Pharmaceutical manufacture storage

Packaging, storage and transport 4 Guide to Good Pharmaceutical Manufacturing Practice... 

Cleaning of product contact surfaces such as reaction and storage vessels is an important aspect of pharmaceutical manufacturing. Residual materials are contaminants and may provide fertile grounds for microorganisms to grow. 

It has been proved in several research papers that water is the most important factor in the component s degradation of ORSs. To proceed with the study, the pharmaceutical formulation was prepared by a pharmaceutical manufacture. The batch was packed in six types of packaging material. After storage of samples for 36 weeks maintained at ambient temperature, at ambient temperature and 76% relative humidity, and at 40°C with 80% relative humidity, analyses of water determination were made at different intervals of time. Water determination was performed by loss on drying at 50°C and Karl Fisher methods. 

The national health and drug regulatory authorities should ensure that all pharmaceutical products subject to their control conform to acceptable standards of safety, efficacy and quality, and that all premises and practices employed in the manufacture, storage and distribution of these products comply with good manufacturing practice (GMP) standards so as to ensure the continued conformity of the products with these requirements until they are delivered to the end-user. 

The complexity of biological macromolecules when compared with small molecule therapeutics, differences in manufacturing, and the broad variety of potential degradation pathways lead to special requirements in quality assurance and analytical testing of pharmaceutical proteins. The product-related impurities are molecular variants formed during manufacture, storage, or use, and their properties are different from the desired product with respect to activity, efficacy, and safety. 

Licensure requirements for manufacture, storage, distribution, and dispensing of pharmaceuticals... 

There are doubts regarding the long-term integrity of storage media (magnetic tapes, floppy disks and even compact disks) that contain records associated with pharmaceutical product development and analysis. The possibility that these media could lose data is of great concern to the regulatory authorities. It is therefore an issue that pharmaceutical manufacturers must address as part of the LIMS infrastructure implementation. Periodic restoration of data verifies that the data are intact and confirms the restore procedure is operable. 

Despite extensive research and advancement in this area, application of ASD technology has not gained widespread use in the pharmaceutical industry, and still remains a niche technology applicable only to small number of compounds. The primary reasons for this reluctant adoption can be attributed to fear over the inherent physical instability of the amorphous material during manufacturing, storage, and dissolution, as well as lack of accessibility of robust and commercially viable manufacturing facilities. 

This chapter has been written in order to investigate natural polysaccharides in terms of their use as pharmaceutical excipients. The focus has been given to the chemical structure of natural polysaccharides, which is of paramount importance for their utilization in drug delivery systems during stages of manufacturing, storage and human intake. 

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