Good documentation practice

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In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."

So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.

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Good documentation practice

  1. 1. GOOD DOCUMENTATION PRACTICE One of the way to be excellent… By : Hardik Mistry, Exe. Q.A. QUALITY SQUARE INDUSTRY
  2. 2. Good documentation constitutes an essential part of the Quality Assurance system. Schedule M : Good Manufacturing practices, 12 : Documentation and records EU GMP – Chapter 4: Documentation
  3. 3. Contents What is Good Documentation Practice (GDP) ? Purpose of Good Documentation Practices ? Standards of the GDP Types of the Documents Typical elements of the Document Common Documentation Errors How to acquire good documentation practice ? Benefits of the GDP
  4. 4. General philosophy of any Quality System Say What you do? Do what you say ? Prove what you say and do
  5. 5. What is Documentation ? To Document each Activity you performNo, Documentation is a Process, Which comprises of Following : - Recording of Data - Approval of Documents - Issuance and Disposal of Documents - Retrievability of Documents - Presentation of Documents - Review of Documents
  6. 6. Good Documentation practice GDP "Right-first-time“ approach for the document is GDP (to ensure identity, authenticity and accuracy of records.)If your Document says “What actions took place in the development or manufacturing of product so that anyone, including auditor or inspector has documented evidence that you did exactly what you said ” that is GDP.
  7. 7. Regulatory Requirements FDA Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section VI. Documentation and Records ICH Good Manufacturing Practice Guide for API Q7, Section 6 Documentation and Records 21CFR58 : Good laboratory practice, Subpart J. ISO 9001- 2008, Clause 4.2 : Documentation requirements Guide to GMP for Medicinal Products Part 1, Chapter 4 Documentation: PIC/S PE 009-8 (Part I)
  8. 8. The purpose of documentation Proof of fact Record Regulatory requirement Quality maintenance and improvement (Better risk management and robust quality systems) Control the processes (Resource optimization ) “Your documentation is an advertisement for your work” End User requirements To improve performance Enables important messages to be communicated clearly and accurately.
  9. 9. Why Documentation ? Cost for Good DocumentationCost for Poor/No Documentation
  10. 10. Documentation life cycle Document creation & Approval: - The process owner or the authorized person should write as per the specific format and template and circulate the document after getting approval of QA. Document use & Data collection: - Responsibility of all technicians, engineers, scientists, operating persons who are trained and authorized to collect and record data. Data Verification: - Responsibility of supervisors, managers and all individuals trained & authorized to review data. Record Review & Product disposition / Approval: - Responsibility of QA or those trained & authorized to review records
  11. 11. Cont…. Record Archiving:- Records are Accessible, Retrievable, Secure is the responsibility of QA & relevant departments Record Destruction: - As per SOPs that directs the destruction of documents
  12. 12. Who Participates in Creating the Documents?Everyone involved in the process or procedure Managers Team Leads Staff doing the work or impacted by the work Include ALL departments and divisions impacted Consultants may assist
  13. 13. WHEN ?  During implementation, all New Process or documentation is created and Procedure tested by all impacted departments  During implementation, all Change to an existing documentation is reviewed, Process or Procedure updated, and tested by all impacted departments  Annually, review all documentation to ensure it is accurate. Use as Periodic Review part of continuous process improvement cycle to evaluate need for change
  14. 14. Where documentation ? Documentation during Project Design, Documentation during Construction Phase, Documentation during Commissioning and start-up, Documentation during Qualification and Validations Documentation during Commercial Production, Documentation during Testing and Release, Documentation for Regulatory submissions. Documentation beyond…………
  15. 15. GDP standards Document creation Contemporaneous with the event they describe When electronically produced, the documentation must be checked for accuracy Free from errors For some types of data, the documentation must be in a format that permits trend evaluation Document approval Approved, signed, and dated by appropriate authorized personnel.
  16. 16. Document Signatures All documentation used to provide evidence that standards are being followed must be signed and dated by authorized person as it adds value to the document. Means of Signature  For the approval  Authorized person involved in it No signature pads, scanned signatures, or duplicated original signatures shall be used to replace a handwritten signature by the person signing. Documents shall be signed in permanent ink. Signatures shall be kept throughout the life of the document. The local date shall be used to date documents.
