C E R T E A S E

Loading

visit our location:
Bengaluru
Opening Hours:
Mon-Fri 8am-5pm
Send us mail
contact@certease.com
Phone Number
+91 89517-32523
Get A Quote

GMP Certification

ISO 27001 Certification Information Security Management System (ISMS) JORDAN

We provide the best Services for your GMP Certification.

GMP stands for Good Manufacturing Practice, and the term is used globally to manage the control and management of pharmaceutical manufacturing, testing, and overall quality. It defines certain guidelines that discuss the quality assurance approach. GMP certification ensures that products are produced in accordance with quality standards.

Benefits of having GMP Certification

  • Certifying GMP or cGMP can provide a facility/company/organization with the following benefits, among others: Establishes that the organization is adhering to WHO or FDA guidelines, as well as local nationalized standards and guidelines.
  • Maintains hygiene and cleanliness standards throughout the manufacturing and logistics chains.
  • Documents (e.g., manuals, procedures, standard operating procedures, operational controls, risk assessments, regulatory compliances, etc.) and records for evidence are examples of good documentation practices.
  • Design and operation of Medical Devices, IVD products/items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items, including management of processes and products.
  • Establishes personnel competence (including technical competence).
  • Establishes the Organization’s system for dealing with Non-Conformities and Complaints, including proper reporting to Regulatory bodies as needed.
  • Reduction Cost reduction and best possible resource utilization
  • Proof of Safe and High-Quality Products and Items
  • All international, national, and local regulations must be followed.
  • Increases customer assurance, rapport, and trust.
  • International Market Entry
  • Within the organization, there is a professional culture.
  • Complaints, fines, product returns, re-processing, rejections, non-conformities, and claims are all reduced.

GMP Certification Prerequisites

  • Manufacturing facility design, equipment and machinery design, procedures and operating principles, and environmental conditions must all be controlled.

  •  

    Manufacturing practices and processes, such as health and safety, maintenance, and so on, must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications.

  •  

    Operators should be aware, trained, and competent to carry out production, QA/QC, Logistics, Factory Management, and product control throughout the manufacturing process.

 

  • Records should be kept for manufacturing, quality control, and logistics, demonstrating that all steps required by the defined procedures and instructions have been taken.

 

  • According to regulatory requirements, records should be kept for 5 to 10 years.

 

  • Supply or sale.