Purpose To describe the procedure for
handling and control of documents
Scope
- This SOP is applicable for Issuance, Distribution, Control, Retrieval and Archival of documents and data ABC Limited. It is not limited to following categories of data.
- Standard Operating Procedures
- Specifications and Standard Testing Procedures of all Raw Material, In-Process Product, Finished Products, Test Data Sheet, Stability Protocol and Packing Material.
- Batch Manufacturing Record & Batch Packing Records
- Quality Manual, Site Master File and Validation Master Plan
- All other quality document which needs controlled and distribution to other department.
Procedure
Finalization of Documents:
- All documents should be identified by a unique title and document number.
- Documents should be designed, prepared, received, approved, signed and dated by authorized persons and distributed to concerned departments.
- Approved documents should not be corrected manually with a pen/ pencil for any reason.
- Executive/Designee of respective department will prepare the require documents. Documents shall be submitted to Head QAD after checking by concerned department Head.
- Final signed original copy of document shall be stamped as “MASTER COPY embossed with sign and date” with Blue colour ink on top left corner of header part of first page of document by Executive/Designee-QAD.
- Second page onwards of document, Executive/Designee-QAD shall stamp “MASTER COPY” without sign and date on top left corner of header part with blue colour ink. All master copy of the quality related documents shall be kept in Quality Assurance department.
Document
Distribution within the Premises:
- Documents such as SOP, Specification, STP, Monthly Schedule and GTP shall be distributed without any request after preparation or revision as follow:
- Executive/Designee-QAD shall photocopy required no. of copies from master document on A4 size white paper and shall ensure photocopy is clear & legible and 100% of original with respect to size and page number. Document can be photocopied both side of page for execution.
- Document shall be photocopied from master document only for any purpose.
- Documents such as planner e.g. Preventive Maintenance Planner, Calibration Planner, Filter Cleaning Planner etc. shall be Master on A3 size white paper and shall be distributed without any request after preparation or revision as follow:
- Executive/Designee-QAD shall photocopy required no. of copies from master document on A3 size white paper and shall ensure photocopy is clear & legible and 100% of original with respect to size and page number.
- Document can be photocopied on one side of page for execution.
- Document shall be issued to concerned department as following
- Distribution of format, logbooks and test data sheet for routine use shall be done as per SOP for “Issuance, Retrieval and Archival of formats and logbooks”.
- Executive/Designee-QAD shall photocopy required no. of copies from master document e.g. Specification and STPs of RM, PM, IP, FP, Stability Protocol etc on A4 size white paper, for operational use and shall stamp as “CONTROLLED COPY embossed with sign and date” at right corner of the header part of first page of document in red colour ink with signature and date.
- Second page onwards of document, Executive/Designee-QAD shall stamp “CONTROLLED COPY” without sign and date at right corner of the header part with red colour ink.
- Photocopied document which shall be used for “Display Purpose” shall be issued with copy no as same as pre-allotted copy number to the concerned department and shall stamped as “CONTROLLED COPY FOR DISPLAY embossed with sign and date” at right corner of the header part of first page of document in green colour ink along with signature and date. Second page onwards of document, Executive/Designee- QAD shall stamp “CONTROLLED COPY FOR DISPLAY” without sign and date at right corner of the header part with green colour ink.
- Batch Manufacturing Record, Batch Packing Record shall be distributed as per their respective SOPs. Other Documents such as but not limited to below shall be distributed
- Specification and Standard Testing procedure
- Site Master File
- Validation Master Plan
- Layouts and Drawings
- Planner and Schedules
- Approved Vendor List
Distribution
of Documents outside the Premises or outside Agency
- Executive/Designee of concern department shall send request for uncontrolled document to QAD.
- Executive-Designee-QAD shall make photocopies of the requested document from the master document.
- Photocopied document shall stamp “UNCONTROLLED” diagonally in black colour ink on every page in such a way that the stamp should be over the text matter not in blank space at the center of the document.
- Uncontrolled copy shall be issued to the customer/vendor for reference purpose outside the premises which shall not be controlled by means of use and retrieval.
