DOCUMENT AND DATA CONTROL

Definitions Documents - Controlled Quality documents like BMR, SOPs, Specifications & STPs/ GTPs, Protocols, etc. Master Copy - The original set of controlled documents or written procedures which shall be retained at Documentation Cell of Quality Assurance and shall always possess the stamp ‘MASTER COPY’ on the front side of every page. Controlled Copy - The photocopy of the master copy of controlled documents (like SOPs, STPs, GTPs etc.) or written procedures which shall be distributed to the user department(s). Uncontrolled Copy - The photocopy of master copy of controlled documents or written procedures which shall be given to any department or person for reference purpose only.

Generation of the document User shall prepare documents or make data entry in records by considering following points: Be sensitive to GMP compliance. Record activity immediately but correctly. Check entry of records for accuracy. Sign and date immediately on record. Check if deviation exists. Don’t destroy record/ evidence in case of deviation or OOS. Co-operation during investigation.

Generation of the document Checker/ Reviewer shall check/ review the documents by considering following points: Verify record for adequacy/ accuracy. Check technique/ skill of user periodically. Sign and date for review. Report investigation, deviation, incident etc. promptly. Advise how to rectify/ correct the error in data entry. Guide user in technique & skill.

Generation of the document Approver shall approve the document by considering following points: Verify adequacy/ accuracy/ sensitivity of document. Verify against guidelines/ regular standards/ SOPs/ Pharmacopoeia. Sign and date on approval of document. Guide / Assist in investigation.

Generation of the document Master copy shall be an approved original copy of documents and shall be prepared by stamping of “MASTER COPY” stamp in “Green color” on each page of the document at right side of top corner position without obscuring any text. Controlled copy shall be prepared by photocopy of master copy with stamping of “CONTROLLED COPY” stamp in “blue colour”, QA personnel shall write copy no. with sign& date on each page of the document at bottom right side position without obscuring any text. Uncontrolled copy shall be prepared by photocopy of master copy with stamping of "UNCONTROLLED COPY" in "red colour" and signed / dated by QA on each page of the document at center on the text matter.

Issuance & Control of Documents All documents including validation documents like validation protocols/ reports, qualification documents, etc. shall be under the control of Documentation Cell of Quality Assurance department. Documents like SMF, VMP, Quality Policy and Quality Manual shall be kept at the Documentation Cell of QA. All the Calibration data of equipment / instruments shall be kept / maintained by the QA department .

Issuance & Control of Documents All the data maintained in laboratory software / production PLCs shall be password protected. A printed hard copy of analytical & processing data, duly signed by operator shall be preserved along with the respective documents . Backup data shall be taken on the compact discs or space access given by IT personnel by time to time. All rubber stamps shall be kept under Lock and Key, along with updated list of stamps.

Issuance & Control of Documents Issuance of all the controlled document shall be governed by QA documentation cell. For issuance of any type of controlled document, user shall fill the issuance form.

Review and/or Revision of the Documents Revision procedure of documents shall be of two type: Routine or periodic revision Provisional or conditional revision All the controlled documents shall be reviewed within one month before and after the ‘Review Date’ assigned on the concerned document. If there is a need of any change in a document, the revision shall be initiated by only “change control form” as given in the SOP on change control.

Review and/or Revision of the Documents QA shall intimate the initiator department to initiate review process Initiator department shall undertake the review Initiator department shall forward the Document Review Form with comments to QA On receipt of the final comment from the concerned dept, QA shall dispose the review process. Quality Assurance shall assess the proposed changes. If OK, approved. QA shall forward the approved draft copy to initiator department to prepare a final soft copy of document. By incorporating all comments on soft copy, initiator shall forward it to QA. Initiator shall delete the same from his/her computer and E-mail. QA shall take out the final print out. Revised copy of document shall be signed by concerned persons, approved by Q.A. Head.

Distribution and Retrieval of the Documents All the controlled documents shall be distributed and retrieved by Documentation Cell of QA. Distribution and retrieval of the concerned document shall be done using the specially prepared form titled ‘Document Distribution and Retrieval Record’. Additional controlled and / or uncontrolled copies of the documents, if required, shall be requested through a form titled ‘Requisition for Additional copy’. The retrieved controlled copies of the document shall be destroyed by Documentation Cell of QA.

Archiving of Documents Arrangement of all the documents shall be with respective department wise that can be identity and easily traceable. All the batch records received should be reviewed and then store in designated area according to the Batch No. The master copy of superseded document shall be retained by the Q.A. and stamped as “OBSOLETE” in center of document on every page.

Retention of documents Type of Document Retention Period Method of Destruction 1 Cleaning and maintenance documents After one year of product expiry Shredding 2 Calibration record 3 years 3 Packaging material record 4 Batch Manufacturing record 5 Qualification record Permanent Not to be destroyed 6 Validation record 7 Cleaning Validation record 8 Water system Validation record

Retention of documents Type of Document Retention Period Method of Destruction 9 Media fill record Permanent Not to be destroyed 10 Method Validation record 11 Validation master plan 12 Site Master File 13 Master formula record 14 Vendor audit report 15 Department manuals 16 Standard operating procedures 10 year 17 Training record 1 Year after resignation of employee Shredding 18 Internal audit record 5 years 19 Medical records 1 Year after resignation of employee

Retention of documents Type of Document Retention Period Method of Destruction 20 Controlled copies of Master Documents Destruction on retrieval Shredding 21 Stability Data Permanent Not to be destroyed 22 Organogram 23 Specification, STP, GTPs 24 Facility layouts 25 Filled formats & records 5 years

Handling of Records Each concerned department shall be responsible to fill all the records relevant to the approved written procedures. The documented data or records shall be forwarded to Documentation Cell of QA at appropriate intervals. Documentation Cell of QA shall prepare a department wise list of records.

Destruction of Documents and Records Retrieved controlled copies of superseded documents shall be destroyed by Documentation Cell of QA using paper shredder machine or manually or through incineration and the relevant recording shall be done. Incharge, Documentation Cell of QA or his/ her designee shall record the details of destruction of obsolete master copies/ documents in ‘Documents/Data Destruction Record’

Handling of External Origin Documents External origin documents such as pharmacopeias, books, reference guideline etc. shall be issued, retrieved and controlled by QA. Issuance record of these documents shall be maintained by QA. In case new versions of these documents shall be published then QA shall procure these new versions of documents. QA personnel shall retrieved the old version of these documents.

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