Good documentation practice

This presentation is contain information about Documentation System of Pharmaceuticals. This presentation is prepared for training on documentation in Drug International Limited (Herbal Division) Depending on WHO and ICH guideline.

1. DOCUMENTATION M. S. K. Anwar Drug International Ltd. (Herbal Division)

2. HEADLINE Introduction Aims and Objectives Documents & Record to be maintained Observation on Poor Documentation Practice Good Documentation Practice (GDocP) 2

3. Introduction: “ IF YOU HAVE NOT DOCUMENTED ANACTIVITY, YOU HAVE NOT DONE IT ”. Document all the activities performed Do not perform the activity if it is not documented. As per GMP documentation control - “If it is not written down, then it did not happen”. Proverb: “  IF YOU HAVE NOT DOCUMENTED AN ACTIVITY, YOU HAVE NOT DONE IT ”. Proverb: “  IF YOU HAVE NOT DOCUMENTED AN ACTIVITY, YOU HAVE NOT DONE IT ”. 3

4. Introduction (cont..) Documents: An approved instruction either in paper or electronic form which guides about how an activity shell be executed. The document provides - Information on when, where who, why and how to complete the task. evidence proving that the tasks have been completed as they should be. Records: Records provide evidence that activities have been performed or result have been achieved. A record is often considered as document. They always document the past. 4

5. Aims and Objectives Compliance to regulatory requirement - No observation /warning letters / Import Alert / ban Build confidence on System & practice Correct, complete, current and consistent information Effectively meets customers and stakeholders' requirements. Ensure the traceability Useful for review, investigation & CAPA Solve complex problems Compliance to regulatory requirement - No observation / warning letters / Import Alert / ban Compliance to regulatory requirement - No observation / warning letters / Import Alert / ban 5

6. Aims and Objectives (Cont.…) Reduce or eliminate assumption and second-guessing Eliminate the need to re-ask the same questions Specify clear instructions to staff Consistent quality, yield and performance of staff. Provide background history (Information storage point for anyone to access. Information can be added at any time, providing a full history.) Preserves learning and knowledge (Reference for future use or a means to communicate information to others. Particularly important to ensure that knowledge is not lost when an employee leaves.) 6

7. Documents & Record to be maintained Batch Record Forms/BMR/BPR Bills of Materials (BOMs) Specifications Policies Protocols Standard Operating Procedures (SOPs) Work Instructions (WIs) Test Methods Checklists Forms/Log sheets Training Assessments Calibration Records Maintenance Records Non-conformance Change control 7

8. Documents & Record to be maintained (Cont.…) Electronic and hardcopy Quality records (e.g. non-conformance, corrective and preventative actions, internal inspection, change control, training records etc.) Certificate of Analyses (CoA) or Certificate of Compliance ( CoC ) Technical transfer reports Validation documentation Annual self inspection record CAPA (Corrective Action and Preventive Action) Clinical study record Complaints and Complaint handling/ monitoring Deviation Laboratory Notebooks/ Logbooks Labels (Product Labels/ Status Labels) Quality Management records 8

9. Observation on Poor Documentation Practice Missing signatures and dates at the time of activity performed. Non-uniform date and signature Activity was done & writing on one day and signed on another day. Blank spaces Illegible writing Too many corrections Write-overs, Multiple line-through "White-out" or other masking device Error correction not signed / dated, and reason for the correction not written Not traceable Data integrity 9

10. Observation on Poor Documentation Practice (Cont.…) Why do people sometimes fail to document activities or events properly? People do not clearly understand what or when to document. Procedures may not be completely understood or followed. People are not always held accountable. People will make mistakes. People don't always make corrections properly. People do not relate to auditing. People do not understand the legal role of documentation. 10

11. Good Documentation Practice (GDocP) Personnel should follow GDocP for both paper records and electronic records in order to assure data integrity. These principles require that documentation has the characteristics of being attributable, legible, contemporaneously recorded, original and accurate (sometimes referred to as ALCOA ). ALCOA-plus: A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”, which puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles. 11

