DOCUMENT AND DATA CONTROL IN PHARMA
OBJECTIVE:
The purpose of this Standard Operating Procedure (SOP) is to lay down a procedure for issuance, Retrieval and destruction of various documents to ensure that correct versions of document are in use.
SCOPE:
This SOP is applicable for issuance, distribution, retrieval and destruction of Standard Operating Procedures, Master Formula Records, Specifications (Raw Material Specification, Packing Material.
Specification, In-process specification, Finished product specification), Facility layouts and drawing,
Validation /Qualification Protocol & reports, Artworks, Validation Master Plan, Data Recording Forms & Log books uses.
RESPONSIBILITY:
Officer/Executive of Quality Assurance shall be responsible for scanning, storage, print, issuance, control, numbering, distribution, retrieval and destruction of various forms of documents.
Officer/Executive of requesting department shall be responsible for request and receipt of documents as per requirement.
Manager Quality Assurance shall be responsible for the implementation of SOP.
ACCOUNTABILITY:
Head – QA.
PROCEDURE:
Issuance of Documents:
After approval/authorization of the applicable document by Head Quality Assurance /Designee document shall be given to user department for training and usage (if applicable).
Applicable documents shall be submitted to QA for implementation (making effective) along with, filled form no. QA/002/F08-00 (Issuance and retrieval checklist) for each document and uncontrolled copy of training attendance sheet (if applicable) for further processing.
Original training records shall be stored in originated departments shall be made available during inspection.
QA Documentation cell shall verify the filled form no.QA/003/F08-00 for retrieval of the issued documents.
Effective date and review date shall be given after training (if applicable).
Quality Assurance cell shall stamp “MASTER COPY” (red in colour) on the middle of top of all pages of documents.
QA department shall be custodian of all documents having stamp “MASTER COPY” and these documents shall be kept under lock and key.
Scanning of the master documents shall be done and shall be kept in segregated folders as per type of documents and print can be taken from scanned documents for any issuance purpose by QA personnel.
If any revision occurs in any master scanned document, the same shall be replaced by next revised version document and superseded version shall be transferred to superseded folders.
Issuance of Standard Operating Procedure, Specification, General Test Procedures, Master Formula Record, Product Information Form.
Quality Assurance person shall stamp with “CONTROLLED COPY” (Blue in colour) /”DISPLAY COPY” (Blue in colour) and handover to Officer of Quality Assurance for issuance of controlled/display copies.
The issuance of controlled / display copies shall be restricted to Quality Assurance department. All the department shall have a unique Copy Number as given below:
Copy No. shall assign as “XX”.
Where XX stands for serial number starts from 01, 02, 03 and onwards.
Example: One copy (Controlled copy) issue to user department in that case copy number shall allocate as 01.Another copy of same document (Controlled copy) issue to other department/ other location in that case Copy No. shall allocate as 02.
Officer/Executive Quality Assurance shall record the issuance detail in document issuance, distribution, and retrieval and destruction log as per (Format No.: QA002/F01-01).
Issuance of individual forms, Worksheets for Analysis, Validation Protocol Annexure (Annexure) for execution.
Work sheet shall be issued in package for single use along with required forms and all the information.
After completion of analysis the package shall be enclosed with respective BMR of the product by QA personnel on receipt from QC.
FP analysis report shall be enclosed with respective BMR of the product by QA personnel on receipt from QC.
Other work sheet package (reports) shall be submitted to QA on monthly basis (and if any analysis is pending or is ongoing, the package shall be submitted in next coming month after completion of the analysis).
Other forms which are not part of work sheets shall be submitted to QA on monthly basis.
Usage copy of Annexure of the protocols shall be achieves with reports and package (report) shall be submitted to QA on monthly basis or after compilation of the validation report of the particular Validation.
QA personnel shall mark the retrieval of the forms on monthly basis on Format no. QA002/F05-01).
