Case Study Application of SORS (RapID) to In-Container Testing of Raw Materials for PIC/S GMP Annex 8 This is a translated excerpt of an original article published in Pharm Tech Japan1 in 2015. The original article was written by authors at Astellas Pharma Tech Co., Ltd., Japan. Since Japan joined PIC/S in July 20142, Astellas Pharma Tech Co., Ltd. has investigated how to guarantee effective identification of packaged raw materials, as stipulated in EU GMP Annex 8. In a 2013 publication3, the company presented the results from real-world tests using a fixed Raman spectrometer (Raman RXN2 1000) and a portable Raman spectrometer (TruScan RM). Following this, further investigations were carried out into PIC/S GMP Annex 8 compliance using a spatially offset Raman spectrometer (RapID). The results, summarised here, showed that the instrument was capable of detecting materials inside both a paper sack and a nontransparent polyvinyl sack – something that the existing Raman spectrometers failed to do. This makes it possible to complete acceptance testing at the same time as economising on manpower. It also reduces the risk of foreign material or microbial contamination at the point of sampling to zero. Comparing RapID with Current Raw Materials Acceptance Schemes There are two types of sample, obtained from raw materials, that are tested before release to manufacturing. One is a sample intended for testing various quality attributes, e.g., purity, collected from a number of packages using a statistical selection method; the intention being to assess the overall quality of the whole lot. The other is a sample individually taken from every container, with the purpose of guaranteeing identity (through testing) as stipulated by Annex 8. Using the original testing scheme, the overall process is complicated and resource intensive: unopened packages are sent from the warehouse, brought into the sampling room, opened, sampled, resealed and then returned to the warehouse. The greatest benefit in using RapID is that it becomes unnecessary to open the packages to collect samples, and tests can be carried out on site, in the warehouse. For packages that are only tested for identification purposes, it is possible to take an approach where invasive sampling is not carried out. This would improve the workflow, eliminate the need to transport heavy goods, and reduce the risk of microbial and foreign material contamination to zero.

Evaluation of Production Cost-Reductions At Astellas Pharma Tech Co. Ltd, Japan, we decided to compare a real-world application of the new and old testing schemes based on the Annex 8 approach1. As it is one of our main production materials, used in the majority of our factories, we chose lactose monohydrate and calculated the production costs of acceptance testing using the Japanese Pharmacopeia testing methods (IR absorption spectrometry, potassium bromide disk method, known hereafter as the IR method) and then compared it with the production costs of implementing the RapID test. Packages intended...