QMS-025 GMP Quality Documentation – Control, Tracking and Distribution

Document Owner

Quality Assurance Manager

Affected Parties

All QA colleagues specially the Document Control Officer.

Purpose

To define the procedure and method of control to create, review, maintain and distribute Quality Documentation.

Scope

This procedure primarily describes the role of the Document Control Officer. Please see the Appendices for Flowcharts of the Quality Documentation System procedural steps

Definitions

Related Documents

EHS Statement

This SOP covers documentation systems only – there is no EHS impact.

Procedure

1.            Creation and Approval of a New Document

1.1.         Initiation

A request for initiation of new document is received via a completed, signed Form-505.  See QMS-010 for definition of document types and data required for each type.  The Document Administrator is to:

1.1.1.     Issue a document number from the Documentation Database.
See SOP QMS-015 for SOP numbering system.

1.1.2.     Raise a new record in the “Quality Documents” area of the Database.
See Appendix 1 for flowchart describing process for raising a new record.

1.1.3.     Complete file properties for the document to be created in the database.  Type in the Status box “To be Written”, the author’s name and the date the record was added.

1.1.4.     External documents i.e. Standards, Compendia, Regulatory Codes etc, utilize the externally derived document number.(See SOP QMS-015)

1.1.5.     Inform the requestor of the document number.  The Document Administrator or the requestor is to create the electronic copy of the document using the appropriate template.  See SOP QMS-015 for templates.  The requester is to save this document in Draft folder. See SOP QMS-015

1.2.         Creating Documents

1.2.1.     All Quality documents are to be based on templates.

1.2.2.     All templates are given unique Template numbers and controlled via the Documentation Database, e.g. TEM-095 is for creating SOPs.

1.3.         Circulation of a new document for Approval

1.3.1.     A notification of finalization of the document is received from the author.

1.3.2.     Update the Status Box in the Documentation Database with “To Be Confirmed” and the name of the first person who is to sign and date the document is forwarded to them (usually the same day).

1.3.3.     Transfer the electronic copy of the document into circulation folder.  Print a copy on White paper.  Make sure the sign off boxes do not have any names and dates typed in, as this copy will be the signed “Master Copy”.

Note:  For Forms the Revision History is to be “hidden text” in the final soft copy version, however the Revision History should be printed on the Master Copy.

1.3.4.     Fill in form Form-395 for SOPs or Form-495 for Forms with the names of the signatories.  Attach this form to the printed document to be circulated.

Note: There are different sign-off requirements for different document types.
See SOP QMS-010 for detailed approval matrix for SOPs.  ‘Prepared by’ is the document author and ‘Checked by’ is usually the document author’s manager.

1.3.5.     TRN (Training) have an additional sign off for GMP by GMP Training Officer or QA delegate as per sign off table on the Training Report Template on TEM-085.

1.3.6.     Forward the document with Form-395 or Form-495 to the first signatory.

1.3.7.     On return of the signed document, update the name and date sent in the Status Box for the next signatory.  Indicate the return of the signed document by ticking across the relevant name on Form-395 or Form-495.  These names should be ticked off in sequence.

1.3.8.     Forward the document with Form-395 or Form-495 to the next person signatory.

1.4.         Amendments to documents being circulated for Approval

If changes to the circulated document are indicated on the circulated copy, the White (Master) must be returned to DCO before the electronic copy of the document is saved into Draft folder again, and then deleted from in Circulation folder, so that the appropriate changes can be made by either the document author or the DCO.

Note: Changes to hard copy only documents are to be discussed with document owner and appropriate action decided.

1.4.1.     Once the changes are made, reprint the document on White paper.

1.4.2.     Attach the changed pages of the document behind the new printout to be circulated.

1.4.3.     Highlight the “Repeats” header on Form-395 or Form-495.

1.4.4.     Update the Status Box in the Documentation Database with “To Be Confirmed” and the name of the first signatory and the date the document was forwarded to them.

