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Article February 2023 · Montreal, Quebec

PBE Expert, your GMP compliance partner

A compliance partner does more than review your procedures. Here is what the PBE Expert team brings, from the first drawing to the inspection, and after we leave.

  • WhenFebruary 2023
  • WhereMontreal, Quebec
  • FormatArticle
  • CategoryPublications and videos

Since 2012, the PBE Expert team has supported the pharmaceutical, biotechnology, hospital and food industries. Its experts bring more than 35 years of experience and have completed more than 300 projects that meet FDA, EMA, Health Canada and World Health Organization requirements.

A single point of contact, from design to inspection

Under the EPCMV model, engineering, procurement, construction, project management and validation stay under one roof. Every requirement written at the outset in the user requirements specification (URS) is traced all the way to the evidence that it has been met: fewer intermediaries, fewer deviations discovered too late.

Compliance built in from the design stage

  • Analysis of the requirements, laws and regulations that apply to your product
  • Layout of cleanrooms, flows and pressure cascades (ISO 14644)
  • Clean utilities: purified water, water for injection, pure steam, compressed air
  • Containment of highly potent products (OEL) and biosafety (BSL-2 and BSL-3)
  • Risk management to ICH Q9, using FMEA, from the very first sketches

Qualify and validate, with evidence to back it up

Validation Master Plan, installation, operational and performance qualification, process, cleaning and computerized system validation (GAMP 5), and temperature mapping: every document is written to answer the inspector’s question before it is asked.

Getting ready for the inspection

GMP compliance audits, pre-approval inspections (PAI), gap analyses and corrective and preventive action (CAPA) plans. The team includes a Health Canada scientific expert and a MAPAQ consultant: it knows what inspectors expect from the inside.

Passing on the know-how

As a training organization approved by the Commission des partenaires du marché du travail (No. 0059104), PBE Expert trains your teams hands-on, at your own facilities. The goal: compliance that holds up after we leave.

Who it’s for

  • Pharmaceutical and biotechnology manufacturers: solid, liquid, sterile and injectable dosage forms
  • Vaccines, biosimilars and advanced therapies
  • Hospitals, pharmacies and health centers
  • Medical cannabis and natural health products
  • Food industry and fine chemicals
Next articleConference · October 22–24, 2021PBE Expert attended the first international hemp and cannabis conference, held by AMCUC in Tangier, on the plants’ therapeutic and industrial potential.

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