2.0 | 6124 LAB - Documentation

Good Documentation Practice (GDocP)

- set of principles

- assuring the accuracy, completeness, consistency and reliability

- of the records and data throughout the entire data life cycle

Good Documentation Practice: Compliance

- mandatory

- part of a drug manufacturer's rules and regulations

- strictly enforced and applies to all personnel

Data Integrity

completeness, consistency, and accuracy of data

Data Integrity: Importance

- all data are recorded

- truthfully represents all actions and unit operations in all stages of drug manufacturing and packaging

Data Integrity must be applied to all forms of data (4)

1. Electronically-recorded

2. Paper-based

3. Hybrid

4. Others

Electronically-recorded

using an equipment and other computerized systems

Paper-based

manually on paper (either a lab result or activity)

Hybrid

both paper-based and electronic records constitute the original data

Other Forms of Data

photographs, chromatography plates, images, etc.

Principle of Data Integrity

ALCOA:

Attributable

Legible

Contemporaneous

Original

Accurate

+:

Complete

Consistent

Enduring

Available

Attributable

a data can be attributed to a specific person who:

1. Performed a specific action/unit operation

2. Filled-out a specific paper document

3. Witnessed/attested that a particular action was performed

Attribution of action can be done by (3)

1. Initials

2. Full handwritten signatures (with date and/or time, when applicable/required)

3. Personal seal when required

Attributable: Risks (2)

1. Document forgery

2. Unauthorized Use of Personal Seal

Document forgery: Control measures (2)

1. Use of official and regularly updated initials and signature log

2. Documentation quality control gate

Unauthorized Use of Personal Seal: Control measure

Storage of personal seals in lock-and-key cabinets

Legible

- clear, deciphered easily

- readable by both the writer and the reader

Under LEGIBLE, the data should also be (2)

1. Traceable

2. Permanent

Traceable (5)

✘ correction fluid/tape

✘ data superimposition

✘ forced rubber erasing of pen marks

✘ scotch tape method

✘ write-overs

Permanent (3)

✓ permanent, indelible ink

✘ use of pencil

✘ erasable pens

Under LEGIBLE is the Rules for

Proper Data Correction

Proper Data Correction

1. Strikethrough

2. Correction next to error & asterisk and number

3. Explanation

4. Signature & date

(LCEID or CLIDE)

Legible: Risks (3)

1. Illegal use of erasable pens/pencil

2. Overlooked illegible handwriting/improper correction of entries

3. Missing pen caps

Legible: Special Risk

Missing pen caps

Illegal use of erasable pens/pencil: Control measures (2)

1. GMP audit/inspection of illegal writing materials; confiscation, violation letters/memos

2. Quality Control gate (document control)

Overlooked illegible handwriting/improper correction of entries: Control measure

Quality Control gate (document control)

Missing pen caps: Control measure

Avoid using pens with caps to avoid inadvertent contamination in manufacturing area

Contemporaneous

- performing an action and documentation (when at all cost possible)

- An undocumented action is an action that did not happen

Data recording

- only directly in official controlled documents (manufacturing batch records, equipment usage logbooks, laboratory logbooks)

- date & time of action

Documentation: Prohibited Dating (2)

1. Back-dating (ante-dating)

2. Forward-dating (advance dating)

Back-dating (ante-dating)

recording today

done in the past

Forward-dating (advance dating)

recording (today)

did not happen yet

Contemporaneous: Risks (3)

1. Recording of data on the palms/other parts of the body

2. Recording of data on scratch papers

3. Recording of past data in the present

Recording of data on the palms/other parts of the body: Control measures (2)

1. Random inspection

2. Violation letters/memos

Recording of data on scratch papers: Control measures (3)

1. Random inspection

2. Violation letters/memos

3. Confiscation of blank papers, scratch papers

Recording of past data in the present: Control measure

Use of chronologically-paged logbooks, serialized forms

Original

- First version, created directly and not a copy/imitation

- maintained in official forms/records/logbooks

maintained in official forms/records/logbooks

- available for review—missing original data raises questions

- Control should be in place to review original data—always ask: is the verbal information I have supported by an original data?

- Certified true copies of an original data must be maintained if necessary/required—legacy printouts of some laboratory data may fade over time

Original data is also a data captured/documented _

Original data is also a data captured/documented CONTEMPORANEOUSLY

Original: Risk

Loss of original data due to ink smudging

Loss of original data due to ink smudging: Control measure

Use of prescribed pens (non-smudging ink)

Accurate

- Correct; representing a true value/data

- correct, truthful, complete, valid, and reliable

Accurate: Origin

Latin accurare - "done with care"

_ must be taken before recording any data to ensure that it truthfully represents an action or a result.

Utmost care must be taken before recording any data to ensure that it truthfully represents an action or a result.

True or False: A document with excessive correction ultimately raises questions about the product's quality.

True.

Accurate: Risk

Incorrect data capture/recording

Incorrect data capture/recording: Control measure (3)

1. Second independent checker

2. Ensure current calibration status of gauges

3. Reprimand letters/violation memos for personnel committing excessive erasures on document

second independent checker: Examples (3)

1. quality control

2. supervisor

3. unit manager

ensure current calibration status of gauges: Examples (3)

1. oven temperature

2. pressure gauge

3. speed gauge

Additional Principles (4)

1. Complete

2. Consistent

3. Enduring

4. Available

Complete

- explicitly recorded

✘ brackets

✘ braces

✘ ditto marks

✓ N/A

N/A

1: N/A

> 2: diagonal line (from upper right to lower left) then N/A

multiple: Z marking

Consistent

presented, recorded, dated, in defined sequence (date/time stamps)

Enduring

Data and records must be sustained throughout their retention period

Available

must be available anytime it is requested to be reviewed during inspection/regulatory audit

Common Data Entry Errors in Batch Records (6)

1) Typographical Errors

2) Transposition Errors

3) Omission Errors

4) Incomplete Errors

5) Incorrect Units of Measure

6) Incorrect Dates

Typographical Errors

mistake in transcribing numbers, data, or text

Transposition Errors

swapping the order of numbers

Omission Errors

Failing to record all required information

Incomplete Erors

Leaving fields blank or partially filled

Incorrect Units of Measure

wrong units for measurement

Incorrect Dates

Entering dates in the wrong format or with incorrect values