1.4.5.     Forward the document with Form-395 or Form-495 to the first signatory.

1.4.6.     On return of the signed document, update the name and date in the Status Box with next signatory.  Indicate on Form-395 or Form-495 the return of the signed document by ticking across the relevant name on the form, under the “Repeats” column.  These names should be ticked off in sequence.

1.4.7.     Forward the document with Form-395 or Form-495 to the next signatory.

1.5.         Issuing of new documents

Once all required signatures are finalised, the Document Administrator will issue the document.  See section 4 for issuing of documents.

2.            Updating and Reviewing Existing Documents

Documents are to be reviewed after a defined period from creation or last update.  See SOP QMS-010 for different review periods for all document types.  Updating of documents may occur at any time prior to required review date if necessary.

2.1.         Reviewing / Updating Existing Documents

2.1.1.     Each month, generate the advice of documents “Due For Review Within The Next Three Months” report in the Documentation Database and send updates to the relevant personnel.  An extension of the review date may be requested.  Note any extension in comments field in the Documentation Database.

A document may be updated prior to the review date if necessary.  A request for updating of the document is sent to DCO.

Note: The appropriate person is to update / review the document.  If required, check with the current version signatories for appropriateness of reviewer.

2.1.2.     Copy the electronic document due to be reviewed or updated into Draft folder for editing.
Note: The current version of the document must remain in the ‘live’ folder.

2.1.3.     Change the Status box in the Database to ‘Under Review’.  Type in the reviewer’s name and the date the electronic copy was placed in Draft folder.

2.1.4.     Check that the document is based on the current template for the specific document type.

2.1.5.     Remove existing signatures and update the version number.

For SOPs and Forms:

– In the “Revision History” at the end of the document, type in the Issue Date (see Database record).

– Then, add a row and type in the new version number, so that the reviewer can add a summary of changes to new version.

– For Forms, change the Font of the Revision History text so that it is no longer “Hidden” text.

2.1.6.     Notify the delegated reviewer that the document is available for editing.

2.1.7.     Follow procedure as for New Documents until end of Approval circulation.

2.1.8.     Once all required signatures are finalised, the DCO will issue the document.  See section 4 for issuing of documents.

3.            Updating ‘Hard Copy Only’ documents

The procedure for change control of hardcopy only documents varies depending on specific document type.

3.1.         Operational & Maintenance Manuals, Project Manuals, Procedural Manuals

Changes are to be annotated to ALL hardcopies and the Manual Approval Change form on the front page of each manual is to have the Change Control section completed.  The text used to describe the change on the Change Control Form must the same on all copies of the Manual.

4.            Issuing Documents

Once all required signatures are finalized, the DCO will issue the document.

4.1.         Saving file to live directory

4.1.1.     Write in the Issue Date and the Review date on the signed hardcopy Master Document.  Type these dates into the electronic copy.  Type the signatories’ names into the electronic copy.

4.1.2.     If a version is being superseded following review or updating, rename the previous version’s electronic copy to include version number.  Move this superseded version into Obsolete folder.

4.1.3.     Save the updated or new electronic copy into the applicable “live” directory. Delete the copy in the circulation folder.  Note that the document is to be saved as the latest version of Word available.

4.1.4.     Complete the ‘File\Properties’ data of each document.  Make amendments where necessary.

4.2.         Updating the Documentation Database

4.2.1.     For existing documents being superseded, print the Document Database record for the document before updating any of the fields.  File this printout in the “Superseded SOPs returned” file.

4.2.2.     Update the Database record with:

– Next version number (remains 0 if new document, or next number for existing documents

– Check the title is exactly the same as in the document

– Applicable names and dates

– Issue date

– Review date

– Document status – “Current”

– Cross Reference to other type documents recorded in “Document Cross Reference” table in the document.

– Any other comments or change in location.

– The required distribution to the satellite file locations.

4.2.3.     Generate “Reading Compliance” forms (From-530) from the Documentation Database by running the “Reading Compliance” reports in the Quality Documentation Reports section of the Documentation Database.

