● Wockhardt’s warning letter details are now disclosed. Overall, the
FDA has cited six observations and even suggested Wockhardt
hire a third-party auditor with experience in detecting data integrity
problems. It is unusual for the FDA to suggest hiring a CGMP
expert and data integrity consultant in a warning letter.
● The FDA has cited several instances where the investigators were
not given complete information or late information. The FDA has
questioned Wockhardt’s practice of performing undocumented
trial runs and noted instances where content of unofficial batch
records and official batch records did not match.
● The investigators found that some of the instruments had the audit
trail functions disabled and noted that “The lack of reliability and
accuracy of data generated by your firm’s laboratory is a serious
CGMP deficiency that raises concerns with all data generated by
your firm”…“These findings include repeat citations from the
January 2012 inspection…”.
● Wockhardt has earlier mentioned that import alert on Waluj facility
impacts sales by $100 mn and half of the pending applications.
Inspection of second US facility is scheduled in July-13 or Aug-13.
FDA released Wockhardt’s warning letter details
We provide key takeaways from FDA’s warning letter on Wockhardt’s
Waluj facility. Overall, the FDA has cited six observations and even
suggested Wockhardt hire a third-party auditor with experience in
detecting data integrity problems. It is unusual for the FDA to suggest
the hiring of a CGMP expert and data integrity consultant.
The FDA has mentioned that the data integrity consultant should
“Identify any historical period(s) during which inaccurate data occurred
at your facilities”….”Use organisational charts and SOPs to identify
the specific managers in place when the inaccurate data reporting
was occurring and determine the extent of top and middle
management involvement in or awareness of data manipulation”.
Observation #1: “Wockhardt repeatedly delayed, denied, limited
an inspection or refused to permit the FDA inspection”
The FDA has cited several instances in the warning letter where the
FDA investigator was not given complete information or the
information provided was late which impacted the inspection. In one of
the instances FDA mentions that “The Production Head
acknowledged that he had provided inaccurate information in the
previous instances”.
Observation #2: “Wockhardt failed to prepare batch production
and control records for each batch of drug product that include
documentation of the accomplishment of each significant step in
the manufacture, processing, packing, or holding of the batch”
The FDA investigators found unofficial batch records torn in half in a
waste area. These records contained data indicating that some
batches failed to meet the in-process visual inspection specifications
while the official batch records for these batches state that these
batches had met the specifications. The FDA further states that
“Wockhardt’s affidavit confirms that your firm uses unofficial visual
inspection to remove the defective units from the production line
without appropriate documentation and investigation”. “This raises
serious concerns regarding the integrity, reliability and accuracy of the
data generated and available at your facility”.
Observation #3: “Wockhardt failed to ensure that laboratory
records included complete data derived from all tests necessary
to assure compliance with established specifications and
standards”
The FDA investigators identified the practice of performing trial
sample analysis prior to collecting the official analytical data. These
trial runs were not recorded in the equipment use log, and sample
preparation data associated with these analyses was destroyed,
preventing any calculation or analysis of the resulting data. The FDA
has questioned this practice “…unacceptable practice of performing
undocumented “trial” runs at your facility…”.
Observation #4: “Wockhardt failed to record and justify any
deviations from required laboratory control mechanisms”
FDA investigators found that some of the instruments had the audit
trail functions disabled and noted that “there is no assurance that the
data generated using these instruments is accurate”. The FDA further
noted that “The lack of reliability and accuracy of data generated by
your firm’s laboratory is a serious CGMP deficiency that raises
concerns with all data generated by your firm….These findings include
repeat citations from the January 2012 inspection and indicate that
your quality control unit is not exercising its responsibilities and may
not have the appropriate authority or ability to carry out its
responsibilities…”
Observation #5: “Wockhardt failed to ensure that each person
engaged in the manufacture, processing, packing, or holding of a
drug product has the education, training, and/or experience, to
enable that person to perform the assigned functions”
The FDA authorities found a few incomplete training questionnaire
records where the trainee and trainer names were left blank on the
questionnaires, but were pre-filled with the answers.
Observation #6: “Wockhardt failed to provide adequate washing
and toilet facilities to working areas”
“..We are concerned that your firm has been cited for inadequate
cleaning and sanitary conditions during previous inspections, and that
your responses to these citations promised corrective actions;
however, our inspections continue to reveal problems in this area of
CGMP”.
