SOP Title: Good Documentation Practice

SOP Title: Good Documentation Practice

Objective:

To provide comprehensive training in accordance with the requirements of Good Documentation Practice, a pre-requisite to the process of product release in the market place. This document is to ensure that all actions are documented correctly and in a standardised approach.

Scope:

This document describes the requirements for Good Documentation Practice as required by regulatory rules and guidelines. The approach is applicable to all type of documents.

Responsibility:

QA Department: To prepare and approve the SOP. To follow the Procedure for Good Documentation Practices as per this SOP.

Other Departments: To review and follow the Procedure for Good Documentation Practices as per this SOP.

Accountability:

Head – Quality Assurance

Procedure:

Good Documentation Practice: 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.
Procedure:

5.2.1

Principles of Good Documentation Practice:

5.2.1.1

A document bearing original signatures should never be destroyed.

5.2.1.2

Never falsify information.

5.2.1.3

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

5.2.1.4

Never obliterate information or record.

5.2.1.5

Never over-write a record.

5.2.1.6

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

5.2.1.7

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

5.2.1.8

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

5.2.2

Different Types of Documents and Records:

Documentation and records used throughout the manufacturing process, as well as supporting processes (e.g. Quality Control or Quality Assurance), must meet the basic requirements of GDP. These include (but are not limited to):

· Batch Record Forms ( BMR and BPR)

· Bills of Materials (BOMs)

· Specifications

· Policies

· Protocols

· Standard Operating Procedures (SOPs)

· Work Instructions (WIs)

· Test Methods

· Checklists

· Forms/Log sheets

· Training Assessments

· Electronic and hardcopy Quality records (e.g. Non-conformance, Corrective and Preventative Actions, Internal Inspection, Change Control, Training Records etc.)

· Certificate of Analysis (CoA) or Certificate of Compliance (CoC)

· Technical transfer reports

· Validation documentation

5.2.3

Common Documentation Errors:

· Missing signature and dates at the time of activity performed.

· The write-over.

· Non-uniform date and signature entry.

· Writing a note that activity was performed on one day and signed for on other day.

· Blank spaces.

· Illegible writing.

· Too many corrections.

5.2.4

General Requirements for Good Documentation Practices:

General Elements	GDP Requirements
Clearly written documentation	All documents must be accurate and written in a manner that prevents errors and ensures consistency. If documents are to be used together, e.g. SOP and a format then each should reference the other. Ensure there is traceability between two or more documents/records using formal document numbers or record identification.
Using indelible ink	All records must be filled out in indelible blue ink ball point pen for long term legibility. Do not use pencil or ink that can be erased.
Legible handwritten entries	A document is unusable if it cannot be read, so care must be taken to ensure that handwriting is legible. All entries must be made at the time the tasks are performed and should be legibly signed and dated. The same is true of electronic documents and records – language should be clear and unambiguous.
Reviewing and Approving	Documents and records should be reviewed by someone who did not perform the task to ensure that the information is correct and accurate. A signature and date by the reviewer/approver confirms that a review has taken place. Unsigned documents or records are incomplete and should not be used to perform any task or considered as evidence of a completed task.
Staff Signatures	Handwritten signatures must be unique to the individual and listed within the site signature specimen signature list to ensure that the signature is traceable to a member of staff (or contractor). Staffs are not permitted to sign for another member of staff unless delegated. Signatures must never be forged.
GMP records are accurate and any changes or amendments are made in a complaint manner	· Deliberately amending or destroying GMP records to hide or falsify data is fraud.
	· Do not discard a GMP record just because you might have made a mistake, it is still required for traceability.
	· It is not acceptable to discard GMP records for any reason unless the retention period expiry is reached.
	· Loose unofficial papers, notes and uncontrolled documents that can easily be lost or changed without appropriate approval do not meet GDP requirements.
	· Do not use notebooks/legal pads with easily removed pages, scrap paper or post-it-notes to record GMP information.

5.2.5

The Following Requirements Outline the Ways in which Handwritten Entries may be Amended.

5.2.5.1

Making legible correction:

If a correction needs to be made, the original record must still be legible:

5.2.5.1.1

Make a single line through the error – never use correction fluid, multiple cross-outs or marker pen to obscure the original record.

5.2.5.1.2

Record the correction close by – 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.

5.2.5.1.3

Put a star mark as (*) and give a brief comment why the change is required (as appropriate).

5.2.5.1.4

Initial (sign) the change so that it is clear that the correction is deliberate.

5.2.5.1.5

Record the date of the correction next to the initials so that there is a record of when the change was made.

5.2.5.1.6

During entering the data on any GMP record incorrect entries are not applicable, if more than three incorrect entries on the same page should be replaced with additional page which is issued by QA and incorrect page should be retained with the same document.

e.g.: The A.R. No. for the finished product is FP/PK/24/001 while entering in to the logbook it was written as FP/PK/24/010,rectify the mistake follow the above mentioned procedure

Date

A.R. No.

