Good Documentation Practices (cGDP)

Requirement for Good Documentation Practices (cGDP)

Here are the some Good Documentation Practices (cGDP) in different way is listed as below,

Good documentation practices for Manual/Paper documentation

All documents must be precise and written in such a manner that prevents/avoids errors and ensures consistency. Documents shall have unambiguous or clear in manner that it should contents; the title, nature and purpose shall be clearly stated.
Documentation shall always be done in accordance with applicable written procedures following ALCOA ++ elements.
Good documentation practices (GDP) should be followed in order to ensure that, all records allow full reconstruction of related activities.
All documents should have a unique document number, title, effective date and version (where applicable). Pages in the document shall be numbered as X of Y (e.g., Page 2 of 20).
All documents shall have the signature and date of the person who prepared, reviewed and approved the document. The roles or responsibilities of reviewer and approver shall be defined.
Changes or revisions to documents shall be assessed to check the impact and handled through a review and approval process of change management (where as applicable).
The use of uncontrolled documents shall be prohibited by local procedures.
The use of temporary recording practices, e.g., scraps of paper, shall be prohibited.
Documents should be regularly reviewed and kept up-to-date. When document has been revised, systems should be operated to prevent unintended use of superseded documents.
Signing not as per the specimen signature mentioned in the “Specimen signature record ” is not permitted.

Review and approval of documents

Documents within the Quality Management System (QMS) shall be regularly reviewed and kept up to date.
- When a document has been revised, a system shall exist to prevent inadvertent use of the superseded version.
- Superseded documents shall be retained for a specific period of time.
- Unsigned, Without any authority signed or incomplete documents or records shall not be used to perform any task or considered as evidence of a completed task.
- All records must be signed and dated by the person who has generated the record.

Unsigned or without dedicated signed documents or records shall be measured as incomplete and shall not be used for execution any task or shall not be acceptable as an evidence for a completed task.
- Documents shall be approved, signed and dated by the appropriate responsible persons. No document shall be changed without authorization and approval.
- Training on the document shall be scheduled only after final approval of document and shall be accomplished before the effective date.
- Prepared By , Reviewed By and Approved By shall be different user and all GMP documents shall be approved by Quality Assurance.

Issuance of documents

The formats or records associated with the activity shall be part of respective SOPs.
Master copies of controlled documents (paper-based and electronic) must be stored in a secure manner and accessible only to authorized individuals.
Records shall be preserved for issuance and retrieval of formats with proper traceability of the person who issued the document and the date and time when it was performed/issued.Appropriate procedures shall be in place to control distribution of documents within the organization.
Reconciliation of issued documents shall be performed and recorded in the respective issuance log.

Data Entry in cGDP

Indelible ballpoint pen shall be used to record data. Pencil or erasable or water-soluble ink pen shall be prohibited to complete the GMP (Good Manufacturing Practices) documents (unless otherwise specified).
The written entries must be clear enough so that they are readable when the data entered documents are photocopied or scanned.
The data must be entered in English language.Data must be recorded on prescribed, controlled formats/ registers/data sheets.
Temporary records such as paper chits, post – its, pencil mark are not permitted to record the (as per Good Laboratory Practices (cGLP) documents.
Handwritten entries shall be made in a clear, legible, indelible manner.If data has been erroneously struck off, appropriate justifications shall be provided along with signature and date.
It shall be ensured that the time displayed in all the systems, computers, Instruments and clock of all department is synchronized by an authorized designated person or department.Data recording shall be done by trained and authorized persons.
A photocopy of unstable document (thermal paper printout from instrument) should be taken and then attached to the document for traceability. The print out should also be attached along with it.
Markings such as Ditto ( –”– ), “ as above” or “do” shall not be used. Records should capture the actual and clear observations.
Shortcuts in the GDP such as putting remarks like OK/Not OK, Comply, Done. etc., shall not be adequate (Unless and until not specified in SOP). However, in certain formats like checklists, where the activity is to be conducted and recorded, “Yes” or “No” shall be written indicating whether the activity was performed or not performed.
The same shall be signed by the person executing the checklist.
Use of brackets such as curly brackets “{ }”, square brackets “[ ]” against multiple entries must not be permitted. For example, remarks as shown below are not acceptable:

Requirement for Good Documentation Practices (cGDP)

Print outs from instruments such as chromatograms must have details of Batch No., Instrument ID, stage/ conditions (for in-process, stability batch respectively) to permit audit trail.
In case of blank fields wherein striking out is not feasible, “NA or Not Applicable or –NA-” shall be mentioned. This shall indicate that the blank space was not skipped or forgotten while making entry.
Long signatures shall be used for signing of approval page or signing off a master document, report or record.No one should ever sign or initial for someone else unless delegated by management.
Signing for an activity in advance or signing for an activity with back date is prohibited.

