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YES,
QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
NO,
STI EXCEPTIONS AND COMMENTS IN
ON NOTEBOOK). OR
NA
Page 2 of 6
YES,
QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
NO,
STI EXCEPTIONS AND COMMENTS IN
ON NOTEBOOK). OR
NA
testing.)
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YES,
QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
NO,
STI EXCEPTIONS AND COMMENTS IN
ON NOTEBOOK). OR
NA
performed (before the employee is
allowed to perform such tasks). (4)
Other: enter in notebook.
211.25(a) Does each employee receive
1.30 retraining on an SOP (procedures) if
2 critical changes have been made in the
procedure?
1.30 Indicate how on-going, periodic GMP
3 training is accomplished.
211.25 is all training documented in
writing that indicates the date of the
1.30
training, the type of training, and the
4
signature of both the employee and the
trainer?
211.25 Are training records readily
retrievable in a manner that enables
one to determine what training an
1.30
employee has received, which
5
employees have been trained on a
particular procedure, or have attended
a particular training program?
1.30 Are GMP trainers qualified through
6 experience and training?
211.25(a) Are supervisory personnel
instructed to prohibit any employee
who, because of any physical condition
(as determined by medical examination
1.30 or supervisory observation) that may
7 adversely affect the safety or quality of
drug products, from coming into direct
contact with any drug component or
immediate containers for finished
product?
1.30 211.28(d) Are employees required to
8 report to supervisory personnel any
health or physical condition that may
have an adverse effect on drug product
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YES,
QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
NO,
STI EXCEPTIONS AND COMMENTS IN
ON NOTEBOOK). OR
NA
Page 5 of 6
YES,
QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
NO,
STI EXCEPTIONS AND COMMENTS IN
ON NOTEBOOK). OR
NA
7
1.40 Describe how entry is
8 monitored/restricted:
1.40 Is a security person available 24 hours
9 per day?
1.5 Internal Quality/GMP Audit Program
1.50 Does this business unit/facility have a
1 written quality policy?
1.50 Is a copy of this quality policy furnished
2 to all employees?
1.50 If "yes" to above, when provided?
3 __________________
1.50 Is training provided in quality
4 improvement?
1.50 Does a formal auditing function exist in
5 the Quality Assurance department?
Does a written SOP specify who shall
1.50 conduct audits and qualifications
6 (education, training, and experience) for
those who conduct audits?
Does a written SOP specify the scope
1.50
and frequency of audits and how such
7
audits are to be documented?
1.50 Does a written SOP specify the
8 distribution of the audit report?
1.6 Quality Cost Program
1.60 Does this facility have a periodic and
1 formal review of the cost of quality?
Does this facility have the ability,
1.60 through personnel, software, and
2 accounting records, to identify and
capture quality costs?
1.60 Does this facility make a conscious
3 effort to reduce quality costs?
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