Jul . 23, 2024 11:03 Back to list
From June 8, 2024 to June 9, 2024, the Kenya official team came to Shimu Group for GMP inspection. The inspectors were from the Veterinary Medicines Directorate (VMD). This is an Agency of the Government of Kenya with the mandate of regulating veterinary medicines.
The laws of Kenya require that a veterinary medicine must be registered before it is placed in the market and compliance with GMP is one of the pre-registration requirements. Because products manufactured in our factory are in the Kenya market, so the inspection must be conducted.
During this inspection, the two parties communicated about this inspection in a friendly atmosphere. On the first day and the second day morning, the Kenya official team reviewed our documents. On the second day afternoon, the Kenya official team reviewed facilities. They had given document review more time than the tour of facilities. This is because they wanted to understand how we had established our Quality Management System (QMS) and whether its objectives meet the requirements of the World Health Organization (WHO) cGMP standards.
During this inspection, the Kenya official team carried out the inspection together with our technical team (QA, QC and Production Heads) by going through the tour of facilities and questionnaire section by section. Our technical team answered the inspectors' questions and provided additional documents. This inspection to be a cordial exercise, the inspectors and our technical team were patient with each other.
Passing the Kenya GMP inspection is an affirmation of the effective operation of the company's quality management system, indicating that the company's quality management system meets the GMP quality standards. This successfully passing of the inspection is due to the sufficient preparation in the early stage and the cooperation of all departments. This inspection not only fully demonstrated the professionalism of the company's employees, but also fully demonstrated the company's comprehensive strength. Through this inspection, we have improved our shortcomings and better served our global customers.
Products categories
Jul . 23, 2024 11:02 Back to list
From June 8, 2024 to June 9, 2024, the Kenya official team came to Shimu Group for GMP inspection. The inspectors were from the Veterinary Medicines Directorate (VMD). This is an Agency of the Government of Kenya with the mandate of regulating veterinary medicines.
The laws of Kenya require that a veterinary medicine must be registered before it is placed in the market and compliance with GMP is one of the pre-registration requirements. Because products manufactured in our factory are in the Kenya market, so the inspection must be conducted.
During this inspection, the two parties communicated about this inspection in a friendly atmosphere. On the first day and the second day morning, the Kenya official team reviewed our documents. On the second day afternoon, the Kenya official team reviewed facilities. They had given document review more time than the tour of facilities. This is because they wanted to understand how we had established our Quality Management System (QMS) and whether its objectives meet the requirements of the World Health Organization (WHO) cGMP standards.
During this inspection, the Kenya official team carried out the inspection together with our technical team (QA, QC and Production Heads) by going through the tour of facilities and questionnaire section by section. Our technical team answered the inspectors' questions and provided additional documents. This inspection to be a cordial exercise, the inspectors and our technical team were patient with each other.
Passing the Kenya GMP inspection is an affirmation of the effective operation of the company's quality management system, indicating that the company's quality management system meets the GMP quality standards. This successfully passing of the inspection is due to the sufficient preparation in the early stage and the cooperation of all departments. This inspection not only fully demonstrated the professionalism of the company's employees, but also fully demonstrated the company's comprehensive strength. Through this inspection, we have improved our shortcomings and better served our global customers.
Products categories