• cGMP Guidelines TrainingActions

  • How to apply cGMP guidelines to :
  • Lead successful FDA, Health Canada, EMA, WHO, PIC/s inspections 
  • Layout, HVAC, cleanrooms, functionnal flow review
  • Risk management  (ICH Q9, FMEA & RAPA), APR, C&Q
  • Clean utilities (PW, WFI, Pure steam, PCA, Gas)
  • Pharmaceutical systems (CIP, SIP, RABS, LAF, Isolator, Autoclave, Depyro)
  • OSD, Liquids, sterile & injectable processes
  • ATEX-1@3, High Potent-1@5, BSL-1@4 processes
  • Commissioning & Qualification: FAT/SAT, IOQ
  • Process Validation (CPP, CQA, PCS, CPK)Read more

c-GMP Pharmaceutical Design Engineering :

 

Conformité

  • cGMP Sanitary Design (ASME-BPE2012) & LAYOUT (ISO14644), FDA, HC, EMA :
  • Critical process & environmental parameters
  • cGMP Sanitary Process & Cleanrooms Design & Sizing
  • Sanitary Process Design of Equipment & Clean Utilities
  • Basic & Detailed Engineering :
  • P-URS, PFD, BOD, E-URS, P&ID, V-URS, FDS
  • Workshop Drawings Review & Approval 
  • DQ, Trace Matrix 
  • Layout, Functional Flow :
  • Layout, Equipment Installation
  • Functional Flow Drawing
  • Commissioning, FAT, SAT

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PAI, cGMP Compliance & Design Review, PM, Validation:

  • Pre-Approval Inspection
  • Audit, PAI 
  • QA, Regulatory Affairs, DIN, DEL, MDEL
  • CAPA, Root Causes Analysis, Remediation Studies
  • Design Review' (FMD/FDA 2009), GAPA & RAPA
  • Project Management :
  • Construction, HSE management & Cost Control
  • Risks Analysis (FMEA, ICH Q9, ATEX, RAPA, GAPA) & Mitigation
  • Validation :
  • APR, Cleaning Validation, C&Q, DQ, IQ/OQ
  • FDA2011 & EMA2014 Process Validation (CPP, CQA, PCS, CPK)

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About Us

  • Welcome to Pharma Bio Expert, PBE

    PBE, Pharma Bio Expert Inc. shares in your commitment to quality and understands how critically important regulatory compliance is to the success of your business and to the health and safety of your customers.

    According to Steven S. Kuwahara1 , about 45% of the recalls of drugs and devices are due
    to design problems(1). Risk Analysis in Pharmaceutical Manufacturing: A Regulatory Overview.  Global Compliance Panel Webinar, 25 mai 2010.
     

    PBE is a Leader BioPharmaceutical Expert performing c-GMP audits and regulations compliance inspections (PAI) of Biotechnolgy, Pharmaceutical Labs & Facilities, Hospitals Cleanrooms, Injectable preparation according to USP797, Biomass Conversion, Biorefining Processes and Technologies http://www.groupes.polymtl.ca/crip/en/cont_coords.php. All of these projects involved environmental impact studies and proper treatment technologies in compliance with the applicable regulations and codes : HSE, CNESST (www.csst.qc.ca/), LRQ, MDDELCC (www.mddelcc.gouv.qc.ca/), ATEX, NFPA, OSHA, CSA, ULC standards as well. 

    PBE involves Senior Bio-Pharmaceutical Consultants and experts, who acquired more than 25 years experience and skills.

    PBE experts successfully completed more than 120 projects were successfully completed, involving :

    RAPA (New Approach): Risk Analysis & Preventive Actions

    GAPA (New Approach): Gap Analysis & Preventive Actions

  • Projects

    With more than 25 years of skills and involvement in many Pharma-Biotech compliance projects,  PBE, Pharma Bio Expert Inc. provided efficient consulting services for c-GMP compliance from development through validation for over than 120 projects pharmaceuticals, biotechnology, nutraceuticals, cosmetics, foods, and medical devices projects, which were all successfully completed, including the following as well :

    • SOPs Preparation (operation, maintenance, installation, cleaning, Calibration)
    • Inspection, Pre-Audit, Audit, CAPA, Root Causes Analysis, Investigation & Remediation  plan, .. 
    • Create and Maintain Quality System
    • Quality Assurance and Compliance
    • Batch release
    • GMP, Site and Establishment Licensing
    • Regulatory Submissions, DIN. AMM
    • Validation (cleaning, process, sterlization, computer) according to FDA2011 & EMA2015
    • Production and manufacturing, PGK1 & PKG2, Labs, Warehouse Flow, Optimization and Management
    • LAYOUT, Laboratory Set up, Equipment Qualification (FDA2011 & ANSM 2014), Calibration, and Maintenance
    • Laboratory Safety Training & Management (FMEA, ICH Q9)
    • cGMP Training
    • Translation of technical documents (User’s, maintenance, installation, cleaning manuals), from English to French to English languages
    • Please consult the list of our clients and projects...

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  • Partners

    PBE, Pharma Bio Expert Inc. has developed business partners with several compagnies...

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