英国药典有做可见异物检查法这项内容么? 我找到的都是不溶性微粒检查法, 还有,有谁知道关于国外注射剂通则检查有哪些项目?例如:英国药典和美国药典...
英国药典可见微粒的的项目，有检查方法，但没有提供放行标准（The test for visible particles included as Appendix XIII B is method text 2.9.20 of the European Pharmacopoeia. This text describes standardised viewing conditions but sets no criteria of acceptance.），但是只要仔细研究，你就会发现BP在注射剂总则中对于visible Particles的规定，总论中有下列的话：clear and practically free from particles。但practically 是个非常模糊的词语，实践中容易产生纠纷（can give rise to problems of interpretation）， 国外采用什么方式解决呢？一般采用第三方仲裁的方法，比方说让医院药房控制质量的药剂师按照药典的规定的方法检验，来判断是否存在可见微粒超标的问题。（These problems could, perhaps, be overcome by providing simple criteria for the test for visible particles suitable for application as a pharmacopoeial 'check-test', that is, for application by an independent analyst, for example, a hospital quality control pharmacist, as a means of judging the quality of a particular parenteral preparation）。具体的检验操作方法和中国的灯检法差不多，抽检20瓶，假如有可见微粒的瓶数超过1瓶，那么就判定为不合格。 For guidance, it is suggested that in total 20 containers are examined as described in Appendix XIII B and any particles recorded. It is suggested that the preparation being examined should be considered to have failed the test if one or more particles are found in more than one container.
然后我们分析，为什么BP不象CP那样对于可见微粒项目作为放行项目呢？那是因为国外可以通过GMP保证这个项目100%的通过。（打个比方：就象你在欧洲很少发现请勿随地吐痰的标语是一样的道理）It is emphasised that these criteria are not intended for use by a manufacturer for batch release purposes. It is expected that a manufacturer would obtain assurance of the quality of his product with respect to visible particulate matter by 100% inspection or by other appropriate means in accordance with good pharmaceutical manufacturing practice (GMP). 。可见微粒检出率的随机性是非常强的，靠QC检查不靠QA保证这种思维对于药品的质量是一个大隐患（An attributes-based test using a small sample together with simple pass/fail criteria would be consistent with the needs and constraints of a check test. The criteria chosen would need to be capable of detecting a batch that was grossly contaminated while representing an acceptably low chance of condemning batches of satisfactory quality through a small sample being unrepresentative.）如果出现的概率很低，有必要检查这个项目吗？（The need to set limits is based on the premise that an expectation of total absence of visible particles from all containers from a batch of an injectable preparation is unreasonable and unrealistic. ）因此关键就是靠GMP来保证产品的质量，而不是靠QC的检查。想想看，在欧洲你的药品在医院的使用过程中，这个项目不合格被医院的药剂师按质量问题上报当局，那么当地的FDA就来你们工厂调查了 It would, of course, be unlikely that, if a sample failed such a test, consequent action would be initiated by the competent authority on the result of a single test. In such circumstances the competent authority would investigate the occurrence further with the manufacturer
英国药典可见微粒的的项目，有检查方法，但没有提供放行标准（The test for visible particles included as Appendix XIII B is method text 2.9.20 of the European Pharmacopoeia. This text describes standardised viewing conditions but sets no criteria of acceptance.），但是只要仔细研究，你就会发现BP在注射剂总则中对于visible Particles的规定，总论中有下列的话：clear and practically free from particles。但practically 是个非常模糊的词语，实践中容易产生纠纷（can give rise to problems of interpretation）， 国外采用什么方式解决呢？一般采用第三方仲裁的方法，比方说让医院药房控制质量的药剂师按照药典的规定的方法检验，来判断是否存在可见微粒超标的问题。（These problems could, perhaps, be overcome by providing simple criteria for the test for visible particles suitable for application as a pharmacopoeial 'check-test', that is, for application by an independent analyst, for example, a hospital quality control pharmacist, as a means of judging the quality of a particular parenteral preparation）。具体的检验操作方法和中国的灯检法差不多，抽检20瓶，假如有可见微粒的瓶数超过1瓶，那么就判定为不合格。 For guidance, it is suggested that in total 20 containers are examined as described in Appendix XIII B and any particles recorded. It is suggested that the preparation being examined should be considered to have failed the test if one or more particles are found in more than one container.
然后我们分析，为什么BP不象CP那样对于可见微粒项目作为放行项目呢？那是因为国外可以通过GMP保证这个项目100%的通过。（打个比方：就象你在欧洲很少发现请勿随地吐痰的标语是一样的道理）It is emphasised that these criteria are not intended for use by a manufacturer for batch release purposes. It is expected that a manufacturer would obtain assurance of the quality of his product with respect to visible particulate matter by 100% inspection or by other appropriate means in accordance with good pharmaceutical manufacturing practice (GMP). 。可见微粒检出率的随机性是非常强的，靠QC检查不靠QA保证这种思维对于药品的质量是一个大隐患（An attributes-based test using a small sample together with simple pass/fail criteria would be consistent with the needs and constraints of a check test. The criteria chosen would need to be capable of detecting a batch that was grossly contaminated while representing an acceptably low chance of condemning batches of satisfactory quality through a small sample being unrepresentative.）如果出现的概率很低，有必要检查这个项目吗？（The need to set limits is based on the premise that an expectation of total absence of visible particles from all containers from a batch of an injectable preparation is unreasonable and unrealistic. ）因此关键就是靠GMP来保证产品的质量，而不是靠QC的检查。想想看，在欧洲你的药品在医院的使用过程中，这个项目不合格被医院的药剂师按质量问题上报当局，那么当地的FDA就来你们工厂调查了 It would, of course, be unlikely that, if a sample failed such a test, consequent action would be initiated by the competent authority on the result of a single test. In such circumstances the competent authority would investigate the occurrence further with the manufacturer