Sun Pharma: Halol Plant Unlikely to see Recovery in FY19E; Reduce |

Sun pharma received three observations post USFDA visit of the Halol plant in February 2018. The three observations are neither linked to data integrity nor are linked to any repeat observations. The brief of those observations are:

Observation 1: Separate or defined areas to prevent contamination or mix ups are deficient regarding operations related to aseptic processing of drugs

Observation 2: Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance

Observation 3: Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of drug product containers and closures

We find that observations 2 and 3 are relatively easier to address within 15 days from the completion of the FDA visit as those do not require any data-generation activities. Observation 2 is related to establishment of written procedure for assembling and reassembling of machine parts, while observation 3 is related to written procedure of sampling, testing, approval and rejection of products in QC activities


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