Manufacturing of Pharmaceutical Products

Thio-4-oxoselenazolidines substituted in the 3-position, have been described in a number of patents, (79. 80). They are used as intermediates in the manufacture of pharmaceutical products and color sensitizers in photography. They are obtained by action of isothiocyanates on a-hydroselenoacetic acid in the presence of strong base and in the absence of air (Scheme 77). 

At its core, each manufacturer must have a QA system appropriate to the manufacture of pharmaceutical products. Essential elements that such a system should address are summarised in Figure 11.6. 

Compressed air has many applications in the manufacture of pharmaceutical products. 

Following these announcements, the first wave of publications addressing the use of SMB for the manufacture of pharmaceutical products of interest was published. The separation of a chiral hetrazepine [26], WEB 2170 6-(2-chlorophenyl)-8-9-di-hydro-l-methyl-8-[(morpholinyl)-carbonyl]-4H,7H-cyclopenta[4,5]-thieno[3,2-f][l,2,4]triazolo[4,3-a][l,4]diazepine. WEB 2170 is a chiral hetrazepine from Boehringer-Ingelheim. The enantioseparation of WEB 2170 was performed using cellulose triacetate (CTA) from Merck (Darmstadt) as the CSP and with pure methanol as eluent. 

The formulation science used in the manufacture of pharmaceutical products is a complex discipline in its own right, and largely outside of the scope of this chapter only a very brief overview will be presented here. 

Other standards organizations such as the ASTM International who has been active in the area of PAT since late 2003 in the development of standards for the use of PAT in the pharmaceutical industry internationally in their standard committee E55 on Manufacture of Pharmaceutical Products... 

The cGMP regulations for the manufacture of pharmaceutical products are contained in Parts 210 and 211 of Title 21 of the Code of Federal Regulations (CFR) [1]. These regulations, as well as guidance documents and other FDA documents... 

Excipients Council (IPEC) [10] (excipients), and the USP [11] have also published GMP guidelines. These guidelines require manufacture of pharmaceutical products with acceptable microbial bioburden and free of objectionable microorganisms. 

WHO GMP. Good Practices in Manufacturing of Pharmaceutical Products in WHO Expert Committee on Specifications for Pharmaceutical Preparations, 32 edition, Geneva (1992). 

PIC (1992), Guide to Good Manufacturing Practice for Pharmaceutical Products, Convention for the Mutual Recognition of Inspection in Respect of the Manufacture of Pharmaceutical Products (PIC), Document PH 5/92, Pharmaceutical Inspection Convention. 

Japanese Ministry of Health and Welfare (1993), Guideline on Control of Computerised Systems in Drug Manufacturing, Manual for Control of Computerised Systems in GMP, Audit Manual for Manufacturers of Pharmaceutical Product with Computer Systems. 

M Kobayashi. Manufacture of Pharmaceutical Products and Freeze-Drying Technology (Japanese), Vol. 12, Pharmaceutical Products and Machines, Tokyo, 1982. 

These guidehnes aim to give guidance to inspectors of pharmaceutical manufacturing facilities and manufacturers of pharmaceutical products on the requirements for validation. The main part covers the general principles of validation and qualification. In addition to the main part, appendices on validation and qualification (e.g. cleaning, computer and computerized systems, equipment, utilities and systems, and analytical methods) are included. 

In the context of dramatically increasing the access to, and affordability of, HIV/AIDS-related care and treatment, WHO, together with UNICEF, UNAIDS and UNFPA are inviting expressions of interest from manufacturers of pharmaceutical products in respect to the provision of drugs for the management of HIV-related diseases. The World Bank is in support of this effort. 

Please state all the names and addresses at which manufacturing of pharmaceutical products to be prequalified takes place, and indicate in which year the factory was built. Include dates of upgrading and adaptation, as well as a description of the activity ... 

Through sequential examination of production and control activities of the manufacturer, the manufacturer of pharmaceutical products may be included on the prequalification list as a manufacturer of pharmaceutical products for possible supply of specified products to procurement agencies and other agencies. 

To ensure the manufacturing of pharmaceutical products in ABC Pharmaceutical according to international standards, there are several guidelines that are considered for the planning, construction, start-up, and validation of the buildings, equipment, and processes. 

European Free Trade Agreement (1992) Guide to good manufacturing practice for pharmaceutical products, the convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products. Document 5/92 (PIC guidelines on GMP). European Free... 

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