Evaluation And Implementation Of Cleaning Validation In Multi Collinear Production Line

Based on the consideration of rational use of resources,cost saving and optimal management,multi-collinear production was widespread in the pharmaceutical production。Multi-collinear production often involve many kinds of products and equipment,complex production process.GMP has high requirements for risk assessment,qualification and validation of multi-collinear products.Contamination and cross contamination have been pay more attention in multi-collinear workshop.Once cross contamination occurs between different drugs,it may endanger the life safety of patients.Cleaning validation is an important tool to evaluate the applicability and effectiveness of equipment cleaning process.There are GMP items related to cleaning validation in China,but lack of dedicated implementation guidelines,and relevant enterprises lack corresponding guidance in the implementation of cleaning validation.The purpose of this paper is to discuss the evaluation and implementation of cleaning validation for multi-collinear production line.Firstly,this paper described the the current situation of drug multi-collinear production,and emphasized the importance of cleaning validation.The selection of cleaning process,the development of cleaning methods,and how to evaluate and implement cleaning validation of multi-collinear production were described.Then,the worst case was determined by risk assessment,and the maximum allowable residue(MAC)of collinear product exchange sequence was calculated by product matrix by daily therapeutic dose and toxicology data.The minimum MAC in the matrix was selected to calculate the acceptance limit of unit area.Secondly,according to the contact route and product characteristics of different equipment and products,the sampling method and acceptance limit of residual samples were determined.Finally,high performance liquid chromatography(HPLC)was used to detect the specific residues of the worst products,and the applicability,precision,accuracy,linearity and range of HPLC analysis method were studied.Through the example of cleaning validation in sterile injection workshop of K pharmaceuticals company,the evaluation tools and implementation methods of cleaning validation disscussed in this paper are illustrated,which has significant application value for the implementation of cleaning validation in collinear production.