12. Good Documentation Practice (GDocP) Attributable: Attributable means information is captured in the record so that it is uniquely identified as executed by the originator of the data (e.g. a person or a computer system). Legible, traceable and permanent: The terms legible and traceable and permanent refer to the requirements that data are readable, understandable, and allow a clear picture of the sequencing of steps or events in the record. Contemporaneous: Contemporaneous data are data recorded at the time they are generated or observed. Original: Original data include the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity. Accurate: The term “accurate” means data are correct, truthful, complete, valid and reliable. 12

13. Good Documentation Practice (GDocP) Documentation must be- Accurate: true / precise, error free, Concise: short & clear information that is understood by all Legible: shall be readable, understandable. Traceable: who recorded it, where, when and how Contemporaneous: Documented at the time activity done Enduring: Long lasting and durable Accessible: Easily available / retrievable Documentation must be; Accurate:  true / precise, error free, Concise:  short & clear information that is understood by all Legible:  shall be readable, undertanadable. Traceable:  who recorded it, where, when and how Contemporaneous:  Documented at the time activity done Enduring:  Long lasting and durable Accessible:  Easily available / retrievable 13

14. Good Documentation Practice (GDocP) Basic Principle Always record the entries at the time of activity simultaneously. Record data with the signature in GMP documents. Never sign for someone else on any document. Only sign for the work that you have performed yourself. A document with original signatures should never be destroyed. Use an indelible ballpoint pen to record data in GMP document. Never use a pencil or erasable or water-soluble ink pen to complete the GMP record. When one or more person complete the task, all person must sign. 14

15. Basic Principle (Cont.…) Never do white-out or correction fluid or cover-over-tapes to correct the entry in GMP records. No space, lines or fields are to be left blank Never falsify information and over-write a record. Never backdate GMP records. Never use symbols e.g. Ditto marks or arrows to indicate repetitive and consecutive entry. Never discard or destroyed any GMP record unless retention period expiry is reached. Good Documentation Practice (GDocP) 15

16. Record writing/ Data Entry Use a non-water soluble pen for writing on any official document. Use Ball point pens of blue or black colored inks to make entries. Don’t use pens like gel pens, ink pens for making entries. Don’t use pens like red, green color ink. Do not use pencil or ink that can be erased. Good Documentation Practice (GDocP) 16

17. Record writing/ Data Entry (Cont.…) Space and cells cannot be left “Blank” When spaces or cells do not contain information, Each must contain the appropriate “Not Applicable” entry Or N/A. Blank/Unused space in the GMP document should be strikeout with single line with sign and date to ensure that record cannot be added at a later date. This rule applies to all product-related documents - Electronic and written. Good Documentation Practice (GDocP) N/A Sign & Date 17

18. Record writing/ Data Entry (Cont.…) Never use ditto Never use lines (with or without arrows) to show a continuation of values or entries in a column or row Never mask the original entry. Never use Correction liquid, tape, or materials Good Documentation Practice (GDocP) 18

19. Record writing/ Data Entry (Cont.…) Correction of entry must be made properly Should not be overwritten or blocked to make it unreadable. (Don’t turn a “6” or “9” into an “8”.) Use a single strike outline to mark the incorrect entry in such a manner that entry remains readable, enter correct information above or to the side of the incorrect entry. Write initials and date of correction. Write justification if possible. When two people signed the original entry and then another changes the entry, the second person must also sign for the change. Good Documentation Practice (GDocP) 19

20. Record writing/ Data Entry (Cont.…) Illegible: Clearly Record the Data What’s that number? 27? 29? 24? 2% Hmmm. What do we do now? Suppose this is a final product, and the specification is 27 29 is acceptable. But what if it’s 24? Now what? We might have to reject the entire experiment and redo Good Documentation Practice (GDocP) 20

21. ICH-Q7: 6. Documentation and Record 6.1 Documentation System and Specification 6.10 All documents should be prepared, reviewed, approved and distributed according to written procedures. 6.11 The issuance, revision, superseding and withdrawal of all documents should be controlled with maintenance of revision histories. 6.12 A procedure should be established for retaining all appropriate documents until specified retention period. 6.13 All documents should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. 6.14 Corrections to entries should be dated and signed and leave the original entry still readable. 6.15 During the retention period, originals or copies of records should be readily available 6.16 Specifications, instructions, procedures, and records can be retained either as originals or as true copies. 6.17 Specifications should be established and documented for raw materials, intermediates where necessary, APIs, and labelling and packaging materials. 6.18 If electronic signatures are used on documents, they should be authenticated and secure. 21

