From 14 to 18 January 2019, experts from the Cuban regulatory body CECMED conduct a final audit of the Instituto Latinoamericano de Biotecnología MECHNIKOV production site for compliance with GMP requirements and standards. Prior to the final audit, the MECHNIKOV specialists did a great deal of work in December. So, from December 3 to December 7, 2018, they performed the MFT batches (media fill test is a process simulation testing which is carried out in the same manner as that of normal production except that an appropriate microbiological growth medium is used in place of the drug).
During the filling process of three MFT batches, the sterility and microbiological purity of the filling process was confirmed. After filling, appropriate samples of the primary packaging were taken for control. The results obtained on December 17-21, 2018 confirmed the absence of endotoxins and the microbiological purity (sterility) of the samples of all three MFT batches. On December 16-18, 2018, the filling of the validation batches of the influenza was carried out at the MECHNIKOV site (the vaccine had been delivered in bulk from SPbSRIVS).
The results of quality control for the filling of the validation batches were obtained on January 3-5, 2019, and confirmed the absence of endotoxins and microbiological purity (sterility). According to the definition suggested by the WHO, good manufacturing practice (GMP) is “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.”
GMP rules apply to all aspects of the manufacturing process, including the following: specified manufacturing process; the most important validated technological stages; production and storage facilities and vehicles that meet the established requirements; qualified and professionally trained production personnel and quality control personnel; adequate laboratory services; approved written procedures and instructions; record-keeping for all stages of the established procedures; fully supervised product manufacturing process using the workflow for tracking product batches and logs for the distribution of finished products; and product recall and complaint handling systems. The guiding principle of GMP is embedding the quality in the manufacturing process of a product, rather than merely checking it while testing the finished product. Therefore, the manufacturer ensures that the product meets the final specifications and that the technology, including the operating conditions, remain the same throughout the production cycle.