01/01/24

* ~~FP/PK24/010~~ Sign/date

FP/PK/24/001

At the bottom of the same page

*(Remark): Wrong entry done

01/01/24

~~FP/PK24/010~~ This is very poor example for correction

5.2.5.2

Handling of Delay in Recording Data:

If an entry was omitted and must be made at a time later than the activity was performed then:

5.2.5.2.1

Clearly indicate the date the activity was performed and the date the activity is recorded on the documentation.

5.2.5.2.2

Document an explanation to substantiate the entry and the reason for the delay in recording.

5.2.5.2.3

Sign and Date the change.

Important: Back dating of entries is not permitted.

e.g.: As shown below:

Standards	UV absorbance
Std 1	1.055
Std 2	0.944
Std 3	0.986

1. Data collected 12/12/24 but not

recorded due to fire evacuation.

Data retrieved from instrument on

13/12/24.

2. Done by : Sign/Date

Checked by: Sign/Date

5.2.5.3

Completing all Fields on a GMP Record:

5.2.5.3.1

If any field or space such as multiple blank spaces, rows, columns within the document which are given for the intention of data entry/record but remains unused due to excess or not applicability then must be marked out with a single line across the whole field or space as shown below.

Data:

A b c ————etc m n o————-etc. x y z————-

N/A

Sign/Date

Date	Result

	N/A Sign/Date

Note:

· A GMP record is incomplete when fields or spaces for entries have not been filled.

· Do not discard a page of a record just because the fields are not applicable because the page could be mistaken as missing.

· Do not use ditto marks to indicate the field is the same as above.

5.2.5.4

Checking Corrections:

5.2.5.4.1

Review the change and ensure that it has been made in a complaint manner – clear, legible, accurate, original entry is still visible etc.

5.2.5.4.2

Review the change with respect to the content of the rest of the document.

5.2.5.4.3

Sign and Date of correction.

5.2.5.5

Recording Numbers:

5.2.5.5.1

Decimal Numbers:

The company GDP procedure should stipulate any specific requirements for recording data. In general, if a decimal value is a fraction of 1 then a zero must be placed before the decimal point.

e.g.: Record 0.98 rather than .98

The number of decimal places to be recorded should be outlined in a procedure.

e.g.: When a specification limit is 2.55 – 2.85 and the result is 2.7, then record the result as 2.70 and not 2.7

5.2.5.5.2

Date Format:

Date must be unambiguous and follow the standard format

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

Dates are to be recorded at the time of activity. Pre-dating or back dating should not occur and is considered as falsification.

5.2.5.5.3

Time Format:

Time must be unambiguous and follow the standard format

HH:MM e.g.: 15:46

The 24 hour format is to be used.

5.2.5.6

Handling

attachments

GDP Requirement

Attachments to forms

Attach one record to another (for example if a report is to be attached to a form):

· Staple the attachment to the record.

· Cross-reference the record and the form with each other, e.g. the

Dealing with Attachments and Printouts :

The following requirements must be met when attaching records and printouts to GMP document:

Handling attachments	GDP Requirement
	The record reference the report number and the report reference the record number.
Attachments to Workbooks/Logbooks	· Secure the attachment to the appropriate page of the Workbook/Logbook . · Do not obscure any data on either the workbook page or attachment. · Ensure sufficient identification on the attachment to ensure traceability in the event it becomes separated (cross-referencing). · Indicate on the original document that there is an attachment. · Sign and date both the workbook and attachment.
Thermal Printouts	· All printouts made on thermal paper must be copied before attaching to a report or filing. Indicate ‘Copy of Original ’or ‘True Copy,’ on the copy and initial and date. · Do not tape over information on thermal paper as the tape will cause the data to rapidly fade. After making a copy, secure the original and the copy with the report.

5.2.5.7

Using Scanned Documents:

Scanned documents, converted to pdf files, are very useful for companies or department operating across different locations. Following table indicate how to treat scanned documentation and other compliance requirements associated with electronic media.

Scanning Document

GDP Requirements

Obtaining Approval Signatures

Obtaining approval signatures from staff located at different sites/locations/time-zones can be completed using scanning rather than hardcopy:

1. Print the document to be approved

2. Sign and date the hardcopy and then scan the hardcopy with the signature.

3. The pdf file of the scan is emailed to the appropriate signatories, who each print out the pdf file, sign and date their signature field, and then re-scan the document and email back to the preparer.

4. The preparer receives a pdf file from each signatory indicating their approval.

5. Attach the signatory page from each approver to the original, hardcopy with the preparer’s hardcopy signature.

Scanning Document

GDP Requirements

6. Indicate on the front page the number of attached signature pages.

7. File all the pdf files in the same storage folder as per the company

policy for electronic versions.

Access to pdf and MS Word Versions

Generally, pdf versions of documentation can be accessed by staff because they are not able to be changed (without specific software).

