SUN Pharma Halol Baroda Gets three Observations | GMP VIOLATIONS | FDA | 483 |

SUN Pharma Halol Baroda Gets three Observations | GMP VIOLATIONS | FDA | 2018 |

US FDA has inspected India’s major Drug maker M/s SUN pharmaceuticals dated 12-02-2018 to 23-02-2018 and revealed form 483 with 03 observations.

The observations related to Facility design, written procedures, equipment and cleanliness, according to the U.S. Food and Drug Administration’s Form 483 reviewed by GmpViolations.com

Observation 1:

Separate of defined areas to prevent contamination or mix-ups deficient regarding operations related to aseptic processing of drug products

As inspector has stated that aseptic filling lines showed poor design as the

·        Area barriers such as Grade-A and Grade-B has been shown that rough, cracked and uneven surfaces as these rough surfaces may create difficult to clean and leads aseptic area contamination.

·  The ceiling above the filling equipment has channels surrounding each of the HEPA filters that are approximately one wide by three inches deep that cannot be accessed with a mop used during cleaning/sanitizing.  There is extensive use of sealant around all the HEPA filter units and various rough surfaces on the ceiling such as mounting bolts for the filters that create a difficult-to-clean surface in the Grade-A environment.

·   Air-flow visualization studies conducted in April 2017 show upward flow of smoke from below waist level up towards the ceiling return grates of Grade B areas immediately adjacent to Grade A areas. These Grade A areas are used for loading a ___ and filling sterile liquid product vials.

·       The Aseptic behavior of personnel not adequate as personnel constant movement with their gloved hands, during machine setup there is no environmental monitoring in place, the selected sampling locations not justified as required.

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.

·    The equipment’s is not installed and maintained according to a written procedures to reduce risk to product contact surfaces or process materials.  

·  The Inspector has observed that the equipment has labelled as “CLEANED’ however the inspector had found residue on the gasket, torn and degraded style gasket (in adequate PM in place).

·   Most of the equipment shown that degraded and dis-coloured gaskets of storage tanks and there is no written procedure in place for replacement of gasket.

Observation 3:

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

·       The Cleaning and operation of Vial/Ampoule machine allows the performance of 2 sequential failures without initiation of a deviation investigation. The procedure also states, repeat rejection from the operation as false rejection. (The procedure its influence by-pass the deviations and leads the missing of CAPAs for get rid of re-occurrences)
     
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