  17. 17. Handwritten entries Adequate space is provided for expected handwritten entries Handwritten entries are in indelible ink Critical entries must be independently checked (SPV, or second person verified) No spaces for handwritten entries are left blank - if unused, they are crossed out or "N/A" (or similar text) entered Ditto marks or continuation lines are not acceptable A stamp in lieu of a handwritten signature is not acceptable
  18. 18. Document maintenance Regularly reviewed and kept current Record for the creating, issuing and modification should be there Retained and available for appropriate duration & in appropriate condition Electronic document management systems are validated Electronic records are backed up
  19. 19. Document modification Handwritten modifications are signed and dated Where appropriate, the reason for alteration must be noted ("E.E." is a common abbreviated reason, indicating "Entry Error") Controls exist to prevent the inadvertent use of superseded documents Electronic versions can only be modified by authorized personnel and controlled by password or other means A history must be maintained of changes and deletions to electronic versions as well as paper documents. Uncontrolled changes can have a substantial impact on a company‟s ability to demonstrate compliance to their specific standards. Reference : Document Creation and Change Request form. HQR - 423 -01.
  20. 20. Corrections/Additions1. In Record Single line through the information that needs to be corrected. All corrections or additions shall be signed and dated. Should not to scribble out the original data, use white out or write over data .2. In Document Only personnel who have already been approved to write or make changes to document can correct or add to documents. Non-typographical error corrections or additions indicating a change in data or acceptance status require a comment. And routed through full document Change control. Typographical error change or additions do not require approval. Reference : Document Creation and Change Request form. HQR - 423 -01.
  21. 21. Document review Responsibility of supervisors, managers and all individuals trained & authorized to review documents and data at specific time interval. An approved list of designees, originators, and reviewers shall be maintained. Designees If a designee is to be used, then that person signs his/her name, adds the words “signing for,” and adds the original printed name of the approver. Designees must have the knowledge, skills, and abilities to perform the assigned authorship, verification, or approval activity.
  22. 22. Document retention time and responsible person
  23. 23. Review of the quality related documents
  24. 24. Types of the Documents Commitment Documents : Relationship between industry and the regulatory authorities Exa : NDA, SMF Directive Documents : Relationship between the Management and Employees Exa : Specifications, STPs, SOPs, MFRs etc. Record Documents : Relationship between the Employees and the Work they perform Exa : Protocols, BMRs, Log Books, Calibration Records etc.
  25. 25. Copy of the Documents Clear, legible Errors should not introduced during copying No any copy is allowed unless if it is stamped particularly Master Copy Original copy of the document Controlled Copy The copy of the document from master copy and used in regulated environment signed and stamped by qualified person. Uncontrolled copy The copy of the document from master copy, made for information purpose only. Superseded copy Old version of the copy which is replaced by the latest version of the document Obsolete copy Copy of the document which is to be discontinued
  26. 26. GMP DOCUMENTS Specifications Standards Tests on identity, content, purity and quality for starting and packaging materials Pharmacopoeias, reference standards, and Specifications for intermediate, finished, and other reference materials should be available bulk products. in the quality control laboratory. Specifications for water, solvents and reagents (e.g. acids and bases) used in production. Master formula Record Packaging instruction BMR BPR Records should be maintained of the A batch packaging record should be kept for distribution of each batch of a product in each batch or part batch processed. order to facilitate the recall of the batch if necessary. Line clearance Analytical RecordsBefore any processing begins, a check should be Analysis records, the tests performed should made and recorded. (That the equipment is be recorded clean and work station are clear of previous products, documents, or materials not required for the planned process) Equipment Records Records should be kept for major and critical equipment of any Validations and CalibrationsMaintenance and repair operations and cleaning
  27. 27. Cont…. Standard operating procedures Equipment assembly and validation Analytical apparatus and calibration Maintenance, cleaning, and sanitization Personnel matters including qualification, training, and hygiene Environmental monitoring Pest control and assigning responsibility for cleaning and sanitation Complaints, Recalls, Returns and Sampling For testing materials and products at different stages of manufacture describing the methods and equipment to be used. For the internal labelling, quarantine and storage of starting materials, packaging materials and other materials For the receipt of each delivery of starting material and printed packaging material.
