Regulatory Issues

In the Validation Documentation Inspection Guide, US Department of Health and Human Services, Food and Drug Administration, 1993, process validation is defined as follows:

• Establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

• The Guide to Inspections of Lyophilization of Par-enterals, published by the US Food and Drug Administration, July 1993, contains among others the chapters 'Lyophilization Cycle and Controls', 'Cycle Validation' and 'Lyophilizer Sterilization/Design'.

Figure 12 Schema of a laboratory freeze-drying plant: 1, two-stage vacuum pump; 2, exhaust filter; 3, valve; 4, refrigeration compressor; 5, liquefaction of refrigerant; 6, valve; 7, filter; 8, injection valve; 9, drain valve; 10, ice condenser; 11, pressure switch; 12, ventilator; 13, drying chamber with heated shelves and closing system for stopper of vials. (Lyovac® GT 2, Courtesy of Steris GmbH, Hurth, Germany.)

Figure 12 Schema of a laboratory freeze-drying plant: 1, two-stage vacuum pump; 2, exhaust filter; 3, valve; 4, refrigeration compressor; 5, liquefaction of refrigerant; 6, valve; 7, filter; 8, injection valve; 9, drain valve; 10, ice condenser; 11, pressure switch; 12, ventilator; 13, drying chamber with heated shelves and closing system for stopper of vials. (Lyovac® GT 2, Courtesy of Steris GmbH, Hurth, Germany.)

In the European Union, the directive 91/356 EEC provides the principles and guidelines of Good Manufacturing Practice (GMP). In a series of annexes, supplementary guidelines are covered, but up until 1996 only 'Annex 1: Manufacture of Sterile Medical Products' has been revised. In spite of all these guidelines and annexes, Monger summarized the situation for the user of freeze-drying processes and installations as follows: 'It might be expected that some substantial guidance would be provided. Regrettably, this is not so'.

Powell-Evans provided a range of advice on how to 'streamline validation', which he calls 'one of the most time-consuming and costly exercises faced by pharmaceutical manufacturers'. The qualification and validation of freeze-drying installations and processes for the production of pharmaceuticals cannot be summed up in this section. For cosmetic and food products regulatory issues, depending on the country of manufacturing and use, have also to be followed.

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Solar Panel Basics

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