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Tuesday, March 6, 2018

Aurobindo Pharma As Unit 4 Gets Nine Observations | GMP VIOLATIONS | FDA |
















Aurobindo Pharma As Unit 4 Gets Nine Observations | GMP VIOLATIONS | FDA |

The observations related to equipment and cleanliness, employees training, quality control and computer controls, according to the U.S. Food and Drug Administration’s Form 483 reviewed by GmpViolations.com 

Observation 1:

Aseptic processing areas are deficient regarding system for maintaining any used to control the equipment aseptic conditions?

During inspection the FDA inspector has observed the un-cleaned debris material on the Filling machine and inspector has informed to the respective personnel on the spot, however next day, the same has been observed and filling carried out with dirty equipment (without cleaning).

Observation 2:

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, Quality or Purity of the drug product.
This can be concluded that the operators are failed to follow c-GMP practices or the written procedures as the Equipment or its utensils must clean and must do follow sanitize in early interval. The Inspector has expected the good aseptic practices and ensure the Product SISPQ.

Observation 3:

Equipment used in the manufacture, processing, packing or holding of Drug products is not appropriate design to facilitate operations for its intended use.
The Vial washer Qualification with inspected Vial presentation not adequate, Example Vial washer failed to demonstrate if vail washer is able to remove bioburden from glass vials that are used for filling. Failed to use statistically sound number of vials to demonstrate the effectiveness of the wash cycle and processes.

“The Batch size selected for cleaning process Qualification is not appropriate as the it was 1% of actual batch size.

“The Batch size selected for endotoxin verification is not appropriate as the it was 1% of a commercial lot size.

Observation 4:

Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
During Inspector walk-through of the facility a large mosquito has appeared inside the room, semi-finished product storage area holding. This room is located inside the unclassified but controlled environment corridor and is connected sets of doors. This room is two sets of doors away from the grade-B and grade “A” areas where the filling and activities for injection takes place.

Observation 5:

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Here it was concluded that failed to demonstrate the efficacy of the cleaning process, which is part of your cleaning activities, to eliminate contaminants in the hard to reach area in the aseptic fill and areas (grade A &B)

Observation 6:

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Observation 7:

The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.

The procedure for receiving and inspection of the components and packaging materials, (sampling of pacing materials) follows an unspecified level of AQL of with no clear criteria for acceptance and rejection level. This procedure is deficient to provide clear reject and acceptance levels.

Observation 8:

Established laboratory control mechanisms are not followed and documented at the time of performance.

Laboratory control is deficient in that____ USP reference standards, code # with lot #.. used to determine the identity, strength, quality and purity of drug injection which were received in laboratory.

And were not received in laboratory inventory management system (LIMS) as required by your procedure, however they were stored in the same container as other standards which were previously received and were in use.

Were not placed in desiccator as it is recommended on the COA.

Observation 9:

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel.


Master batch records that are submitted in #___ for __ injection, have different batch codes (document number) than the batch records that are currently in use for commercial production and master batch records that are submitted. 

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