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A WHO GMP CERTIFIED COMPANY Brussels Laboratories Pvt. Ltd. Changed, Ahmedabad (Gujarat), INDIA SITE MASTER FILEDocument Number QA/01/01Revision Number01Effective Date01/01/14Review Date31/12/15Page

How to fill out a who-gmp certified company

How to fill out a WHO-GMP certified company?

1. Understand the guidelines: The first step in filling out a WHO-GMP certification is to thoroughly understand the guidelines provided by the World Health Organization (WHO). These guidelines outline the standards and requirements that a company must meet in order to qualify for certification.
2. Conduct a gap analysis: Once you have a clear understanding of the WHO-GMP guidelines, it is important to conduct a gap analysis. This involves assessing your company's current practices and identifying any areas where improvements are needed in order to meet the certification requirements. This analysis will help you create an action plan to address any shortcomings.
3. Develop and implement quality management systems: Quality management systems are a crucial component of a WHO-GMP certified company. These systems ensure that your company operates in accordance with the necessary standards and regulations. Develop and implement robust quality management systems that cover all aspects of your operations, including manufacturing processes, quality control, documentation, and training.
4. Establish good manufacturing practices: Good manufacturing practices (GMP) are a set of procedures and protocols designed to ensure that your products are consistently produced and controlled according to quality standards. Implement GMP in your manufacturing processes to ensure the safety, quality, and efficacy of your products.
5. Implement a strong documentation system: Proper documentation is essential for a WHO-GMP certified company. Ensure that you have accurate and up-to-date documentation for all aspects of your operations, including standard operating procedures, batch records, quality control reports, and supplier documentation. Implement a robust document control system to facilitate easy retrieval, review, and updating of documentation.

Who needs a WHO-GMP certified company?

1. Pharmaceutical manufacturers: Pharmaceutical manufacturers need a WHO-GMP certified company in order to demonstrate their commitment to quality and ensure that their products adhere to international standards. Being WHO-GMP certified enhances the reputation and credibility of pharmaceutical companies, leading to increased customer trust and market access.
2. Contract manufacturing organizations (CMOs): CMOs play a critical role in the pharmaceutical industry by providing manufacturing services to other companies. Being WHO-GMP certified is essential for CMOs as it establishes their capability to meet quality standards and ensures that the products they manufacture on behalf of their clients comply with international regulations.
3. Regulatory authorities: Regulatory authorities, both national and international, require pharmaceutical companies to be WHO-GMP certified in order to approve the marketing and distribution of their products. WHO-GMP certification serves as evidence that a company meets the required quality standards and that its products are safe, effective, and of high quality.
4. Healthcare institutions: Healthcare institutions such as hospitals and clinics rely on WHO-GMP certified companies for the procurement of medicines and medical products. Certification provides assurance that the products they purchase have been manufactured under strict quality control measures, ensuring patient safety and efficacy.
5. Patients and healthcare professionals: Patients and healthcare professionals who prescribe and administer medicines depend on WHO-GMP certified companies to ensure the quality, safety, and effectiveness of the products they use. Being WHO-GMP certified instills confidence in patients and healthcare professionals, assuring them that the medicines they rely on meet stringent quality standards.

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What is a who-gmp certified company?

A WHO-GMP certified company is a pharmaceutical company that has been certified by the World Health Organization for Good Manufacturing Practices.

Who is required to file a who-gmp certified company?

Pharmaceutical companies and manufacturers who produce drugs and medical products are required to file for WHO-GMP certification.

How to fill out a who-gmp certified company?

To fill out a WHO-GMP certification, companies must ensure they meet all the required Good Manufacturing Practices set by the World Health Organization and submit the necessary documentation.

What is the purpose of a who-gmp certified company?

The purpose of a WHO-GMP certified company is to ensure that pharmaceutical companies follow international standards for manufacturing quality and safety of their products.

What information must be reported on a who-gmp certified company?

Information such as manufacturing processes, quality control procedures, storage conditions, and documentation of all production activities must be reported on a WHO-GMP certified company.