  28. 28. Typical elements of a documentation system Logo Title Doc. no Effective date Revision Page no Signature Format Stamp
  29. 29. Document Numbering All document shall have a unique document number. This is typically issued by a document control department or person (Quality Assurance).
  30. 30. Date & Time A legal date is comprised of a month, day, and year, although not necessarily in that order. Local conventions are assumed unless otherwise specified in an SOP. It should be in uniform format. For example : DD/MM/YY or DD/MM/YYYY Postdating (entering a date of the future) is not permitted Backdating (entering a date on a day after the entry was made or the task was performed) is not permitted If times are required, procedures identifying approved guidelines for documenting date and time (AM/PM or 24 hr) shall be defined.
  31. 31. Document Effective Date Date of the change or the date from which the document become live. Effective date changes on every new change in the document. And each change should be recorded at change history at the front page of the document Document Review Date Date given to the document after the respective departmental head review the document in consultation with actual user. And after approval all the master and controlled copies are stamped as “REVIEWED” on the document with review and next review date.
  32. 32. Document Review Document review will focus on the document‟s content, context, format and grammar. The document quality attributes of concern document review are correctness, usability, appropriateness and maintainability. Review factors and criteria are :  Adherence to standards  Consistency and traceability  Readability, comprehensibility, and general understandability  Technical adequacy and feasibility of approach  Degree of completeness  Testability of requirements  Use of appropriate requirement, design, or coding techniques  Appropriate level of details Reference : http://www.wildfire.gov/pmu/pmo-rchive/products/documents/Review_Guidelines.pdf
  33. 33. Document Revision All documents shall have a revision level & latest document should live. Two type of the revision 1. Routine revision : - No technical or editorial modification but at the end of the two years of the effective date. - HOD will review and if there is no any change then HOD shall send internal communication that this document doesn‟t need revision. - If yes then Review the document and stamped as “REVIEWED” - Valid only twice then document is revised as per DCC procedure. 2.Technical or editorial revision : This type of the revision shall be carried out by Document change control procedure and recorded. Every piece of a document shall be marked with the page number as well as the total number of pages in the documents. X of Y.
  34. 34. Signature & Date Document which doesn‟t has sign and date of the approval consider as the incomplete document. All documents shall be signed by the originator. No signature pads, scanned signatures, or duplicated original signatures shall be used to replace a handwritten signature by the person signing. Documents shall be signed in permanent ink. Signatures shall be kept throughout the life of the document. The local date shall be used to date documents.
  35. 35. Common Documentation Error Missing signature and dates at the time the activity is performed. The “write over” and the “scribbler”. Non uniform date and signature entry. Data entries that do not correspond to the batch record instructions. Writing a note that activity was performed on one day and signed for on other day. Blanks on batch production records. Pre-recording of data. Incomplete references. Review not signed. Illegible writing. Too many corrections.
  36. 36. Common Documentation error
  37. 37. How to acquire GD practice ? FDA statement should drilled into you from day one „If you didnt document it, then it didnt happen„‟. On one hand do the work, On other make the document Use indelible (water-resistant) blue or black ink Never use White ink to remove error Do not use pencil or felt-tipped marker Never overwrite or Scribbled the entry. Just single cut the error with sign and date. Never leave space or blank in the document and Draw a diagonal line through any blank fields or empty spaces at the bottom of a page and include N/A along with your initials and date.
  38. 38. Cont…. NEVER back date, NEVER post date and date in uniform format Each page in a controlled notebook chronologically. When entering repetitive data, do not use ditto marks. For instrument printouts, adhere with clear adhesive tape and include your signature and date where the printout is attached. Signature logs must be maintained, indicating each employees printed name, signature and date. We should forget the syndrome “We can fix the documentation later .......”. Reference : HQR - 423 - 02 Employee Signature Form
  39. 39. Benefits of good documentation Unlock the potential of individual using the document Amplify the value of your product Build confidence in your quality Good Documentation helps to save the papers Reduce the efforts to compliance with regulatory bodies Good documentation enables to achieve the results that you are seeking for.

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