Processing and packaging

The primary thmst of GMP is that it is not enough merely to make chemicals to meet USP or other apphcable specifications. The chemicals must be made under clean and sanitary conditions, procedures and processes must be vahdated and documented, and processing and packaging must be carried out under conditions that preclude mixup and mislabeling. Records must be kept of complaints, and the manufacturer must know enough about the storage properties of the products to specify storage conditions and, if necessary, expiration dates on the label. 

Many imported raw spices are processed and packaged in the United States and then exported. Because of strict United States food laws, many foreign purchasers prefer spice available from the United States, whether domestic or imported. Thus imported products may end up as a significant part of the export Hst. 

Fully Processed Foods. Fully processed foods are processed and packaged so that the ambient temperature shelf life can exceed three to six... 

Aseptic Processing and Packaging of Foods, lUFoST Symposium, Tylosand, Sweden, Sept. 1985. 

P. E. Nelson, J. V. Chambers, andj. H. Rodrigue2, eds.. Principles of Aseptic Processing and Packaging The Eood Processors Institute, Washington, D.C., 1987. PackAlimentaire 89 Conference, Schotiand Business Research, Inc., Princeton, N.J., 1989. 

Particular food products have weU-developed technologies associated with their preparation, processing, and packaging. Detailed discussions of processing technologies can be found in the general references. 

In addition, many grades of paper and paperboard are used in direct or indirect contact with foods. Thus, many mills only use paper chemicals that have been cleared for use by the U.S. Pood and Dmg Administration (PDA) (3), so that it is not necessary to segregate machine broke (off-grade paper and edge clippings that are reclaimed for their fiber value) and white water. Most of the chemicals discussed in this article are approved by the PDA for use in paper and paperboard that are intended for appHcations in food processing and packaging. However, there are various restrictions on both the specific functional uses and amounts of paper chemical additives which can be used, so the PDA status should be confirmed by the suppHer before use. 

Chemical manufacturing Production of the API Starting Material Introduction of the API Stalling Material into process Production of Intermediaie(s) Isolation and purification Physical processing, and packaging... 

The section on components deals with all materials that may be used in the manufacture, processing, and packaging of drug products, plus materials used for maintenance of the building and equipment. They must be stored and handled in a safe, sanitary, and orderly manner. These precautions are needed to prevent mix-ups and cross-contamination of drugs and drug products. All items should be held until they have been sampled and tested according to the company s specifications and not released until the tests have been completed. In this section it is required that ... 

Other areas of use of conveyor systems are for transport of rubbers and chemicals to mixers, for carrying product from various sources to further processing and packaging. 

Further extraction Physical processing and packaging Physical processing and packaging... 

Orifice scrubbers are used in industrial applications including food processing and packaging (cereal, flour, rice, salt, sugar) pharmaceutical processing and packaging and the manufacture of chemicals, rubber and plastics, ceramics, and fertilizer. Processes controlled include dryers, cookers,... 

Once the cocaine has been legally produced from the coca leaf, it is exported to various countries for medicinal use, basically as a topical local anesthetic (applied to the surface, not injected, only treating a particular area). In the United States the crystalline powder is imported to pharmaceutical companies who process and package the cocaine for medical use. Merck Pharmaceutical Company and Mallinckrodt Chemical Works distribute cocaine in crystalline form (Hydrochloride Salt) in dark colored glass bottles to pharmacies and hospitals throughout the United States. Cocaine, in the alkaloid form (base drug containing no additives such as hydrochloride in the crystalline form) is rarely used for medicinal purposes. Cocaine hydrochloride crystals or flakes come in Vs, A and 1 ounce bottles from the manufacturer and has a wholesale price of approximately 20 to 25 per ounce (100% pure). 

Cracks, holes, or loose joints in interior walls, floors, and overhead areas must be sealed so that they do not become harborages for insects or rodents. Equipment used for transporting, processing, and packaging food products should also be designed to minimize the buildup and/or accumulation of food materials within the interior of the equipment. 

Sachet very precise dosage convenient storage and usage stricter processing and packaging requirements compared to liquid/gel... 

The DPIs cannot be considered only as devices, but must be considered as components of a larger delivery system, which includes the formulation of the drug powder, its manufacturing processes, and packaging. 

To establish a microbial-limit testing history, all development, clinical, scale-up and process validation batches of new nonsterile dosage forms would be tested to verify that the pharmaceutical ingredients, manufacturing process, and packaging does not contribute to the bioburden of the product. After the testing history has been... 

---