Re-Certification of Good Manufacturing Practice (GMP) standards of PT IPB Shigeta Animal Pharmaceuticals
PT. IPB Shigeta Animal Pharmaceutical had obtained the Good Standing Certification for the Good Manufacturing Practice (GMP) standards of the animal medicines producer (CPOHB) on 30 May 2011, and this certificate is valid for five years, up to 30 May 2016. For the renewal of this certification, then on 26-27 May 2016, as assigned by Director of Animal Health in his letter No. 02 041/TU.040/F.4/05/2016 dated 2 May 2016, the Animal Health inspectors had inspected production facilities of veterinary medicines manufacturer PT IPB Shigeta Animal Pharmaceuticals, at Faculty of Veterinary Medicine (FKH IPB) campus, Jl. Agatis, Darmaga Campus, Bogor.
CPOHB a veterinary medicines manufacturer standards that must be obtained by a veterinary medicines manufacturer in Indonesia. Director of PT. IPB Shigeta DVM. Kamaluddin Zarkasie, PhD, and Dr. Widiyanto Dwi Surya, MSc, were very grateful for the smooth process CPOHB certification on 26-27 May 2016. The audit process lasted for two days, and the first agenda in the first day was review of the production facilities of PT. IPB Shigeta by the Assessment Team of Ministry of Agriculture Republic of Indonesia consisted of DVM. Bahruddin Syahroni, M.Sc., DVM. Ni Made Ria Isriyanthi, PhD., and DVM. Liys Desmayanti. Agenda for the second day Assessment Team was assessment of the documents related to quality system.
Implementation of quality systems in the production unit of PT. IPB Shigeta, both in, Bogor and Surabaya have been carried out according to the standardized procedures strictly. Therefore, the Assessment Team the Ministry of Agriculture had only evaluated the implementation of CPOHB by for PT.IPB Shigeta, they only check the shortcomings of the processes. However, PT IPB Shigeta has prepared anything regarding to the Good Manufacturing Practice (GMP) standards for six months, including training of employees, experts consultation, procedural system improvement, and the environment evaluation and administration improvement.
CPOHB certification is really required by PT IPB Shigeta as this company is committed to implement its standardized GMP. It is defined as the part of Quality Assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use. nforce the quality policy as an AI vaccine manufacturers Reverse Genetic quality. PT IPB Shigeta is joint venture between IPB and Japanese company, it is the only manufacturer of inactivated H5N1 AI vaccine in Indonesia using reverse genetics technology. The trade name of such vaccine is Bird Close 5.1. PT IPB Shigeta cater the needs of commercial layers and breeding farms for the protection of their products. In the near future PT IPB Shigeta planned to produce other vaccines, namely Bird Close-ND combination of AI and ND Bird Clode. (Wied)
