presentation 2 (documentation))
TRANSCRIPT
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No JudgmentWithoutDocument
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Principle
Good documentation is an essential part of the
quality system.
Clearly written documentation prevents errors
from spoken communication and permits
tracing of batch history.
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Principle
Specifications, instructions, procedures, and
records must be free from errors and available
in writing.
The legibility of documents is of paramount
importance.
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Principle
SpecificationsSpecifications describe in detail the
requirements used during analysis.
ProceduresProcedures give directions for performing
certain operations e.g. cleaning, clothing,
environmental control, sampling, testing,equipment operation...etc
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Principle
Documents should be approved, signed and
dated by appropriate and authorized persons.
Documents should have unambiguous
contents; title, nature and purpose should be
clearly stated.
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Principle
Documents should be regularly reviewed and
kept up-to-date.
The revised, systems should be operated to
prevent unintended use of superseded
documents.
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Principle
Any alteration made to the entry on a
document should be signed and dated.
The alteration should allow the reading of the
original information.
The reason for the alteration should berecorded
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Principle Data may be recorded by electronic systems,
photographic or other reliable means .
Detailed procedures relating to the system in
use should be available and the accuracy of the
records should be checked.
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Principle Only authorized persons should be able to
enter or modify data in the computer and
there should be a record of changes and
deletions.
Access should be restricted by passwords andthe result of entry of critical data should be
independently checked.
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Principle Records electronically stored should be
protected by back-up transfer on magnetic
tape, microfilm, paper or other means.
Data should be readily available throughout
the period of retention.
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Documents required
There should be written procedures for
sampling, which include the person(s)
authorized to take samples, the methods and
equipment to be used, the amounts to be
taken and any precautions to avoidcontamination of the sample .
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Documents required
There should be appropriately authorized and
dated specifications for sample ( e.g.
designated name and the internal code
reference if any, type of sample ,storage
conditions ,special precautions, etc
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Documents required
There should be written procedures and the
associated records for:
Validation.
Equipment operation , calibration,
maintenance, cleaning and sanitation. Personnel training, clothing and hygiene.
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Documents required
Environmental monitoring.
Pest control.
Complaints.
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Documents required
Log books should be kept for equipment
recording, validations, calibrations,
maintenance, cleaning or repair operations,
including the dates and identity of people who
carried these operations out. Record should be in a sequential order.