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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