60. Filling should be carried out as soon as possible following production. Containers of bulk product prior to filling should be sealed, appropriately labelled and stored under specified conditions of temperature. 61. There should be a system to assure the integrity and closure of containers after filling. 62. The capping of vials containing live biological agents must be performed in such a way that ensures that contamination of other products or escape of the live agents into other areas or the external environment does not occur. 63. For various reasons there may be a delay between the filling of final containers and their labelling and packaging. Procedures should be specified for the storage of unlabelled containers in order to prevent confusion and to ensure satisfactory storage conditions. Special attention should be paid to the storage of heat labile or photosensitive products. Storage temperatures should be specified. 64. For each of production, the yield of product should be reconciled with that expected from that process. Any significant discrepancies should be investigated. Quality control 65. Inprocess controls play a specially important role in ensuring the consistency of the quality of biological medicinal products. Those controls which are crucial for the quality (e.g. virus removal) but which cannot be carried out on the finished product, should be performed at an appropriate stage of production. 66. It may be necessary to retain samples of intermediate products in sufficient amount and under appropriate storage conditions to allow repetition or confirmation of a batch control. 67. may be a requirement for the continuous monitoring of data during a production process, for example monitoring of physical parameters during fermentation. 68. Continuous culture of biological products is a common practice and special consideration needs to be given to the quality control requirements arising from this type of production method.
60. Filling should be carried out as soon as possible following production. Containers of bulk product prior to filling should be sealed, appropriately labelled and stored under specified conditions of temperature. 61. There should be a system to assure the integrity and closure of containers after filling. 62. The capping of vials containing live biological agents must be performed in such a way that ensures that contamination of other products or escape of the live agents into other areas or the external environment does not occur. 63. For various reasons there may be a delay between the filling of final containers and their labelling and packaging. Procedures should be specified for the storage of unlabelled containers in order to prevent confusion and to ensure satisfactory storage conditions. Special attention should be paid to the storage of heat labile or photosensitive products. Storage temperatures should be specified. 64. For each of production, the yield of product should be reconciled with that expected from that process. Any significant discrepancies should be investigated. Quality control 65. Inprocess controls play a specially important role in ensuring the consistency of the quality of biological medicinal products. Those controls which are crucial for the quality (e.g. virus removal) but which cannot be carried out on the finished product, should be performed at an appropriate stage of production. 66. It may be necessary to retain samples of intermediate products in sufficient amount and under appropriate storage conditions to allow repetition or confirmation of a batch control. 67. may be a requirement for the continuous monitoring of data during a production process, for example monitoring of physical parameters during fermentation. 68. Continuous culture of biological products is a common practice and special consideration needs to be given to the quality control requirements arising from this type of production method.
consult-manuf-automatic-adoption-pics-130529-pe009-10-annexes.docx