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Good Manufacturing Practice

 

Good Manufacturing Practice

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In addition to compliance with specific regulations and quality standards, Robinson Healthcare’s manufacturing facility also operates in compliance with Good Manufacturing Practice (GMP).

 

GMP is defined as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.”

 

GMP is a mandatory requirement for facilities engaged in the manufacture of medicinal products, including veterinary medicinal products. For this reason, the section of Robinson Healthcare’s factory that manufactures Animalintex, a licensed veterinary medicinal product, is audited for compliance to GMP by the Veterinary Medicines Directorate. The same principles of GMP are applied throughout the remainder of the facility. Even though there is not a mandatory requirement for GMP for medical devices and personal healthcare products, this further demonstrates Robinson Healthcare’s commitment to high quality manufacturing.

 

The underpinning principles of GMP are similar to, but more demanding than those required for BRC Global Standards:

 

  • Quality Management System – documented and effective
  • Trained Personnel – suitably qualified and continual training
  • Premises & Equipment – built and maintained to suit the operation, correctly cleaned, using calibrated equipment and entry by unauthorised personnel prevented
  • Documentation – clearly and unambiguously written specifications, instructions, procedures and records
  • Production – performed by trained and competent personnel with any deviations approved and documented, plus avoidance of any contamination and regular validation of product to specification
  • Quality Control – full and independent systems at all stages of production
  • Complaints and Product Recall – effective review of all complaints and a recall system that can be initiated promptly
  • Internal Audits – conducted regularly by designated competent personnel

 

Robinson Healthcare makes certification available at all times and invite customers to inspect their current status directly with any of the conformance assessment bodies above.

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