However, MS-Word files (or equivalent software) can be changed and so should have limited access for most staff (unless other security functions are enabled).

5.2.5.8

Communication Styles Used in GDP

The following table contains suggestions for communication styles useful for GDP.

Actions

How they help

Using words that everyone can understand

(reduce Jargon or Abbreviations)

Unfamiliar words reduce the reader’s understanding of what is written. It can also interrupt their flow of learning if they need to search for the meaning of a word. Therefore, jargon or abbreviations should be avoided if possible, unless well known to the audience.

Definitions of jargon or abbreviations should always be included in the document for reference. This is most effectively done by included the definitions in a table format, at the start or end of the document.

Actions	How they help
Using words with unambiguous meaning	The English language is full of descriptive words which can have different meanings depending on the context, the understanding of the reader and even cultural differences. For this reason, words should be chosen very carefully.
Using whitespace	Ensure that the contents of the document are not squeezed into a smaller area just to limit page numbers. Documents with small margins and no spaces between paragraphs and headings can be difficult to look at, hard and slower to read. Space the contents out so that the type/font is easy to read for all users (consider the overall audience age, or potential colour blindness or dyslexia).
Providing enough detail to make sense of it in the future	When creating a document, consider the context in which the document may be used in the future and whether the reader has enough background information. However, too much non-critical information can also detract from the document and make it too wordy.
Using pictorial or graphical aids (including tables)	Many people remember information best when there is a strong visual prompt, such as a diagram. When the document has to be wordy, consider using tables to structure the information so it is less overwhelming to the reader.
Previous experience and expectations	The level of detail, written style and type of document should all be ruled by the documents target audience.
Consistent wording to avoid confusion	Referring to something by two different names, even if only slightly different, can be confusing.
Consistent styles templates	Consistency with styles will give any document a greater sense of professionalism.

5.2.5.9

Record Control:

In an emergency, if no official means to record an observation is available, then:

5.2.5.9.1

Initial, date and provide a comment on the paper record of the observation and attach to the official hardcopy record as soon as possible.

5.2.5.9.2

Transcribe and attach the data to the official record and annotate ‘Transcribed, see attached original’. The transcription must be signed and dated by the Preparer and filed/stored together with the original record.

5.2.5.9.3

The data must be checked for accuracy by a second staff member.

5.2.5.9.4

Investigate why an official record was not available at the time. Implement corrective actions so that the same situation may not arise again, e.g. create a form for the record, amend the procedure, change the process so that the record is captured electronically etc.

5.2.5.10

Original Records:

5.2.5.10.1

The initial or first record made is the original; for example, the first recorded value entry, computer readable media, non-durable printouts, photographs. If the original record is in electronic format, e.g. an HPLC chromatogram, this can be printed as the original record. This must be then reviewed for completeness and correctness, then signed and dated to signify a true accurate record.

5.2.5.10.2

Unless with good reason, the initial record and the reproduced record should both be retained, even if the original is not durable

5.2.5.10.3

Electronic data and information must be retained and archived on a controlled location; use of a back-up copy is required. The back-up copy must be stored in a secure and controlled location away from the original.

5.2.5.10.4

It is a requirement that the means to retrieve and re-create electronic data is available throughout the shelf-life of the product plus one year.

5.2.5.11

Original Documents:

5.2.5.11.1

Original documents must be controlled against a register or log. Each document must have a unique identifier, in the format required for the document type.

5.2.5.11.2

For any document e.g. a Standard Operating Procedure, only one version can be current at any one time. This is the only document that can be available and in-use. Previous versions are to be removed and are to be retained in accordance with current procedure.

5.2.5.11.3

Externally generated documents e.g. pharmacopoeias, manufacturer’s manuals etc. are to be similarly controlled.

5.2.5.12

Photocopying of Documents:

5.2.5.12.1

All original controlled documents must be marked as ‘MASTER COPY’. Photocopy of master documents may either be marked as ‘CONTROLLED COPY’ indicated by the stamp in blue ink.

5.2.5.12.2

Controlled documents must be issued against a control register; where a controlled document is revised, the previous controlled document returned to Quality Assurance for destruction, according to current procedure and a controlled copy of the new document is issued.

5.2.5.12.3

Where second generation copies are required e.g. formats, these can be taken by photocopying at the time required by the holder of the original copy; these documents are effectively ‘free-issue’. It is the responsibility of the area supervisor to ensure only the correct version number of the document is used.

Abbreviation:

Abbreviation	Expansion
GMP	Good Manufacturing Practice
GDP	Good Documentation Practice
A.R. No	Analytical Report Number
BMR	Batch Manufacturing Record
BPR	Batch Packing Record
N/A	Not Applicable
*	Remark (Reason)
HH:MM	Hour Minute
HPLC	High Performance Liquid Chromatography
e.g.	Exempli gratia
pdf	Portable Document Format
MS	Micro Soft
etc	etcetera

*Note – Ready to use SOP available in “DOWNLOAD” Section.

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