1. Documentation Evaluation & Reporting

2. First Step in Building an Effective System Is: To Have Good Documentation!

3. Definition Documentation: – defined as a system of records Essential to any quality system The foundation of quality

4. Documentation: The right amount Remember that the goal here is consistency for your processes. If two trained employees were to perform this task, would they do it the same way? If the answer to this is “ Maybe not ” a work instruction is appropriate.

5. Types of Documents Broadly classified into 3 categories: 1. Directive documents: – Tell personnel how to do something Examples: – SOP and other procedures – Information is NOT added to these documents when work is performed

6. 2. Data Collection documents: – Facilitate the recording of the data – Provide the evidence that a directive document has been properly followed – Examples: Reports, Lab books Forms Logbooks Types of Documents, contd.

7. 3. Commitments documents: – Lay out the organization’s goals, standards and its commitments – Example: Document submitted to FDA – NDA – New Drug Application Types of Documents, contin.

8. Why are documents so important? 1. Communication "How can I know what I think until I see what I say” 2.Cost 3. Audit trail Documentation

9. Why are documents so important? Cost of poor quality documents is hard to measure… But think of the time wasted through misinterpretation, recovering from errors, resubmitting to regulatory authorities, failing regulatory inspections… Audit trai l like footprints in the snow. Write what you do, do what you write and if you did not write what you did – you did not do it! Documentation - Cost

10. Documentation – General Principles General Principles – I Documents should be – designed – prepared – reviewed – distributed with care

11. General Principles – II Inspectors looks at the “Style” of the document – Instructions in the imperative Do, Stop, Mix, Blend, Wash, etc...... – Short sentences – Not long sentences Documentation

12. Documentation – General Principles III General Principles – III Approval of documentation – Approved, – signed and – dated by appropriate authorized persons – No document should be changed without authorization Any alternation should permit the reading of the original information Where appropriate the reason for the alternation should be recorded.

13. Documentation - IV General Principles – IV Distribution of documentation carefully controlled to ensure that up-to-date documents used – according to an SOP Electronically or photographically recorded data only by authorised persons. Older copies never deleted

14. Documentation - V General Principles – V Review – system for regular revision – master copies: date of the next review – Review (even if no changes are needed) should be documented – If changes, the change history attached If the document is a process record: (completely filled in legibly) – during the process (not later!) – by pen, no pecil (indelible!) If alteration: cross out and explain the alteration – no empty box should remain

15. Importance FDA policy: – “If it was not written down, it was not done” If the documentation relating to a particular batch of a particular drug/product is: – Lost – Accidently destroyed – Badly prepared THAT PRODUCT CANNOT BE SOLD Costing company $$$$$$$$........

16. Documents provide a record of: – what was done – when was it done – who did it – how and why Provide objective evidence that: – The product was made properly – All personnel followed proper procedures – All equipment used during the product manufacturing was operating correctly Importance, contd.

17. Documents: Main Functions 1. Record what an individual has done and observed 2. Establishes ownership for patent purposes 3. Tell workers how to perform a particular task 4. Establish the specifications by which to evaluate a process or the product 5. Demonstrates that a procedure was performed correctly

18. 6. Record operating parameters of a laboratory instrument or a manufacturing vessel 7. Demonstrate by an “evidence trail” that a product meets its requirement 8. Ensures traceability 9. Establishes a contract between a company and its consumers - thro’ written specifications and labels 10. Establishes a contract between a company and regulatory agencies Main Functions, contd.

19. Traceability According to ISO: – Traceability is the ability to trace the History Applications Location – of a product and its components Traceability helps to trace: – origin of the problem – May lead to recall of the product

20. Product & Documents Companies have extensive system in place to ensure that: Work is recorded Documents completed Documents securely stored Documents are retrievable Documents protected just as the product itself

21. Laboratory Notebook Type: Data Collection document Assigned to individuals Are a chronological log of everything that is done/observed by the individual in the lab – Notebooks and information recorded becomes the intellectual property of the company A legal document can be viewed by others Provide evidence for correct credit Shows the honesty and integrity of the data Can be subpoenaed in case of litigation

22. Guidelines: – Use only a well-bound notebook – Pages numbered consecutively – Enter the information in chronological order – Don’t keep the page blank - to enter the info late – Blank lines/unused portions should be crossed out with a diagonal line – Use indelible ink – Be legible, clear and complete Lab book may be reviewed by supervisor, colleagues, patent attorneys and/or regulatory inspectors Laboratory Notebook, contd.