“Reading Compliance” forms will be printed for each satellite file nominated in the Distribution section of the database record.  A copy will also be printed for attachment to the Master File document.

4.3.         Issuing hardcopy

4.3.1.     Print a copy of the document on the appropriate paper type for each Satellite Document file.  Count the “Reading Compliance” forms to determine the number of copies required.

Note: In general, Quality Documentation is printed on white paper with a Red “Authorized Copy” stamp, sign and date.

4.3.2.     Write the relevant Satellite Document File number on the reading compliance form and attach the corresponding “Reading Compliance” form to the back.

4.3.3.     The Authorized Copy should be printed without Revision History.

4.3.4.     File the signed Master document in the appropriate Master file.  Make sure this copy also has a “Reading Compliance” form attached.

4.3.5.     Send the SOPs to the Satellite File Administrators.

4.3.6.     Retain and file the “Reading Compliance” and then destroy the superseded hardcopy Master.  Use secure shredding.

Note: The returned “Reading Compliance” forms are filed according to SOP QMS-010. (They are regarded as training records).

4.3.7.     Generate and distribute a new index to the affected Satellite Document Files.

4.4.         Return of Superseded Copies of Documents

The File Administrators will return all superseded copies of documents, which have been updated.

4.4.1.     Mark off the return of the superseded copies on the appropriate printout of the Document Database record filed in the “Superseded SOPs Returned” file.
VDs are marked off on return of superseded copy.  No “Reading Compliance” is applied to VDs.

4.4.2.     Retain and file the “Reading Compliance” and then destroy the superseded hardcopy.  Use secure shredding.

4.4.3.     Destroy the printout of the Document Database record when all copies of the superseded documents have been retrieved and destroyed.

5.            Cancellation of Documents

Form-505 must be completed and signed before a document may be cancelled. Follow SOP QMS-010 to cancel a document. 

6.            Logging of Technical Files and Standards in the Documentation Database

6.1.         Technical Files

6.1.1.     Log all Technical Files into the Documentation Database and store the hard copy for future reference.

6.1.2.     Allocate a number to each file.  Follow SOP QMS-015 for numbering system used for technical files. Label the file with allocated number on the spine and front of the file.

6.1.3.     Distribution the documents in appropriate compactus.

6.2.         Standards

6.2.1.     Log the documents into the “Standards, Codes and Compendia” sub section.

6.2.2.     Follow QMS-015 for numbering system used for standards. Label the file with allocated number on the spine and front of the file.

6.2.3.     Distribution the documents in appropriate compactus.

Note: Each standard is logged as new, so there could be more than one listing of the same standard.  A search is required to ensure the latest amendment/version is found.

7.            Quality Assurance (GMP) Agreements

GMP Agreements are prepared by the Quality Assurance Department and are written to outline the basic responsibilities and actions undertaken by sponsor and any contracted party who has direct impact in the manufacturing stages of product.

7.1.         Control, Tracking and Distribution of QA agreements (between the sponsor and contractor)

7.1.1      Once the QA agreement is drafted it should be moved from Draft folder to Live Agreements for printing and signing.  Two copies should be printed so that one can be given to each of the contracted parties.

7.1.2     The tracking of QA agreements is done through QA Agreements folder of the database.

7.1.1.     Once signed by both parties the Register of Contracts form (Form-460) should be filled out to ensure tracking of the agreement follows the requirements set out in SOP QMS-110.

8.            Reporting

The Document Administrator runs several reports from the Quality Documents Reports section of the Documentation Database for the tracking of document status.  These include:

– Overdue Review Report

– Documents Due for Review (3 mths)

– Issued Quality Documentation

– Cancelled Quality Documentation

In addition, the Document Administrator monitors timeliness of document creation, review and issue. 

9.            Appendix 1 – DCO – Instruction for Updating or Creating Electronic Quality Documents 

10.         Appendix 2 – Required Data for Document Initiation in Database Record

11.         Appendix 3 – Process Control Regulatory Standards

Summary of Changes