1. GMP Quality Certification: Good Manufacturing Practice (GMP) certification is an international standard designed to ensure the production of various products, such as pharmaceuticals, food, medical devices, and other products, with high quality and precision according to globally recognized standards.

• About the Standard: GMP is a system that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production process that cannot be eliminated through testing the final product. GMP covers all aspects of production, from raw materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for every process that could affect the final product's quality. There must be systems in place to provide documented proof that the correct procedures are consistently followed at every step in the manufacturing process—every time a product is made.

• Benefits of Good Manufacturing Practice (GMP):

  • Ensuring compliance with legal requirements.

  • Reducing the likelihood of facing penalties.

  • Meeting customer requirements more quickly.

  • Raising awareness of production safety among employees.

  • Producing products with maximum precision under appropriate conditions and delivering them to users.

  • Enhancing the company’s reputation as reliable in the public eye.

  • Creating a competitive advantage in international trade. GMP certification helps companies enter international markets, where such certifications are key to product acceptance.

  • Ensuring that all production stages are followed, and products are delivered to users in a highly hygienic manner.

  • Keeping relevant processes and personnel under control to prevent confusion and errors during production.

  • Gaining a competitive edge in the market over competitors.

  • Increasing employee motivation and fostering commitment to the company.

  • Improving manufacturing processes and increasing efficiency.

• How to Implement a GMP System: The best way to establish a GMP system, which is developed to define production standards for companies producing food, pharmaceuticals, medical products, and cosmetics, is by consulting with a certification body.

GMP is recognized as a standard that includes preventive measures regarding the internal and external conditions of the organization to prevent or minimize the likelihood of product contamination from internal and external sources. This practice is an essential method in the production and distribution of food products and a series of techniques that must be continuously applied during the raw material, processing, product development, production, packaging, storage, and distribution stages to ensure product quality.

• Simplified Steps for Implementing GMP:

  1. Define the company's administrative structure and business activity.

  2. Establish the organizational structure and staff qualifications.

  3. Conduct feasibility studies.

  4. Prepare workflow diagrams and application instructions to define work processes.

  5. Prepare documentation related to GMP standards.

  6. Prepare documents related to hygiene and sanitation.

  7. Set procedures for environmental control and production monitoring.

  8. Determine machinery, equipment, and raw materials used in production.

  9. Monitor business processes and make necessary changes.

  10. Establish storage, shipping, and product distribution conditions.

  11. Ensure reporting of non-conforming products and establish error correction methods.

  12. Create a system for receiving and resolving customer complaints.

  13. Set procedures for recalling products when necessary.

  14. Determine how internal and external inspections will be conducted.

  15. Conduct compliance studies after completing all steps.

• Conditions for Obtaining GMP Certification:

  • The company must be formally established and legally compliant, with a trade registry, operating license, or legal entity.

  • Adherence to the latest version of the GMP standard requirements.

  • A documented and reliable management system.

  • Training and qualifying the workforce to professionally apply GMP standards and fully understand international requirements.

  • The company’s ability to correct errors and implement measures to prevent recurrence by identifying root causes of issues through an internal review team.

  • The company’s successful completion of an external audit, or “field inspection,” without major non-conformities, leading to a recommendation for GMP certification.

  • Submitting an application for GMP certification to a certifying body, which must be accredited and internationally recognized.

• Entities Eligible for GMP Certification:

  1. Food Industry Establishments: Companies manufacturing food and beverages intended for human consumption.

  2. Pharmaceutical Industry: Companies that manufacture and distribute pharmaceuticals and medicinal products.

  3. Medical Product Manufacturers: Companies producing medical products, such as medical devices and equipment.

  4. Cosmetic Manufacturers: Companies producing cosmetics must obtain GMP certification to ensure product quality and safety.

  5. Health Organizations and Hospitals: For health organizations and hospitals involved in manufacturing or distributing medical products, GMP compliance is essential.