23. Guidelines: – Cross out errors with a single line so that underlying test is clearly legible – Explain the reason of cross out, initila and date – Note all the problems. – Never erase or ignore a mistake – Date and sign each page – Store the notebook in secure location Laboratory Notebook - guidelines

24. Typical Components: – In the front: name of the person the book is assigned to – Date, title and description of the project – Results of any literature research – Rationale of each activity performed Document the idea – Any relevant calculations or equation Laboratory Notebook Typical Components

25. Typical Components: – Complete descriptions of lab equipment/instrumentation Including model & serial numbers – Chemicals/reagents used Catalog #, lot # & expiration dates – Sample assayed – Any standard or reference material used – Detail about the procedure used – Sample information Source, storage, disposal etc. Laboratory Notebook Typical components II

26. Typical Components: – Data Printouts from instruments Photos Authenticate the the data placement on the page – A brief summary of the work – Brief interpretation of the data Especially if this investigation is pursued on the basis of preliminary results Helps in any patent dispute, if any at a later date Laboratory Notebook Typical components III

27. Analyze Compare what you got and what you expected

28. SOP Standard Operating Procedure – A procedure is a written document – Has become standard Something good, correct, acceptable and established by authority, as a rule of measure of quality – It provides a step-by-step outline of how a task is to be performed

29. SOP – Things to Consider SOP says what to do, but not how to do it It may be written by someone who does not have experience doing the work SOP may have too little or too much detail May not have the order in which task is to be performed SOP may not have been updated Employees unable to find correct version/not trained on new version

30. Protocol & Procedure Protocol is procedure that tells an operator how to perform a task or an experiment – But is intended to answer a question or test a hypothesis Protocol can be a procedure but is performed only one time SOP is performed routinely – But DOES NOT lead to an answer to a question

31. Protocol & Procedure – Laminar Flow Example: Laminar Flow hood & Cleaning – A procedure is followed to clean a laminar air flow hood – A protocol is followed to investigate the effectiveness of cleaning the flow hood with different cleaning agents. A protocol must include: – What data to collect? – How to gather the data? – What proves or disapproves the hypothesis? – What statistics to be used?

32. SOP - Applying SOP says what to do, but not how to do it It may be written by someone who does not have experience doing the work SOP may have too little or too much detail May not have the order in which task is to be performed SOP may not have been updated Employees unable to find correct version/not trained on new version

33. Reports It is a document that describes the results of an executed protocol. It summarizes: – What was done – Who did it – Why was it done – What is the data – What are the conclusions Reports are written in narrative format R&D reports: published in scientific journals Manufacturing company reports: – Available for inspection – May or may not be published

34. Logbooks Used to record information chronologically about the: – Status – Maintenance of equipment or instruments Usually bound Associated with specific piece Entry made on each : – Use – Calibration – Maintenance – Repair

35. Labels To identify equipment Raw material Products Other items

36. Components of a Label Date of purchase of the item Person responsible for the item ID number of the item Lot number Identity/name/composition of the item Safety information Company’s name Storage and stability information

37. Batch Record Record of the details on formulation of a product, including raw materials required, critical steps, controls and required testing Batch record is a data collection document for the particular batch It is issued by Quality Assurance department It must be complete, readable and correct

38. Essential Components of a Batch Record 1. Product identification 2. Document identification 3. Company name 4. Dates of manufacturing 5. Critical steps and testing to be done 6. Process monitoring specs 7. Raw data to be collected, if any 8. Bill of materials 9. Equipment details, if any 10. Required signatures

39. Documentation: How to prepare culture media for sterility testing? Traceability & Document Pedigree Pagination Heading: purpose Instructions in imperative (action words) – Mix, weigh, or check, etc.

40. Electronic Documentation Records should be attributable to a particular individual Secure and safe from: – theft, disaster or access by wrong people Readily accessible Records should not be capable of being altered: – Accidentally – Intentionally

41. Ensuring Compliance Never Falsify Documentation Document After a procedure is performed Document only what You perform Record the Actual date Backdating is Never permitted Keep all originals – Never discard raw data

42. Final Product Records Final release document certifies: – That the product is within specifications – That the product documentation has been reviewed and approved – That the product is ready to be sold