- In case of any document which needs to distribute to vendor/customer or any, uncontrolled scanned copy of such document shall be distributed through mail.
Issuance of
Documents for Reference:
- Whenever any old submitted document is required by the concerned department for review or reference purpose, concern department shall give written request to Executive/Designee-QAD with reason after authorization from department In-charge as per Reference Document.
- The request shall be reviewed by Head -QAD/Designee and if given reason is justified request shall be approved by Head-QAD.
- After approval of the request note, Executive/Designee-QAD shall issue required document to concern department.
- After completion of the purpose for which the document was requested by concern department the document shall be sent back to QAD for their control and concern person shall sign in submitted by column.
- Executive/Designee-QAD shall than keep the record back into the record room after making required entries.
- Retrieval of the Documents:
- Whenever any documents are revised Executive/Designee-QAD shall retrieve all the controlled copies of old version document from all departments as per distribution record and shall destroy either manually by shredding into pieces or through shredder and record of the retrieval and destruction shall be maintained.
- The Original documents i.e. Master Document of old version shall be stamped as “SUPERSEDED” diagonally in red ink at the center of each page in such way that the stamp shall be over the text matter not in blank space and shall retain in QAD for reference.
- The Revise document shall be issued to the respective department by Executive/Designee-QAD and record of the issuance shall be maintained.
- In case any quality document which shall not be used in future, Executive/Designee-QAD shall retrieve all the controlled copies of old version document from all department as per distribution record and shall destroy control copy either manually by shredding into pieces or through shredder and record of the retrieval and destruction shall be maintained.
- The Master copy of such documents shall be stamped as “REDUNDANT” diagonally in the red ink at the center of every page in such way that the stamp shall be over the text matter not in blank space.
- Tracking of the documents for review:
- Document shall be reviewed based on the defined frequency. These limits are maximum limits which doesn’t restrict for revision of document if review and revision required earlier.
- Standard Operating Procedure : Every Year
- Specification and STPs : As when required
- Validation Master Plan : Every Year
- Site Master File : Every Year
- Manuals and Policies : Every Year
- Executive/Designee-QAD shall prepare an annual plan for review of each type of document in “Document Review Plan” and shall follow-up with the responsible persons to ensure compliance with the plan.
- Document due for review shall be identified from the Document Review Plan for the upcoming month. Based on review, a change control shall be initiated (if any change required) as per the SOP for “Change Control”.
- If there are no changes identified during review, document shall be stamped with “VALID UPTO ………..”(Date) on top center of all pages in green color of old master document & put the sign along with date of stamping. Date of stamping shall be considered as effective date of document.
- If further review suggests no changes, document shall be reprinted with new version number and issued for implementation. Old master copy shall be retained after stamping superseded and archived in QA department. Training may not be required for the documents which are reprinted without any change.
- In case, document is not revised within the validity date, a deviation shall be initiated by the concern department as per the SOP for “Handling of Deviation”.
- All the documents shall be prepared. Reviewed and Approved as per their respective SOP.
- Retention Period of the Document and Data:
- All the documents shall have its document retention period. The retention period of all the documents shall be followed.
- All the records after completion or after review shall be submitted to QAD. Executive/Designee-QAD shall verify the record and keep under lock and Key in record room.
Destruction of the Documents:
- After completion of the retention period of the document. The document due for destruction shall be listed by Executive/Designee-QAD and shall be destroyed after approval from Head-QAD and shall maintain log record of destruction.
- Head-QAD/Designee shall authorize to enter & access the record room. Record shall be accessed after making entry in record room access record log by authorized person
- Access logbook shall maintain in the record room. Authorized person shall keep lock closed & shall be opened only when require.
- QA Head/Designee will review the documents and approve or reject the documents.
- Data may be recorded by electronic data processing system or other reliable means, but batch records and detailed operating procedures relating to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records.
- Wherever document is handled by electronic data processing methods, authorized persons shall enter modify data in the computer. There shall be record of changed and deletions. Access shall be restricted by “Password” or other means and the result of entry of critical data shall be independently checked. Batch records electronically stored shall be protected by a suitable back-up. During the period of retention, all relevant data shall be readily available.
