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Validation and regulatory compliance

DOCUMENTED COMPLIANCE, YOUR QUALITY ASSURANCE

 

The pharmaceutical, biotechnology and veterinary sectors, as well as pharmaceutical ingredient production sites (APIs) must meet strict standards to demonstrate that their facilities and products meet quality standards and Canadian, US, European or global good manufacturing practices (GMPs).

 

The natural products, nutraceutical, or agri-food industries must also apply rules established in Canada and the United States.

 

Thanks to our in-depth knowledge of current regulatory frameworks, GCM Consultants is your partner of choice for completing your validation process.

 

 Validation and regulatory compliance

 

Whether you are a plant manager or a validation and quality manager, you need to be sure that your new or existing plant is running smoothly and optimally and that your production meets the prescribed standards while staying within your operating budget.

 

This is where GCM’s validation expertise comes into play. With the support of our engineers and industry specialists to qualify your installations, operations, and their performance, you benefit from personalized validation support from the beginning of the project and a flawless preparation for audits in order to meet the highest quality assurance standards.

Experts to ensure the quality of your installations and production

When it comes to validation, GCM Consultants is an engineering firm that sets the bar high. For us, the compliance of installations is a question of know-how, experience, and rigour.

 

Our experts ensure compliance with the requirements of various international regulatory bodies such as Health Canada, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMEA).

 

Whatever your industry, our specialists have the advanced expertise needed to qualify your various facilities, utilities, and equipment, as well as your operations. They can advise you with discretion and prepare your validation documentation with great attention to detail.

 

 

DOCUMENTATION

 

DOCUMENTATION

 

  • URS (User Requirement Specification)  
  • FS (Functional Specification) 
  • DS (Design Specification) 
  • VMP (Validation Master Plan)
  • FAT (Factory Acceptance Test)
  • SAT (Site Acceptance Test)
  • IQ, OQ, PQ (Installation, Operational and Performance Qualification)
  • SOP (Standard Operational Procedure)
  • Qualification and validation reports

 

 

SERVICES

 

 

  • Project management
  • Schedule and planning
  • Commissioning, Decommissioning
  • Preparation and execution of qualification protocols for equipment, process, utilities, and installations
  • Training
  • Audits
  • Maintenance

 

 

SECTORS

 

SECTORS

  • Medicinal products for human use: injectables, vaccines, tablets, creams, liquids, medical instruments, etc.
  • Natural products
  • Laboratories
  • Veterinary Products
  • API

 

 

EQUIPMENT / SYSTEMS

 

EQUIPMENT / SYSTEMS

  • Fermenter, bioreactor, wrapper, lyophilizer, granulation, compression, etc.
  • Clean rooms
  • Biological containment
  • Sterile and aseptic environments
  • Conditioning, packaging, storage, and handling
  • Clean services (gas, water, steam, air, etc.)
  • Heating, ventilation, and air conditioning (HVAC)
  • Industrial ventilation, dedusting
  • Cleaning and sterilization in place (CIP, SIP)
  • Automation
  • Computer systems and networks
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