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PROCEDURE FOR DOCUMENT & DATA CONTROL (Part II)

PROCEDURE FOR DOCUMENT & DATA CONTROL (Part II). TABLE OF CONTENTS. Procedure for Document & Data Control. 1. PURPOSE 2. SCOPE 3 . RESPONSIBILITIES & AUTHORITIES 4 . REFERENCE 5. PROCEDURE 6. DOCUMENTS / RECORDS . PROCEDURE FOR DOCUMENT & DAT CONTROL .

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PROCEDURE FOR DOCUMENT & DATA CONTROL (Part II)

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  1. PROCEDURE FOR DOCUMENT & DATA CONTROL (Part II)

  2. TABLE OF CONTENTS Procedure for Document & Data Control 1. PURPOSE 2. SCOPE 3. RESPONSIBILITIES & AUTHORITIES 4. REFERENCE 5. PROCEDURE 6. DOCUMENTS / RECORDS

  3. PROCEDURE FOR DOCUMENT & DAT CONTROL • 1. PURPOSE • To establish a procedure to: • -Allow review, update and approval of documents prior to use. • -Ensure that relevant versions of the documents are available at all locations essential to the functioning of the Quality Management System. • -Provide control over obsolete documents to prevent unintended use.

  4. PROCEDURE FOR DOCUMENT & DATA CONTROL • -To identify and control any relevant documents of external origin, • e.g. National standards or client contracts & drawings. • -Provide control of records. • -Provide control of notices and other temporary sources of data including hand-written information. • -Establish a process for computer back-up.

  5. Procedure for Document & Data Control 2. SCOPE • This procedure is applicable to all Sections/ Departments as per GMP guide line that defines clearly.

  6. Procedure for Document & Data Control 3. RESPONSIBILITIES & AUTHORITIES Head of the Plant • Head of Quality Assurance • Head of Production • Head of Quality Control • Head of HR/Admin. • Head of Purchasing • Head of Regulatory • Head of Marketing • Document Control Section

  7. 4. REFERENCE Procedure for Document & Data Control Any GMP Guide line like WHO. European, Japan, Australian, ISO-9001-2008 etc. Do not for get to take guide line from DRAP

  8. Procedure for Document & Data Control 5. PROCEDURE 5.1 Document Control Section: • The Document Control Section should be established to authorize any Request for Approval of Documentswhich is headed by any technical personnel who is qualified & has vast practical knowledge. b. Document Management Committeeis established to review the Document for its approval & then to issue control no. .

  9. PROCEDURE FOR DOCUMENT & DATA CONTROL • The Document Management committee consists of Senior most experienced person who heads this committee. • The other members are -Concern Departmental Head -Manager QA or Manager QC

  10. PROCEDURE FOR DOCUMENT & DATA CONTROL • The controlled documents (Procedures, Specifications, SOPs, Records, instruction etc.) should be available in the Computer of Document Control Section as soft copy and one set of Hard Copy as well for reference.

  11. PROCEDURE FOR DOCUMENT & DATA CONTROL 5. PROCEDURE CTerminals for Documents Access • A List of Identified Terminals for access of document should be developed.

  12. PROCEDURE FOR DOCUMENT & DATA CONTROL 6.2 Generation/Change/Deletion of Documents: a. Documents are controlled and electronically maintained by Document Control Section. b. The concern Departmental Head prepares Draft, initiates Request for Approval of Documentswith the entry in Document Generation/Change/Deletion Request Log and forwards to the document control section.

  13. PROCEDURE FOR DOCUMENT & DATA CONTROL • c. Document Control Section enters it in PreApproved Document Receiving Logand forwards to the Committee for its approval.

  14. Procedure for Document & Data Control 6. PROCEDURE 6.3 Preparation, Review, Check and Approval: -After review, check and approval of documents, Document Control Section assigns a Document Number and notes down the required information in the Master List of Controlled Documents. -Controlled Documents are reviewed at least once a year or any time if any change is required.

