Bio Cleaning GMP

MORE THAN GMP COMPLIANCE

Bio Cleaning Consulting is a privately owned, global consulting and training company with over three decades of first-hand and senior management experience in Good Manufacturing Practices (GMP) within the Pharmaceutical and Biotechnology industries.

COMPLIANCE WITH CONFIDENCE

Want to find out about the Bio Cleaning Consulting advantage

Bio Cleaning Consulting is here and available to help you sort out your Contamination Control Strategy (CCS), Cleaning Validation (CV), ease of cleaning facility design and facility cleaning problems.

Your organization are provided comprehensive, hands on, Good Manufacturing Practice (GMP) of your Process Validation, Cleaning Validation and facility cleaning quality and compliance to the pharmaceutical, biotechnology medical device, medicinal cannabis, and cosmetic industry.

Bio Cleaning Consulting have been providing Contamination Control Strategy, Cleaning Validation and Facility Cleaning Consulting Services in APAC for the past decade.

Do you want to be audit-inspection ready for CCS, CV, equipment cleaning and facility cleaning? Why not ask us how we can help analyze and develop remediation for you.

Bio Cleaning Consulting has the experience and expert capability to deliver wide range of technical services for your organisations.

Our Service Portfolio

Audits

Long-established Contamination Control Strategy and Cleaning Validation and facility cleaning programmes often become tired over time, which is reflected by declining quality, and cleaning standards. The first step in evaluating existing CCS and CV provisions is to know where you stand now, this requires a systematic review of all aspects of your Risk Assessments, Governance, Subject Matter Experts (SME’s), cleaning processes and execution, including specifications, instructions, and operations (workflow studies). To do that you need to have someone completely independent of all parties to give an honest and unbiased assessment.

Bio Cleaning Consulting will:

  • Conduct independent site inspections of current process.
  • Conduct systematic reviews of your CCS, CV, Cleaning systems and cleaning documentation.
  • Audit existing CCS, CV processes on products and equipment.
  • Conduct workflow review of existing CCS, CV, cleaning operations and risks.
  • Conduct gap analysis and risk assessments.

ANALYSIS

While working close with you in reviewing your current CCS, CV and facility cleaning meeting the regulatory requirements, we analyze your workplace and cleaning validated state to identify any gaps and risks.

Bio Cleaning Consulting will:

  • Conduct a Gap Analysis of existing CCS, CV and training provisions.
  • Conduct a management support needs analysis – Culture of Quality.
  • Compare current CCS, CV cleaning systems against industry best practice benchmarks.
  • Conduct risk analysis.

DESIGN

Everything Bio Cleaning Consulting do is completely focused on providing you with optimal and measurable performance. Whether it is routine equipment cleaning operations, facility cleaning or specific and highly unique cleaning systems, being results-oriented ensures that optimal performance is always front and centre.

Bio Cleaning Consulting will:

  • Create results-focused CCS, CV systems that are defensible under data integrity.
  • Define specific, simple, measurable and realistic continuous / continued process verification.
  • Create specific and unique processes and cleaning systems, with Continuous Improvement in mind.
  • Create targeted training and coaching programmes for operators, management, and executives.

DOCUMENTATION

To ensure the entire equipment cleaning and facility cleaning operations are run at optimal effectiveness and run at that level day after day continuously, detailed documentation is created.

Bio Cleaning Consulting will:

  • Assist with the review and creation of policies, guidelines, governance documentations.
  • Assist with the review and creation of cleaning standard operations procedures specific to the area of interest.
  • Assist with the review and creation of cleaning staff and management training documentation.
  • Assist with the review and creation risk assessments, gap analysis covering workplace cleaning operations and risk to the organisation.

EXECUTION

The implementation of CCS, CV systems is just as important as the creation of those systems. The roll-out needs to be managed to reduce disruption and to ensure all staff are fully onboard with the changes. Quality and key performance indicators (KPI’s and Quality Checking Systems) are tightly integrated into the cleaning systems, to ensure cleaning standards are continuously met and the workflow is at optimal performance.

Bio Cleaning Consulting will:

  • Deliver onsite consulting and training of operators, managers and executives.
  • Provide roll-out implementation.
  • Create and implement performance indicators and quality checking systems.

SUPPORT

Bio Cleaning Consulting does not stop once every aspect of the work has been completed, Bio Cleaning Consulting would ensure the cleaning operations maintain a high level of optimal performance in the months after roll-out.

Bio Cleaning Consulting will:

  • Deliver onsite post-training assessments (quarterly, semi-annually, or annually).
  • Provide CCS and CV cleaning operations assessments.
  • Provide continued operation and management support.
  • Provide training refreshment and updating skills

How can Bio Cleaning Consulting help you