ISO 15378-Primary packaging materials for medicinal products

ISO 15378:2015 identify necessities for a quality management system where an organization requirements to demonstrate its capability to give primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.

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Occupational Health safety

OHSAS 18001

Meet quality objectives for your primary packaging materials for medicinal products

Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, aluminium containers/components, films, foils and laminate containers. As these materials come in direct contact with medicinal products, they need to comply with safety, efficacy and reliability requirements. Suppliers of primary packaging materials have to meet the expectations of medicinal product manufacturers and demonstrate compliance with expected quality levels by integrating quality management systems (QMS) and good manufacturing practice (GMP) in their production processes.

Benefits of ISO 15378:2015 Certification
  • Decrease and control of risks
  • Presentation of the company's expertise
  • Creation of competitive advantages
  • Time and cost savings
  • Evidence of compliance with statutory regulations and contractual agreements
  • Development of the quality ability
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Management System Standards

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Inspection & Technical Services

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Training & Capacity Building

Organic Certification

It is an accredited process for producers of organic food and other agricultural products. The primary purpose and intention of this certification is to assure quality of product and prevent fraud before sales. That is why demand for this certification is growing day by day globally.

HALAL Certification

Halal is an Arabic term, it is an object or an action which is permissible to use, according to Islamic law. The term covers and designates not only food and drink as permissible according to Islamic law, but also all matters of daily life.


Product Certification

product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.


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Students and fresh engineers of Mechanical, Electrical, Metallurgical, Chemical, Food Technology and Microbiologists, whether you are a recent graduate, working with Smartedge could be a challenging and rewarding next step in their career.

Clients


HCL Systems

GSR

Geosol

DesireES

Fortech

JEK

Jindal Stainless Steelway

ABIR

Ranka

CPHTT

ABCS

ECS

Synergy

XSILICA

BMM

Kirloskar

PCBL

PKV

Reliance Industries Ltd

TATA

Thermal Ceramics

Vijaya Diagnostic Centre

Nagarjuna Group

Wisdom

Novotel

Wavecrest

Genex

Nuzen

Turbo Engineering Services

Ratna-Constructions

Sitacorp

Kapil

Suja-Cafe

Suntech

NSLS

Sevehills

Meritus

Clinexa

JR

CallidusCloud

Invesco

BiologicalE

Technical Services

1)Refractory Management Practices
2)Technical Services- Cold Rolled Steel Manufacturing Services


Inspection Services

Do you need assistance in assuring your product quality as per the agreed specification before your product is being shipped?

Audit Services

Safety Audits, Supplier Audits, Outsource Management System Audits