out-of-specification and out-of-trend investigations
  • Stability programs and method validation
  • Laboratory data systems, reports and dashboards

Warehouse

  • Warehouse and storage compliance for GMP materials and products
  • Goods receipt, quarantine, material status and stock control
  • Warehouse procedures, records and training

Production

  • Production procedures and batch record review and improvement
  • Line clearance, in-process controls and sign-offs
  • Supporting production teams to meet GMP expectations

Specifications, formulations and label claims

  • Raw material and finished product specifications
  • Formulation review and development support
  • Label claims review
  • Helping new products and projects work out the best way to proceed, from the start

Food, beverage and FMCG

  • HACCP plan support and reviews
  • FSANZ Food Standards Code compliance support

Process improvement

  • Process mapping and improvement: finding where time, errors and rework hide
  • Continuous improvement and lean thinking
  • Simplifying paperwork, approvals and handovers
  • Dashboards and reports from your existing data

Safety and environment

  • EH&S systems and audits

Interim and team support

  • Interim or contract quality manager, and QA and QC cover
  • Building and coaching quality teams

Software

  • Kantan eQMS, our own electronic quality management system. Learn about Kantan
  • eQMS and LIMS selection and implementation support. Because Wardcroft also develops Kantan, we will ensure you get the best fit.

Not sure what you need? Tell us what you are dealing with. Email info@wardcroft.com