��
FDA has cited six observations and even suggested Wockhardt
hire a third-party auditor with experience in detecting data integrity
problems. It is unusual for the FDA to suggest hiring a CGMP
expert and data integrity consultant in a warning letter.
● The FDA has cited several instances where the investigators were
not given complete information or late information. The FDA has
questioned Wockhardt’s practice of performing undocumented
trial runs and noted instances where content of unofficial batch
records and official batch records did not match.
● The investigators found that some of the instruments had the audit
trail functions disabled and noted that “The lack of reliability and
accuracy of data generated by your firm’s laboratory is a serious
CGMP deficiency that raises concerns with all data generated by
your firm”…“These findings include repeat citations from the
January 2012 inspection…”.
● Wockhardt has earlier mentioned that import alert on Waluj facility
impacts sales by $100 mn and half of the pending applications.
Inspection of second US facility is scheduled in July-13 or Aug-13.
FDA released Wockhardt’s warning letter details
We provide key takeaways from FDA’s warning letter on Wockhardt’s
Waluj facility. Overall, the FDA has cited six observations and even
suggested Wockhardt hire a third-party auditor with experience in
detecting data integrity problems. It is unusual for the FDA to suggest
the hiring of a CGMP expert and data integrity consultant.
The FDA has mentioned that the data integrity consultant should
“Identify any historical period(s) during which inaccurate data occurred
at your facilities”….”Use organisational charts and SOPs to identify
the specific managers in place when the inaccurate data reporting
was occurring and determine the extent of top and middle
management involvement in or awareness of data manipulation”.
Observation #1: “Wockhardt repeatedly delayed, denied, limited
an inspection or refused to permit the FDA inspection”
The FDA has cited several instances in the warning letter where the
FDA investigator was not given complete information or the
information provided was late which impacted the inspection. In one of
the instances FDA mentions that “The Production Head
acknowledged that he had provided inaccurate information in the
previous instances”.
Observation #2: “Wockhardt failed to prepare batch production
and control records for each batch of drug product that include
documentation of the accomplishment of each significant step in
the manufacture, processing, packing, or holding of the batch”
The FDA investigators found unofficial batch records torn in half in a
waste area. These records contained data indicating that some
batches failed to meet the in-process visual inspection specifications
while the official batch records for these batches state that these
batches had met the specifications. The FDA further states that
“Wockhardt’s affidavit confirms that your firm uses unofficial visual
inspection to remove the defective units from the production line
without appropriate documentation and investigation”. “This raises
serious concerns regarding the integrity, reliability and accuracy of the
data generated and available at your facility”.
Observation #3: “Wockhardt failed to ensure that laboratory
records included complete data derived from all tests necessary
to assure compliance with established specifications and
standards”
The FDA investigators identified the practice of performing trial
sample analysis prior to collecting the official analytical data. These
trial runs were not recorded in the equipment use log, and sample
preparation data associated with these analyses was destroyed,
preventing any calculation or analysis of the resulting data. The FDA
has questioned this practice “…unacceptable practice of performing
undocumented “trial” runs at your facility…”.
Observation #4: “Wockhardt failed to record and justify any
deviations from required laboratory control mechanisms”
FDA investigators found that some of the instruments had the audit
trail functions disabled and noted that “there is no assurance that the
data generated using these instruments is accurate”. The FDA further
noted that “The lack of reliability and accuracy of data generated by
your firm’s laboratory is a serious CGMP deficiency that raises
concerns with all data generated by your firm….These findings include
repeat citations from the January 2012 inspection and indicate that
your quality control unit is not exercising its responsibilities and may
not have the appropriate authority or ability to carry out its
responsibilities…”
Observation #5: “Wockhardt failed to ensure that each person
engaged in the manufacture, processing, packing, or holding of a
drug product has the education, training, and/or experience, to
enable that person to perform the assigned functions”
The FDA authorities found a few incomplete training questionnaire
records where the trainee and trainer names were left blank on the
questionnaires, but were pre-filled with the answers.
Observation #6: “Wockhardt failed to provide adequate washing
and toilet facilities to working areas”
“..We are concerned that your firm has been cited for inadequate
cleaning and sanitary conditions during previous inspections, and that
your responses to these citations promised corrective actions;
however, our inspections continue to reveal problems in this area of
CGMP”.
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