Procedure for Dating and Timing a Document

Date wherever entered for document authentication should be entered in DD/MM/YY (Which ever format suite to any organization) format in blue ink and should have “/”as separator. For example: 1st February 2019 should be written as 01/02/19.
24- hour time format (HH:MM) should be followed for all the GLP documents.
Date and time format may vary in software generated print outs, weight slips, chromatograms, spectrum as per pre-set format in respective software. Such printouts shall be exempted from above mentioned date and time format requirements.

Handling of Missing Entries and Corrections in Good Documentation Practices (cGDP)

Any changes or corrections to manual entries must be made in online contemporaneous/concurrent) documentation, and the entry’s initial author must sign and date the document. In the event that this is not feasible, Quality Assurance must be informed.
The incorrect entry must always be marked with a single strike-out line so that the initial entry is still legible. Write the right entry close to the strikeout entry. It is required to document the cause for the alteration, such as a transcription mistake, typographical error, recording error, calculation error, etc.
As a case study: If an analyst enters a date incorrectly in writing,

Wrong way: 10 01/02/19 WE (Sign/ Date)

Correct way: ~~01/02/19~~

10/02/19 WE (Sign/Date)

The codes that may be used are:
- WE =for Writing Error
- CE = for Calculating Error
- TE = for Typographical Error
- SE= for Stamping Error
- ME = for Missing Entry

When an error cannot be addressed by any of the above mentioned codes, an asterisk (*) or any other sign should be made besides the mistake; correction should be made, initialled and dated.
The reason for the correction should be given at the bottom or suitable place of the paper with the reference of (* or any symbol). The reason should also be initiated and dated by the initiator of correction and checked/approved by function in charge and QA where applicable.
Avoid same symbol in same page, so it can be easily identified by reviewer.
Missing entry in the GMP documents for non-retrieval data shall be handled through proper QMS procedure.
If during review, any entry or signature is found to be missing and if a suitable evidence for execution of that entry or presence of that person in that process is available, then a symbol (*, @, # etc.) shall be done at the place where entry/signature is missed and at the bottom of that page a remark shall be mentioned with the correct entry and reason which shall be initialled as on current date.

Procedure for Affixing attachments/ print-outs to Documents in Good Documentation Practices (cGDP)

When an attachment/ print-out is to be affixed to a document, it should be done by extending signature and date from the attachment to the document where it is affixed, so that if the attachment is removed it will be evident from the residual signature on the document.
The attachment or printout is to be affixed with glue stick at designated place.
The name and number of attachments/annexures to the original document shall be provided in the original document. Cross reference should be provided in the attachment/annexures attached to the original document and vice-versa.
Ensure sufficient identification on the attachment to ensure traceability in an event it becomes separated from the original document.

Good documentation practices (cGDP) for electronic documentation

Appropriate roles shall be defined with relevant privileges on the electronic system to ensure that there is no overlap of roles.
- Access to the master templates shall be controlled.
- Access control shall be provided two level controls (unique username and password) or suitable process.
- Revision of electronic documents shall have the revision history on the document and routed through suitable QMS process.
- Prepared By, Reviewed By and Approved By in electronic signature shall be different user (whereas applicable).
- Audit trails that capture changes to critical data should be reviewed with each record before final approval of the record.
- Electronic data shall not be destroyed. All electronic data shall be perpetual/ permanent.
- De-mounting of Data or Data modification or deletion shall be tracked through an audit trail and shall be documented with suitable reason.

Document Review

The major correction or gaps identified in approved documents shall be addressed through the revision of the document.
The minor correction identified in approved documents shall be addressed through the Errata Sheet

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