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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prevent unintended use of superseded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.