• cGMP Guidelines TrainingActions

  • How to apply cGMP guidelines to :
  • 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...)
  • OSD, Sterile, Cannabis, Morphine Processes
  • ATEX 1-3, High Potent 1-5, BSL 1-4 Processes
  • Commissioning & Qualification: FAT/SAT, IOQ
  • Process Validation (CPP, CQA, PCS, CPK), CSVRead more

c-GMP Pharmaceutical Design Engineering :

 

Conformité

  • cGMP Sanitary Design (ASME-BPE) & LAYOUT:
  • Sanitary Process & Clean Utilities Engineering
  • Cleanrooms, HVAC Design, Sizing & Engineering
  • Critical Process & Environmental Parameters
  • 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, CAPA
  • Root Causes Analysis, Remediation Studies
  • Design Review: FMD135/FDA2009, 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, CSV
  • FDA2011 & EMA2015 Process Validation: CPP, CQA, 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.  More details are given @:

    https://drive.google.com/open?id=1mRlqJdSA3m8yjwrg6-AumKYnSWJmiJVv 

    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 Pharmaceutical & Biotechnology Expert performing c-GMP engineering, validation, audits and regulations compliance inspections (PAI) of Biotechnolgy, Pharmaceutical Labs & Morphine & Cannabis 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 Pharmaceutical Consultants and Experts in Biotechnology as well as in Cannabis and Morphine Processes meeting international cGMP requirements, with more than 25 years experience and skills:

    https://drive.google.com/open?id=1JeFgBIQ_-1NpbpvwnX2P_2rqyZrrvJLg

    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, cannabis, morphine, and medical devices projects, which were all successfully completed, including the following as well :

    • Process equipment, clean utilities, pharmaceutical systems and Facility and Layouts Basic Of Design, Detailed Engineering
    • C&Q - Commissioning & Qualification: FAT, SAT, DQ, IQ, OQ, PQ
    • SOPs and Programs Preparation of Operation, Maintenance, Installation, Cleaning, Calibration, Sampling, Commissioning & Decommissioning, GMP Training...
    • Inspection, Pre-Audit, Audit, CAPA, Root Causes Analysis, Investigation & Remediation  plan, Involvement before, during, after inspections 
    • 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, CSV) according to FDA2011 & EMA2015
    • Production and manufacturing, PGK1 & PKG2, Labs, Warehouse Flow, Optimization and Management
    • LAYOUT, Laboratory Set up, Equipment Qualification (FDA2011 & EMA2015), 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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