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GMP Certification

GMP Certification

Experience a seamless blend of Implementation, Consulting, Auditing, and Certification services all under one roof. Our passionate team is devoted to propelling your business to unparalleled success.

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GMP, or Good Manufacturing Practice, is a globally recognized standard for overseeing the control and administration of pharmaceutical manufacturing, testing, and overall product quality. It establishes specific guidelines outlining the approach to quality assurance. The certification in GMP ensures that products are manufactured in alignment with rigorous quality standards.
The GMP requirements are not rigid; instead, they are flexible and straightforward to implement. Moreover, these requirements empower manufacturers to determine the most effective way to implement the necessary controls.
Prerequisites for GMP Certification include the regulation of manufacturing facility design, equipment and machinery design, procedures and operational principles, as well as environmental conditions. Manufacturing practices and processes, encompassing health and safety, maintenance, and other aspects, must be explicitly defined, validated, and controlled to ensure uniformity and adherence to specifications.
Operators involved in production, quality assurance/quality control, logistics, factory management, and product control throughout the manufacturing process should be knowledgeable, trained, and competent. Additionally, meticulous records must be maintained for manufacturing, quality control, and logistics, demonstrating adherence to defined procedures and instructions.
According to regulatory requirements, these records should be retained for a period of 5 to 10 years, covering aspects from manufacturing to quality control and logistics to ensure compliance throughout the supply or sale process.

GMP Certification

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.

GMP Certification Process

  1. Application Submission:
    • The initial step involves submitting an application that includes fundamental company information.
    • The certification authority reviews and approves the application, recording all data in the GMP database.
  1. Application Assessment:
    • A panel reviews the application to ensure it meets consistency requirements.
  1. Analysis and Agreement:
    • Following a document audit, a value citation is provided for a Gap Analysis, covering all quality rule provisions and areas.
    • The Gap Analysis evaluates the organization’s task organization and completion.
  1. Document Examination:
    • Thoroughly examine the organization’s documentation to ensure compliance with requirements.
  1. Stage-1 Audit:
    • Audit the documented approach and strategies to determine consistency requirements.
    • Conduct a poll to review the administration structure documentation for consistency.
  1. Stage-2 Audit:
    • Verify the organization’s operations based on documentation.
    • Identify non-compliances, allowing for correction.
    • Evaluate the execution technique according to the report.
  1. Corrective Action:
    • Take corrective action if any dissimilarity is found.
  1. Double-Check:
    • Representatives double-check work instructions and the documented approach and strategies before overseeing the execution process.
  1. Certification Issuance:
    • The Certification Body issues a compliance certificate, valid for an extended period.
  1. Surveillance Audit:
    • Conducted every six months or one year post-certification to ensure ongoing compliance with administrative framework requirements.
    • The surveillance audit confirms the organization’s adherence to GMP standards.

GMP Certification cost

The expense associated with GMP certification, as outlined by the Food and Drug Administration, is contingent on the company’s size. For companies with fewer than 20 employees and those with more than 20 but fewer than 500 employees, the cost of certification is typically determined based on the size of the company.

Adherence to Regulatory Standards

GMP or cGMP certification signifies that the facility/company/organization is following guidelines set by organizations such as WHO or FDA, as well as meeting local nationalized standards and guidelines.

Hygiene and Cleanliness Standards

Ensures maintenance of hygiene and cleanliness standards throughout the manufacturing and logistics chains.

Good Documentation Practices

Implementation of good documentation practices, including well-documented manuals, procedures, standard operating procedures, operational controls, risk assessments, and regulatory compliances.

Comprehensive Coverage

Applies to the design and operation of Medical Devices, IVD products/items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items, covering management of processes and products.

Personnel Competence

Demonstrates and establishes personnel competence, including technical competence.

Handling Non-Conformities and Complaints

Establishes the organization's system for dealing with Non-Conformities and Complaints, ensuring proper reporting to Regulatory bodies when necessary.

Cost Reduction and Resource Utilization

esults in cost reduction and optimal resource utilization.

Proof of Product Quality

Serves as proof of delivering safe and high-quality products and items.

ISO 14001 Certification

BENEFITS OF ISO 14001 Certification iN SINGAPORE

ISO 13485 Certification

Regulatory Compliance

Ensures compliance with all international, national, and local regulations.

Enhanced Customer Assurance

Increases customer assurance, rapport, and trust.

International Market Entry

Facilitates entry into international markets by meeting recognized standards.

Professional Organizational Culture

romotes a professional culture within the organization.

Reduction in Issues and Claims

This leads to a decrease in complaints, fines, product returns, re-processing, rejections, non-conformities, and claims.

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How to Obtain GMP Certification?

Certease serves as a comprehensive platform to address your legal and financial requirements, connecting you with trusted professionals. Our clients express satisfaction with our legal services, consistently rating us highly and offering regular updates due to our commitment to simplifying legal processes.

Throughout the GMP Certification process, our clients can easily monitor progress on our platform. If you have inquiries about the certification process, our knowledgeable representatives are just a phone call away. Certease ensures that your interactions with professionals are not only efficient but also enjoyable. For additional details and information, please visit our official website at www.certease.com

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