How to control documents & Data

 

 Document control over-all system of an organization or company for accessing, reviewing, revising, approving, disposition, and obsoletion of documents, data, and software. Document control plays such a major role in defining the quality standard.

 General requirements of documents control:

• Master document lists shall be prepared  to index SOP of all departments, standard test procedure, specification, Process validation, BMR/BPR, qualification of all production equipment(s),quality control instruments, utility equipment(s), instruments identification etc.

• In case any new document introduced or old document revised, respective Master Index shall be updated manually in addendum sheets of each index immediately and on quarterly basis it shall be updated computerized.

• Documents shall be generated by the user department on the basis of references SOP’s and guidelines. This document shall be prepared by one person and  checked by / reviewed by another person for its implication and then sent to quality unit for approval and implementation.

• Language used for generation of a document should be clear & unambiguous. Where ever required, the document in local language or pictorial documents can be prepared for better understanding & clarity e.g. SOP for glassware cleaning, housekeeping ,gowning procedure, can be prepared in local language. if any changes in the approved documents is require, shall be changed followed by  permanent change control procedure.

Document control,Distribution and Retrieval

1. The master copy of the approved document shall be prepared by stamping “MASTER COPY” using green ink, on the top right hand corner of each page. Generation of master copy shall be done by Quality unit and same shall be archived. All approved copies shall also be considered as master documents.
2. Execution of activity shall be done on control copy of master copy , however control copy shall be prepared  a photocopies of “MASTER COPY” on white suitable size paper using one side of the page , Each page of the controlled copy shall be stamped as “CONTROLLED COPY” using red ink, at the right hand side of bottom corner of each page mentioning the department code & copy no. with initial signatures and date. If any master documents wants to display, a control copy of master document can be displayed,Each distributed documents shall be recorded with signature and date of the recipient in the “Document distribution and Retrieval Record”.
3. when a documents send out side of the premises or control , an uncontrolled copy of the document,  shall be stamped as   “UNCONTROLLED COPY” using black ink, at the bottom right hand corner of each      page. ‘UNCONTROLLED COPY’ and send it, and it is not retrieval. 
4. While issuing the controlled copy of revised document, the old version controlled copies shall be retrieved and destroyed as per written procedure and master copy of old version shall be stamped as “OBSOLETE” at center of each page diagonally.
5. In case, if data preserved in the form of CDs / DVDs / Any other electronic storage device like drives & data travelers, shall be labeled with details sign/date & shall be preserved appropriately.If need arises for an additional copy or document for reference purpose of SOP’s, master documents  or archival document etc, the concerned Department shall give a request to the Quality unit  as per described requirement request form. When controlled copy of issued format is required for reference like change control, deviations, market complaint, training records, online rejection note; a photocopy of the document shall be stamped in  Blue color “REFERENCE DOCUMENT”put on bottom at center of each page.

 Format control and Issuance 

1. All formats originating from the SOP's should be stamped as “MASTER COPY” along with the SOP's. Formats shall be issued with approved stamp on the top left hand corner of each page of the photocopy of “Master Copy” with sign and date of QA for multiple uses, as request form which will request to issuance of documents. 
2. The user department shall send a request to Quality unit  as per requirement, for issuing the formats / documents, mentioning their requirement for the type of documents/formats and quantity required,same shall be issued with maintaining its issuance records. user department shall ensure that issued format should use only data recording.

Handling and Control of Superseded Document

1. If any changes occur in the existing / current documents, document shall be revised followed by change control system, the version of the revised document shall be changed with the new effective date.The revised document shall be considered as current one and previous version as superseded.
2. All controlled copies of superseded document shall be collected directly from the user department by Quality unit before handing over the current version of document.The retrieved copies (controlled copy) shall be destroyed either by shredding or incineration and master copy of superseded version shall be stamped as “OBSOLETE” at center of each page diagonally and archived as document management system.

  Documents Review & Revision

1. The documents like SOPs, Specifications, STPs, ATDS, and GTPs shall be reviewed every two years.If these documents require revision in the procedure before their review period, these can be revised followed by change control procedure. the review of documents shall be completed within ± one month from date of ‘Review Date’ assigned on the concerned document.
2. In case no change is required in an SOP or STP or ATDS or Specification, the document shall be stamped for re-issuance as per defined in-house procedure. In case there is revision of SOP but the change does not impact the formats, the formats need not be reissued (at least not more than two revision cycles).

