Allen Loyd V, Okeke Claudia C
International Journal of Pharmaceutical Compounding, Edmond, Oklahoma.
Int J Pharm Compd. 2008 Jul-Aug;12(4):344-53.
Beyond-use-dates for sterile preparations are divided into two categories. If a program of sterility testing is not in place, then the short beyond-use dates specified in United States Pharmacopeia Chapter 797 for the different risk levels are to be used. If a program of sterility testing is in place, then the beyond-use dates described in United States Pharmacopeia Chpater 795 for stability of various types of preparations/formulations can be used, which are somewhat longer than those in Chapter 797. Beyond-use dates are established on the basis of chemical and physical aspects of a compounded preparation. If a sterility testing program is in place, then each compounded preparation is considered "sterile" and the areas of concern are chemical and physical stability. In manufacturing, not every dosage unit is tested, only a sample. Similarly, only a sample of compounded preparations is tested. A sterility testing program must be in place to demonstrate that compounding proceures are under control. If a longer beyond-use date is needed, then appropriate and specific stability studies of the compounded preparation must be undertaken. A very generalized difference between Chapter 795 and Chapter 797 is the requirement for sterility. The majority of Chapter 797 is involved with the requirements necessary to achieve and/or maintain sterility in compounded preparations and includes standards for the facility, equipment materials, personnel, and training.
无菌制剂的有效期分为两类。如果没有无菌测试程序，那么就要采用美国药典第797章针对不同风险水平规定的较短有效期。如果有无菌测试程序，那么就可以采用美国药典第795章中所述的各类制剂/配方稳定性的有效期，这些有效期比第797章中的要长一些。有效期是根据复方制剂的化学和物理特性确定的。如果有无菌测试程序，那么每一份复方制剂都被视为“无菌”，关注的方面是化学和物理稳定性。在生产过程中，并非每个剂量单位都进行测试，只测试一个样本。同样，复方制剂也只测试一个样本。必须有一个无菌测试程序来证明配制过程处于受控状态。如果需要更长的有效期，那么必须对复方制剂进行适当且具体的稳定性研究。第795章和第797章一个非常普遍的区别在于对无菌的要求。第797章的大部分内容涉及在复方制剂中实现和/或维持无菌所需的要求，包括设施、设备材料、人员和培训的标准。