Retrieval of the work sheets package of finished product analysis (other than stability report) and annexure of the protocols shall not be done individually but after receiving of the complete package (report), the same shall be marked as retrieved by QA personnel after verification.
Raw data package issued for stability study shall be submitted to QA along with report after each stage (station) and after completion of the study.
Officer or designee of requesting department shall request to QA document cell through inter office memo (Form No. QA002/F06-01).or in any defined form (if specified any) for requirements of forms/worksheets/protocol Annexure by mentioning Name/Form No./Annexure Number along with reference protocol required for execution.
After receipt of request, Officer/designee of QA document cell shall print the required master documents and handover to the QA technician.
QA technician shall stamp us “USAGE COPY” (Green in color) bears. “Sign. / Date” on each page and serial number (By auto numbering stamp) on first page.
Serial number shall start from 01 from 1st January of the calendar year in a continuous series for all forms / worksheets/annexure for all departments.
After stamping QA Technician shall handover the forms / worksheets to Officer / designee of QA documents cell for issuance.
Officer/designee of QA document cell shall sign/date on each page of documents.
After signature Officer/designee of QA document cell shall enter the details in log as per Format No.: QA002/F05/01).
Handover the documents to the person of requesting department along with Form reconciliation sheet per form no. QA002/F07-01).and takes signature of person who receipts the same on required log.
User department shall submit the completed form reconciliation sheet to QA document cell on a monthly basis or whenever is required and QA personnel shall check the reconciliation form for completeness and correctness.
New format shall be issued after submission of the reconciliation sheet QA.
Issuance of Formats/Log books (Binding):
Note: At the time of issuance of log books, un-numbered pages shall be crossed diagonally and NA to be mentioned with sign and date.
Officer or designee of requesting department shall request to QA document cell through format no.: QA002/F10/00 for requirements of Formats/Logbooks mentioning title of log book, form number and number of log books required
Officer / designee of QA document cell shall fill the detail on log book and sign/date at specified place.
After signature Officer/designee of QA document cell shall enter the name of Log book in Logbook issuance, distribution, retrieval form (Logbook) (as per Format no.: QA/002/F3/00) and retrieve the old log book, if applicable.
Handover the log book to person of requesting department and take signature of person who receipt logbook.
On yearly basis or after completion of the log book or after any revision in master form of the log book whichever is early, user department shall submit the executed log books to QA documents cell for archival.
Officer/designee of QA document cell enters the retrieval of logbook in the Log Book issuance, distribution, retrieval form (Form No.: QA002/F03-00).
Issuance of Formats/Logbook (Perforated forms):
Officer or designee of requesting department shall request to QA document cell through format no.: QA002/F10-01 for requirements of Formats/Logbooks with proper details i.e. Form Name, Form Number, requires for execution.
After receipt if request, Officer/designee of QA document cell shall instruct to the QA technician for taking the logbook from document cell custody as per request.
Officer/designee of QA document cell shall fill the details on perforated log book and sign/date at specified place.
Officer/designee of QA document shall issue the log book with required details on log book.
After signature Officer/designee of QA document cell shall enter the details in Log Book issuance, distribution, retrieval logbook (as per no.: QA002/F03-00) and retrieve the old book, if applicable.
Handover the logbook to person of requesting department and take signature of person who receipts logbooks.
On yearly basis or after completion of the log books or after any revision in master from of the log books whichever is earlier, User department shall submit the log books to QA documentation cell for archival.
Officer/designee of QA document cell enters the retrieval of logbook in the Logbook issuance, distribution, retrieval form (as per Format No.: QA002/F03/01).if applicable.
Issuance of Validation Protocol and Reports:
All master validation protocols, final reports, shall be stamped “Approved Validation Documents” on front page only by QA officer/designee before scanning for master folder and the documents shall be kept under jurisdiction of Quality Assurance Documentation cell.