 Data Entry , Rectification & Control  

1. Data shall be entered into records with permanent (indelible) blue ballpoint pen by all user departments while quality unit shall use another color(e.i black or green) permanent (indelible) ink pen. Non-waterproof ink, Erasable ink & pencils shall not be permitted. All manually recorded or entered data shall be verified by a checker (same department or other quality unit where ever require).
2.  Dates shall be filled in DD/MM/YYYY and time on 24-hour clock basis  format  e.g. 15:30 & 03:30 where 15:30 means 03:30pm 'afternoon' & 03:30 means 03:30am at 'midnight',The Handwritten Date & Time on a document will be the current date & time at the location where the handwritten entry is made. However entries must be made at the time of completing the task.
3. No handwritten changes or corrections will be made to the printed text of an approved cGMP document. Any rectification or correction of data shall be handled only defined procedure  in executed documents, Such changes shall only be acceptable if supported by an approved change control or deviations number and raw data shall be verified by concern responsible person.
4. When making a correction to a manually written record on a controlled document following steps shall be followed:

• Place a single line through the incorrect entry, Initial signature and date the adjacent to the cross-out. Enter the correct data near the original entry. It is recommended that when there is correction on the critical data like weights, time etc. changes/correction are supported by an appropriate justification.
• When the reasons for the correction is obvious, place an asterisk or number next to the incorrect entry and explain the correction at the bottom of the page, identified by the asterisk or corresponding number with a sign & date.
• The mistake must still be legible through the cross-out.
• No one shall enter a signature or initials for someone else. 

All entries must be made directly on to the official record or document. The use of scrap paper or unofficial notes to record data is not permitted. All documents requiring review and approval signatures shall contain the original handwritten signature and date signed. Signatures made by rubber stamps, preprinted labels photocopy or faxes are not permitted.

Where, the multiple options are available e.g. Yes/ No or statement like “tick the appropriate”, the choice of option shall be clearly defined by putting a tick across the choice. The other options shall be crossed out.  Blank spaces are not permitted in any record. In the event, an item in a record is not applicable; ‘NA’ shall be entered or “-“dash shall be put in a manner that prevent misuse of the space after completion of activity. If “remarks column” is available in a recording format and no data is too entered after completion of activity, then put “NA or –“to close the space.

Retention Period for Records / Documents

1. All masters (e.g. SOP/Specification/STP/ATDS/BMR/BPR/SMF/VMP) shall be permanently archived. Qualification and validation documents (including process validation reports and batch records), VMP, Methods for analysis, Vendor Reports, stability summary sheets Product Quality Reviews, destruction records, dossiers, risk assessment/CAPA, shall be archived for life (permanent). Documents submitted to regulatory agencies shall be archived permanently. The complaints received from regulatory agencies and the response shall be permanently archived. The documents shall be prominently identified for the status, the trend of water & environment monitoring shall be archived permanently.
2. The executed documents like BMR / BPR, filled Analytical data sheets, analytical reports, COA, supporting data for products shall be stored up to one year beyond the expiry of the product. Control sample records and logbook shall be stored 6 years from year end. Complaint forms and logbooks shall be retained for 6 years after closure of the logbooks. QC logbooks (e.g. Inward logbooks) shall be archived also for 6 years after closure of logbooks. Change Controls form and logbooks, Deviation forms and logbooks, OOS forms and logbooks, Rejection note, issuance, other logbooks and formats, etc. shall be retained for the period of 6 years from the closure the logs.

 Destruction Procedure documents

1. All documents shall be destructed after expiration of retention period. Destruction of the documents shall be completed within +1 month from the schedule destruction date as per attached list, Download Here 
2. Before destruction,approval from quality unit shall be taken and destruction shall be done in the presence of QA Representative and same shall be recorded in record for any product under dispute, the related documents shall not be disposed off unless and until the issue gets resolve.

• Master Copy: The original set of documents or written procedures, which shall be retained at Quality unit and shall always possess the stamp “MASTER COPY”
•  Controlled Copy: The photocopy of the master copy, which is distributed to the user department(s) as a part of document distribution procedure with a stamp“Controlled Copy”. These documents are retrievable.
•  Uncontrolled Copy: The photocopy of master copy, executed BMR/BPR, which shall be given to any external party for reference purpose only. These documents are not controlled documents; hence are not retrievable.
•  Reference Document: The photocopy of controlled document like executed deviation/ change control, which shall be given to any department for reference purpose only.
•  Raw Data: Combination of values- qualitative and quantifiable, which is required to processes to yield the desired information e.g. logbooks, formats, registers, data sheets, etc.
•  cGMP Document: Any document which is used for reading or recording of data which is directly or indirectly linked to the Quality Management System and to the product quality.