22. 6.2 Equipment Cleaning and Use Record 6.20 Records of major equipment use, cleaning, sanitization and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance. 6.21 If equipment is dedicated to manufacturing one intermediate or API, then individual equipment records are not necessary if batches of the intermediate or API follow in traceable sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use can be part of the batch record or maintained separately. ICH-Q7: 6. Documentation and Record 22

23. 6.3 Records of Raw Materials, Intermediates, API Labelling and Packaging Materials 6.30 Records should be maintained including: Manufacturer Name, Identity and quantity of raw materials, intermediates or labelling and packaging materials for API's; the name of the supplier; the supplier's control number(s), if known, or other identification number; the number allocated on receipt; and the date of receipt; The results of any test or examination Records tracing the use of materials Documentation for conformity with established specifications; and The final decision regarding to rejected 6.31 Master (approved) labels should be maintained for comparison to issued labels. ICH-Q7: 6. Documentation and Record 23

24. 6.4 Master Production Instructions (Master Production and Control Records) 6.40 To ensure uniformity from batch to batch 6.41 Master production instructions should include: The name of the intermediate or API and an identifying document reference code, if applicable; A complete list of raw materials and intermediates designated by names or codes sufficiently specific to identify any special quality characteristics; An accurate statement of the quantity or ratio of each raw materials, Where the quantity is not fixed, the calculation for each batch size or rate of production should be included; The production location and major production equipment to be used; Detailed production instruction; Special notations and precautions to be followed; Instructions for storage, and special storage conditions with time limits; ICH-Q7: 6. Documentation and Record 24

25. 6.5 Batch Production Records (Batch Production and Control Records) 6.50 Should be prepared and include complete information relating to the production and control of each batch. should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction. 6.51 Record should be numbered with a unique batch or identification number, dated and signed when issued. 6.52 Documentation of completion of each significant step should include: Dates and, when appropriate, times; Identity of major equipment (e.g., reactors, driers, mills, etc.) used; Specific identification of each batch, including weights, measures, and batch numbers of raw materials, intermediates, or any reprocessed materials used during manufacturing; Actual results recorded for critical process parameters; Any sampling performed; ICH-Q7: 6. Documentation and Record 25

26. 6.5 Batch Production Records (Batch Production and Control Records) (Cont.….) Signatures of the persons performing and directly supervising or checking each critical step in the operation; In-process and laboratory test results; Actual yield at appropriate phases or times; Description of packaging and label for intermediate or API; Representative label of API or intermediate if made commercially available; Any deviation noted, its evaluation, investigation conducted (if appropriate) or reference to that investigation if stored separately; and Results of release testing. 6.53 Written procedures should be established and followed for investigating critical deviations or the failure of a batch to meet specifications. The investigation should extend to other batches that may have been associated with the specific failure or deviation. ICH-Q7: 6. Documentation and Record 26

27. 6.6 Laboratory Control Records 6.60 Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays, as follows: − A description of samples received for testing, − A statement of or reference to each test method used; − A statement of the weight or measure of sample used for each test − A complete record of all raw data generated during each test, − A record of all calculations performed in connection with the test, − A statement of the test results and how they compare with established acceptance criteria; − The signature of the person who performed each test and the date(s) − The date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. ICH-Q7: 6. Documentation and Record 27

28. 6.6 Laboratory Control Records (Cont.….) 6.61 Complete records should also be maintained for: − Any modifications to an established analytical method; − Periodic calibration of laboratory instruments, apparatus, gauges, and recording devices; − All stability testing performed on APIs; and − Out-of-specification (OOS) investigations. ICH-Q7: 6. Documentation and Record 28

29. 6.7 Batch Production Record Review 6.70 Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labelling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed. 6.71 Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before a batch is released or distributed. Production and laboratory control records of non-critical process steps can be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s). 6.72 All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released. 6.73 The quality unit(s) can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company. ICH-Q7: 6. Documentation and Record 29

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