  6. Regulatory and Administrative Bodies: Regulatory and administrative authorities that set regulations and standards to ensure GMP compliance may sometimes need to obtain GMP certification.

• Procedures for Obtaining GMP:

  1. Employee Awareness and Training: Employees are trained on GMP requirements through workshops, seminars, and training courses to ensure full understanding of the standard’s objectives and the roles they need to execute.

  2. Internal Audit Team Qualification: The internal audit team is trained to conduct audits and examine the organization’s quality system, contributing to better implementation and compliance with the standard.

  3. Creation of Quality System Documentation: This step involves establishing quality policies, vision, mission, and objectives, and creating detailed procedures and instructions necessary for implementing the organization's quality management system.

  4. Final Implementation: This stage involves performing tasks according to the documents and work instructions prepared and conducting internal audits to ensure compliance with the standard’s requirements.

  5. External Audit and Certification: An external audit is requested to review the organization's quality system to ensure it complies with the standard's requirements, after which the certificate is awarded if all requirements are met.

• GMP Standard Requirements:

  1. Establishing Committed Policies and Objectives: Organizations need to establish policies aligned with GMP standards and set specific objectives to support and enhance these policies.

  2. Risk Assessment: Organizations must periodically analyze and assess manufacturing risks to identify weaknesses and develop strategies to address them.

  3. Establishing Procedures and Mechanisms: Organizations must develop precise procedures and effective mechanisms to manage manufacturing quality and ensure consistent and organized implementation.

  4. Implementation: This stage involves efficiently and effectively applying the defined policies and procedures for the manufacturing quality management system.

  5. Legal Compliance: Organizations must comply with all relevant local and international manufacturing laws and regulations and ensure complete adherence.

  6. Continuous Review: Organizations should conduct regular and ongoing internal and external reviews of their management system to ensure effective performance and continuous improvement.

• Strong Steps for Achieving GMP Compliance:

  1. Submit an application for GMP certification.

  2. Conduct a two-stage audit of the organization’s management system, reviewed by certified auditors.

  3. Hold opening and closing meetings to ensure the audit plan’s accuracy and address any organizational difficulties.

  4. Write a comprehensive audit report and submit it to the certification committee for review.

  5. Notify the organization of the certification process results and final observations.

  6. Implement and review necessary corrective measures.

  7. Issue the certification after confirming that corrective measures have been successfully implemented.

  8. Implement periodic monitoring of the organization’s management system by expert teams to evaluate implementation and control effectiveness.

• Validity Period of GMP Certification: GMP certification is valid for three years, with periodic audits conducted during this period to ensure the continued application and effectiveness of the quality management system. The audits over the three years are divided as follows:

  1. First Year Audit: This audit involves an initial review of documents, records, and the organization’s scope of work to verify compliance with GMP requirements.

  2. Second Year Audit: This involves a regular audit to ensure the system’s continued application and effectiveness, reviewing the organization’s processes, evaluating performance improvements, and any updates made.

  3. Third Year Audit: Another regular audit is conducted to ensure the effective continuation of the quality system and evaluate the effectiveness of corrective and preventive measures taken.

After the three-year period, the organization must renew the GMP certification by undergoing a new round of audits and reviews according to updated requirements. This includes updating documents and ensuring the continued implementation of the system, which involves additional financial costs.

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SIFC is a trusted partner for organizations in their journey to obtain various ISO accreditation and quality certificates. We offer specialized consulting services to help these organizations understand the requirements of the needed certificate and implement the correct practices to achieve it. The company relies on a team of quality management experts accredited by IRCA, who have the experience and knowledge to help government agencies, institutions, factories, banks, and others maximize the benefits of obtaining the certificate. With a constant focus on providing innovative and results-oriented solutions, SIFC ensures the successful completion of all qualification stages, from gap analysis, system development, documentation, error correction, awareness, and training, to internal review, external audit, and obtaining the recognized international certificate and enhancing the organization’s profile in the international accreditation forum.