The goal of this chapter is to give a general understanding of pharmaceutical microbiology, its role in the industry, and its impact on the quality of the finished products. Sterility is defined by the total absence of microorganisms. This is a simple concept but difficult to establish in absol...
Understanding of the Terms Validation,Verification and Qualification in Quality Management Objective To correct the confusion terminology use of the current quality management terms validation,verification and qualification in pharmaceutical fiel... D Tan,H Yang,H Zhang - 《Chinese Pharmaceutical Affairs》 ...
protocol is signed. tional information that will be included with the results, Training should be documented. such as example chromatograms and spectra, along with The transferring unit, often the development unit, is re- additional information in case of a deviation. The protocol sponsible for ...
Compliance in pharmaceutical industry mainly refers to GMP compliance, meaning compliance with current legally binding pharmaceutical quality system requirements as outlined in worldwide aligned GMP regulations. What are regulatory compliance requirements? Regulatory compliance requires companies to fulfill all ...
In the International Vocabulary of Metrology (VIM) and documents of the International Organization for Standardization (ISO), “accuracy” has a different meaning. In ISO, accuracy combines the concepts of unbiasedness (termed “trueness”) and precision.] Determination—In the case of the assay of...
Advances in validation, risk and uncertainty assessment of bioanalytical methods 作者:Rozet E*; Marini R D; Ziemons E; Boulanger B; Hubert Ph 来源:Journal of Pharmaceutical and Biomedical Analysis, 2011, 55(4): 848-858. DOI:10.1016/j.jpba.2010.12.018 ...
There were 65 total items in the first round of content validity. The results are summarised in Table2. Face validity was deemed appropriate for all items. For content validity, 61 items were assessed, meaning 4 items were not assessed. Items not assessed were follow-up questions and thus, ...
The concept of pH is very special in the field of physicochemical quantities, because of its widespread use as an important control property and process descriptor and because of the difficulty of defining its theoretical meaning. Despit... Fisicaro Paola,Ferrara Enzo,P. Enrico,... 被引量: 2...
Each document referenced focuses on the particular audience for its associated organization(s), including system developers and suppliers, pharmaceutical industry sponsors, and regulators (Table 1). The context of the definitions provided for V3 vary greatly, highlighting that language and processes are ...
APIC/Revision201904(202102更新)/Guidanceonaspectsofcleaningvalidationinactivepharmaceuticalingredientplants TTC原则是基于口服可接受日摄入水平,但可以扩展至注射途径(即静脉给药,皮下、肌内)。 Furthermore,thethresholdsarebasedonchronicexposure,meaningthatincaseofanatypicaleventincleaningvalidationanadditionalmarginofsafety...