As per requirement, print of the Master scanned document shall be taken and shall be “Sign/Date” on first page and QA ISSUED stamp on each page of protocol/report.
Officer/ Executive Quality Assurance shall issue the controlled copies as per requirement by entering “Copy No and Sign/date” on the stamp.
Officer/Executive Quality Assurance shall record the detail in Document distribution, retrieval and destruction records as per form no.: QA002/F01/01).
Note: Controlled copy should not be used for filling of raw data.
Officer/Executive Quality Assurance shall record the details in Document issuance, distribution, and retrieval and destruction log as per (Form No.: QA002/F01/01).
After completion of validation activity, Validation department shall enclose the controlled copy of protocol and report with raw data of each particular validation activity and same package shall be submitted to QA.
Validation department shall raise request for issuance of controlled copy of protocol prior to execution of each validation activity as per validation planner.
A formal and comprehensive validation documentation index shall be updated and approved by Validation management and handover to Quality Assurance, at the frequency of month to reflect all current applicable validation documentation.
Issuance of Artworks:
Officer or Designee of Quality Assurance shall stamp as “MASTER COPY” (red in colour) on the original copy.
Master copy quality document shall be colour scanned and required copy shall be printed (coloured) from scanned PDF.
Technician Quality Assurance shall “Sign/Date” and issue on all copies to be issued.
Officer/Executive Quality Assurance (Authorized Copy Holder) shall record the numbers of the copies (write the same numbers as written on controlled copies) in Document distribution, retrieval and destruction record.
Issuance of Drawings:
Officer or Designee of Quality Assurance shall stamp as “MASTER COPY” (red in colour) on the original copy.
Master copy quality document shall be colour scanned and required copy shall be printed (coloured).
Technician Quality Assurance shall “Sign/Date” on all copies to be issued.
The issuance of controlled/display copies shall be restricted to Quality Assurance department.
Officer / Executive Quality Assurance shall issue the controlled / display copies as per requirement by entering “Copy No and Sign/date” on the stamp.
Officer / Executive Quality Assurance shall record the numbers of the copies (write the same numbers as written on controlled / display copies) to be distributed in Document distribution, retrieval and destruction record.
Retrieval of Documents:
Required copy of the effective documents shall be made by QA Documents cell before the effective date and can be issued to department before or on effective date.
Section Head shall keep these issued documents in his custody shall hand over to department for use on effective date.
All copies of obsolete documents which are in circulation and identified in form no. QA002/F07/00).shall be taken in custody of department head before handing over the revised documents to the operational area.
All copies of obsolete documents which are in circulation and identified in form no. QA/002/F07/01).shall be submitted to QA within 15 working days.
Circulated superseded or obsolete documents shall be destroyed by QA and record into respective logs.
Returned controlled/display copy of document shall be destroyed by QA and records into respective logs.
Master copy of superseded version shall be stamped as OBLOLETE on the same day when the next version of document is being effective and stored in lock and key as per specified retention period.
Issuance of Executed Documents:
Issuance of filled / executed document shall be done only after receiving approved written requisition from the Head of requesting department and authorized by Manger Quality assurance as per Form No. QA002/F07/01).
Only uncontrolled copy of executed documents to be issued.
Issuance of Uncontrolled Copy of Documents:
Uncontrolled copy shall be made either by stamping “Uncontrolled Copy” Stamp on photocopy of any authorizes/official documents or uncontrolled copy shall be printed. (Photocopy of uncontrolled copy documents does not require another stamp and can be used directly for reference).
Master document shall not be given to any unauthorized person and only uncontrolled copy shall be provided for any reference purpose and photo copy of controlled and Display copy documents is strictly prohibited.
Any document (master/or executed) shall not be sent outside the premises without making uncontrolled copy by QA.
If any document is required for attachments as reference of any task or activity, QA document cell shall issue uncontrolled copy of the same. (Uncontrolled copy shall be printed).
