Formulation And Implementation For Plan Of Examine New Product Children Calcium Carbonate Granule D₃ Process Validation

Pediatric Calcium Carbonate D₃ granules is a western medicine in OTC type-B,and a calcium supplement for children,which can promote growth and bone calcification,improve dental sound.According to GMP requirements,the process of new products of children calcium Carbonate D₃ granules was validated by Yanbian University Herbage Pharmaceutical Co.,Ltd.The examination for the GMP of Pharmaceutical enterprise uses scientific and effective method for designing verification plan.The research contents of this subject include the preparation and implementation of pediatric calcium Carbonate D₃ granules and cleaning process.According to the production prescription,production process,production equipment and quality standards,we determined sampling equipment and sampling site.The risk of the whole process was evaluated by the Fishbone Diagram and FMEA method.Production process including pre mixing,granulation drying,whole grains,total mixing,etc were validated.Before the cleaning process verification scheme is formulated,the methods of inspection and sampling are validated.The accuracy,special property,LOD,LOQ and durability of atomic absorption spectrometry are verified.The accuracy of swab wiping sampling method was investigated by recovery rate.According to the nature of the cleaning process residues,the material and the acceptable standards of the equipment,the hardest cleaning substances,the hardest cleaning sites and the sampling sites were determined.The risk of the whole process was evaluated by the Fishbone Diagram and FMEA method before a clean process verification scheme was formulated.Three consecutive batches of 960801,960802 and 960803 were tested according to the verification scheme.The results showed that the content,granularity,weightlessness,dissolution and microbial limit of three batches were in conformity with the standard.At the same time,the residue limits of active ingredients and microbial limits after cleaning are in conformity with the standard.The process verification scheme is safe,stable and effective,and complies with GMP requirements.The preparation and implementation of the process verification scheme for Pediatric Calcium Carbonate D₃ granules,which has certain theoretical and practical significance to improve the internal GMP system,optimize the craft,improve the production efficiency,prevent pollution or cross-contamination,reduce the risk of product and guarantee the safety of medication.