TOPIC:- GOOD DOCUMENTATION PRACTICES

 

Good Documentation Practice:

It is an important part of Good Manufacturing Practice which specifies the standard of document completion should meet the minimum requirements based on regulatory guidelines, requirements and expectations. It is the responsibility of all employees to follow Good Documentation Practice.

 

 

Principles of Good Documentation Practice:

–A document bearing original signatures should never be destroyed.

–Never falsify information.

–Never use a White-out and cover-over-tapes.

–Never obliterate information or record.

–Never over-write a record.

–Never use pencil – all information should be completed in permanent Blue ink.

–No spaces, lines or fields are to be left blank.

–Never use symbols e.g. ditto marks or arrows to indicate repetitive and consecutive.

 

Different Types of Documents and Records:

–BMR /BPR , BOMs, Specifications, SOP, Protocols, Policies, Test Methods, Forms/Log sheets, Quality records , CoA, Technical transfer reports, Validation documentation, Training Assessments.

General Requirements for Good Documentation Practices:

1. All documents must be clear, accurate and written in a manner that prevents errors and ensures consistency.

2. All records must be filled out in indelible blue ink ball point pen for long term Do not use pencil or ink that can be erased.

3. Documents and records should be reviewed by someone who did not perform the task to ensure that the information is correct and accurate.

4. Handwritten signatures must be unique to the individual and listed within the site signature specimen list

5. GMP records are accurate and any changes or amendments are made in a compliant manner.

6. Deliberately amending or destroying GMP records to hide or falsify data is fraud.

7. Do not discard a GMP record just because you might have made a mistake, it is still required for traceability.

8. It is not acceptable to discard GMP records for any reason unless the retention period expiry is reached.

9. Loose unofficial papers, notes and uncontrolled documents that can easily be lost or changed without appropriate approval do not meet GDP requirements.

10. Do not use notebooks/legal pads with easily removed pages, scrap paper or post-it-notes to record GMP information.

11. blank spaces, rows, columns must be marked out NA with a single line across the whole field or

12. Back dating of entries is not permitted

 

13. Making legible correction–Make a single line through the error Record the correction close by with sign and Date of correction. Numbering corrections is acceptable when space is limited. If the record becomes too congested with corrections, an attachment may be used, however the original record must indicate the number of pages attached and the attachment reference the record it is related to.

14. Date Format:

DD/MM/YY e.g.: 01/01/24

15. Time Format:

HH:MM (24 Hrs) e.g.: 13:17

What is ALCOA?

 

It gives idea about how data should be recorded, handled, and retained to comply with regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, and ICH Q7/Q9/Q10.

 

ALCOA is an acronym that stands for:

1. Attributable

2. Legible

3. Contemporaneous

4. Original

5. Accurate

Detailed Explanation of ALCOA Principles

Attributable :-	Every data entry should clearly show who performed the action and when. This includes time stamps and user identification (e.g., a login ID or signature).
Legible :-	All data must be readable and understandable. If handwritten, it must be clear; if electronic, it must be in a format that is accessible and preserved for the required retention period.
Contemporaneous:-	Data must be recorded at the time the activity is performed, not afterward. This ensures accuracy and traceability.
Original :-	The record should be the first capture of the data (e.g., a signed form, electronic log, or validated electronic record). If copies are used, they must be verified as true copies.
Accurate :-	Data should be free from errors, with proper corrections made transparently. Any modification must be documented without obscuring the original entry.

 

What is ALCOA++?

ALCOA++ builds on ALCOA by including additional principles that further enhance data quality and compliance. The “++” elements focus more on data integrity culture and the management system around data.

Complete:-

All data must be entire, meaning nothing relevant has been deleted, omitted, or hidden. Includes metadata, audit trails, and all associated records.

Consistent:-

Data entries should be in a logical sequence and follow procedures, using consistent formats, timestamps, and standards.

Enduring:-

Records must be preserved in a durable format for the required retention period. Fragile formats (e.g., post-it notes) are not acceptable.

Available:-

Data must be accessible for review and inspection throughout its lifecycle. It should be retrievable when needed, even years after creation.

 

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