Operon strategist provide consultancy for ISO 15378 Certification

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ISO 15378 Certification consultant Services
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• ISO 15378 certification is a quality assurance
  for primary packaging materials for medical
  products specific prerequisites for the
  utilization of ISO 90012008, with reference to
  GMP.
• In 2006, the procedure-oriented iso 15378
  standard was delivered. In view of the globally
  acknowledged ISO 9001 quality standard, it
  contains all the GMP essentials appropriate to
  primary packaging material, for example, batch
  tracing, risk management, validation, and
  controlled environment.

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What is ISO 15378 Certification?

• SO 153782017 standard indicates requirements for
  a quality management system where an organization
  needs to show its capacity to give primary
  packaging materials for medicinal products, which
  reliably meet customer requirements,
  including regulatory requirements and
  International Standards relevant to primary
  packaging medicinal materials
• An ISO 153782017 certificate with its wholistic
  way to deal with GMP and quality necessities, is
  perceived all through the world. It delivers
  manufacturers of primary packaging materials with
  an appropriate capability for customer approval
  just as improving the organizations image
  according to the authorities. ISO 153782017
  applies to all manufacturers of packaging
  materials that come into direct contact with the
  medical products. The standard covers all the
  typical materials, such as glass, rubber,
  aluminum, and plastics.

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ISO 15378 Benefits

• The manufacturer can improve their proficiency of
  production processes by following GMP standards
  according to ISO 15378 standard.
• To relieve your risks particularly identified
  with product contamination, mix-ups and errors
  and ensure product efficacy and shelf life.
• Assurance of quality products to your clients.
  Upgrade customer satisfaction.
• Competitive Advantage over other non- confirmed
  providers.
• Application of risk management helps to reduce
  errors associated with the product.

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Application of ISO 15378

• ISO 153782017 is an application standard for the
  structure, manufacture and supply of primary
  packaging material for the medicinal product.
• It is additionally appropriate for certification
  purposes of primary packaging material for
  medicinal products in pharmaceuticals and medical
  device industries. This primary packaging
  standard discovers Good manufacturing practice
  (GMP) standards and Quality Management System
  relevant to primary packaging materials for
  medicinal products.
• ISO 15378 can be utilized for quality
  improvement, training, auditing and
  certification.
• The ISO 15378 standard is assessed at every 5
  years.

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• Operon Strategist helps manufacturers develop
  their quality management system as per the
  requirements of ISO 15378. We assist with
  documentation, training implementation of the
  quality system.
• We help the Primary packaging material
  manufacturers to understand the requirements of
  ISO 15378 by performing GAP analysis and
  implementing QMS and GMP requirements as per ISO
  153782017.
• We support the manufacturers of primary packaging
  materials for the medicinal product to enhance
  their QMS system by addressing specific
  requirements to meet the quality objectives as
  per ISO 15378 certification.
• We assist the pharmaceutical and medical device
  industries to assess their suppliers of primary
  packaging materials and increase overall product
  quality.

Call / Whatsapp - 9325283428
www.operonstrategist.com
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Thank You. For More Information Contact
Us info_at_operonstrategist.com
Call / Whatsapp - 9325283428
www.operonstrategist.com