If any area needs the control copy of any documents (other than specified) shall fill the Form No. (QA002/F02/01).
Document Retention:
Documentation shall be stored under the custody of Quality Assurance in Lock & Key with restricted circulation for the corresponding periods defined below.
| Type of Record | Minimum Retention Time (Years) |
| Product design and development history file (including but not limited raw data used to support submission) | Permanent |
| Regulatory submission (Including Stability records/raw data used to support submission) | Permanent |
| Trials batch record/Process validation / Exhibit batches | Permanent |
| Production Batch Records | Four year from the date of manufacture or Expiry date + 1 year whichever is greater. |
| Master BMR/BPR | Permanent |
| Master formula record | Permanent |
| Distribution records of drugs | 3 years after product distribution |
| Product disposition forms | 3 years |
| Temperature Charts | 3 years |
| Product complaints (Medical and ADE) | Permanent or 10 years after the Product is discontinued |
| Product complaints (Nonmedical) | 6 years |
| Litigated complaints | Retain until destruction is approved in writing by Management (based upon legal counsel) but not less than the retention time indicated above for Medial and Non – Medical Complaints |
| Product component records (Purchased or manufactured drug/chemical record) | 6 years |
| Product component records (Non-DRUG) Commodity records | 5 years |
| Calibration Record : Dedicated instruments (to a specific product type) | Permanent or 3 years after removal of the product type from the market place |
| Calibration record : Non dedicated instruments | Permanent |
Quality Audits:
|
|
| Field Action Records (Recalls, withdrawals) | 6 year |
| Post Marketing stability records (not part of a regulatory submission) | Permanent |
| Validation records | Permanent or 4 years after termination of process/test/software/facility/equipment) |
| Training records and job description | 6 years after separation from company |
| Product specification (e.g., Test methods, etc.) | Permanent (or 6 years after the product is discontinued if filed by list number or product Name) |
| Standard Operating Procedure (Including obsolete documents and associated revisions) | Permanent |
| Purchasing records (for non-components) Purchase Order, Contracts, Supporting records. | 10 years from close of order or expiration of contract. |
| Records associated with closed or Decommissioned facility or operation areas | Permanent |
Documents shall be stored in a segregated manner for easy identification under lock and key in document storage room.
Removal and issuance of documents shall be done after due authorization by Head-QA.
Destruction of documents after completion of its retention period shall be done after obtaining permission from Head-QA and such records shall be maintained as Expired Document Destruction Record QA002/F04-01.
Superseded copy of documents which are to be destroyed shall be kept in tray having the label “Documents to be destroyed” and documents shall be destroyed/shredded after re verification by QA Officer/Designee.
All the soft copy of the document being effective shall be handed over to QA documentation cell In-charge/designee through email or to be shared in Shared Folder of Quality documentation cell and in-charge/designee QA documentation cell and in-charge/designee QA documentation cell shall keep them in specific folders.
QA shall share current version documents to user on request, for any revision.
The documents like administrative documents, legal documents, Finance related documented, Invoices of warehouse department etc, which is not related to any CGMP shall not have any watermarks and shall be printed through ordinary printers.
Effective Date and review date shall be hand written as below date format.DD MM YYYY (Font Size and font type is not specified but shall be uniform for all documents)
Where DD = date is numeric, for example 01, 02, and so on.
MM= month in alphabetic, for example 01, 02…and so on.
YYYY = year in numeric, for example 2016, 2017…and so on.
ENCLOSURE:
Document issuance, distribution, retrieval and destruction of forms.
Requisition form for Issuance of Executed Document/Extra copy of Document
Log Book issuance, distribution, retrieval form
Document Destruction Record
Form/Worksheet/Annexure issuance, Distribution form
Template of Inter Office Memo.
Form Reconciliation Sheet.
Issuance and Retrieval Checklist
Logbook Issuance Record
Format/Logbook Request