  15. PROCEDURE FOR DOCUMENT & DATA CONTROL 6.4 Syntax of Document Number: Table - I Nature of DocumentSyntax • Quality Manual NO-QM-00 • Quality Management Procedures NO-QMP-00 • General Sop for Department NO-D-Sop-G-00

  16. Procedure for Document & Data Control 6. PROCEDURE Nature of Document Syntax Machinery/Equipment NO- D- ME-Sop-00 Sop for Measuring & NO-D-Sop-MTE-00 Test Equipment

  17. Procedure for Document & Data Control 6. PROCEDURE

  18. PROCEDURE FOR DOCUMENT & DATA CONTROL • Nature of DocumentSyntax • Log NO-D-LG-00 • Formats NO-D-F-00 • Lists NO-D-LT-00 • Equip. Qualification Protocol & Report NO-QA-MEQ-PR-00 • Process Validation Protocol & Report NO-QA-PV-PR-00 • Cleaning Validation Protocol & Report NO-QA-CV-PR-00 • Analytical Method Validation NO-QA-AMV-PR-00 • Job Description NO-HRA-D-JD-00

  19. Procedure for Document & Data Control 6. PROCEDURE 6.5 Preparation, Checking and Approval of Documents: Table II

  20. PROCEDURE FOR DOCUMENT & DATA CONTROL 1. Approval of JDs(Officers/Supervisors/Operators/workers) Manager HR/Admin. MQA Plant Manager 2. Job Description (Managers ) Manager HR/Admin. Plant Manager Director 3. Job Description for (Plant Manager) Manager HR/Admin. Director Chief Executive

  21. PROCEDURE FOR DOCUMENT & DATA CONTROL 6.6Document Control Block: a Document Control Block should appear on the top of each page of the document to control the issuance and validity of the documents.

  22. Procedure for Document & Data Control 6. PROCEDURE • The details of the Document Control Block shown below is applicable to all the pages of the documents:

  23. PROCEDURE FOR DOCUMENT & DATA CONTROL 6.7Master List of Controlled Documents: a. Master List of Controlled Document identifies Document number, Document Title, the current revision status of document and controls updated issue status, page status, hard copy, distribution & recall.

  24. Procedure for Document & Data Control 6. PROCEDURE 6.8 Documents Distribution: a. Provision for distribution of Hard Copy of Controlled Document is established through Document Distribution form. b. Document Distribution System is described in the Master List of Controlled Documents.

  25. PROCEDURE FOR DOCUMENT & DATA CONTROL 6.9 Document Recall: a. There should be provision set for recall of Hard Copy of all the obsolete Documents except Document Control Section. Obsolete Documents are taken back through “Obsolete Document Re-call Form”. b. Document recall System is described in the Master List of Controlled Documents

  26. 6.10 Handling of Obsolete Documents a. The Document Control Section marks copy of the OBSOLETE document and its particulars are noted down in the List of Obsolete/Changed/Deleted Documentsand keeps it as record. b. The Documents of External Origin are identified and there distribution is controlled. (List of Official Books)

  27. Procedure for Document & Data Control 6. PROCEDURE 6.11 Uncontrolled Copies: a. Documents may be used/ issued to personnel and outside parties for information only are stamped with the words “UN-CONTROLLED COPY” on the title page. These Uncontrolled documents may also be issued to personnel who manage, perform or otherwise control activities.

  28. Procedure for Document & Data Control 7. DOCUMENTS / RECORDS 7.1 Request for Approval of Documents 7.2 Document Generation/Change/Deletion Log 7.3 Pre-Approved Document Receiving Log 7.4 Master List of Controlled Documents 7.5 List of Identified Terminals for Documents Access 7.6 Document Distribution Form 7.7 Obsolete Document Re-Call Form 7.8 List of Obsolete/Changed/Deleted Documents

  29. Thank you very much

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