a : » 10/40" EY Macleods Centre of Excellence Technical Training [Title \ le [Good Documentation Practices Document MCENwi007-00 | 7-00 Effective Date: #| ae ate Reviewed by (08) acleods Centre of Excellence . Technical Training or cre SS Good Documentation Practices \ mcesrt1707-00| L—jon Practices mentation Good Docu! Index «Objective Documentation concept & its importance ‘Scope of Good Documentation Practices Good Documentation Practices in Completing documents Good Documentation Practices for Document Managetaent ‘Commonly encountered documentation errors McE/T#/007-00 300d Documentation Practices tas ca ee —— Document Material that provides official infor record. Itis tegul requirement to generate, m: activity/tasi/operation/tes It may Le hand written, intain documents 2 aa evidence OF d out during day to cay works in the form of soft copy: Records Culleetion of Real Time Data... -Unehangeable, Decament containing complete eT ——. ation or evidence ur that serves a8 # any10/10/: Good Documentation Prac es —e—————————————— Good Documentation Practices Comments and clarifications being written should be FACTUAL, CONCISE & TRACEABLE! Be Factual - State facts, Not supposition Concise - Be descriptive yet brief ‘Traceable - Easily tracked within the document orto related records. MCE/TH/007-00 @O Macecde Cn of xollence Tacs sii ee Documentation concept & its importance > Adocument system is an interacting set of documents, each with a defined purpose and consistent approach. Purpose of Documentation: ¥ Assure that q standards are consistently met ¥ Communicate these standards to all who interact with product V- They are used to define specifications for materials and for methods of manufacture and contre! They ensure thet everyone concerned with manufacture and QC knows what to wcerryo07-00_ ation pinion tina Good Document ept & its importance Documenta ‘They allow decisions to be taken on batch release, Y They allow it ticularly important in the case of dit trail, which is pa Y_ They provide an aus suspect batches documented evidence, traceability, provide records and audit tral for v Ensures investigation Ensures availability of data for validation, review and statistical analysis, Ensu G ood Documentation Practices _ ee ene a Importance of Good .Documentation ences that we bave % Documentation is an integral part of GMP and are evidences that performed the activity in a syswematic & standard manner. ~ Clearly written documentation prevents errors, % Good Documentation ensures the ad evidences tence of documented vid traceability and provides records that allow investigations. get ; fi in order t0 8 * {Ls important for a manutaciurer to yet te documer fon right in order the product risia, ue ‘aaionns me 2072 Le ——____ @ _— eee10/401, Good Documentation Practices Remember... Df it wasn't documented correctly, ie sis wasn't done ! DIt it can't be understood, wo. it wasn’t documented!! ‘McesTH007-00 © omni ot Be Scope of Good sd Documentation Practices © Good Documentation Practices are applicable to the following: Y Preparation of Documents Completing / Filling documents “Archiving & storing of documents Review document for erors~ critical erors ein units, specification et, ate not acceptable v as nied & date by appropriate /authorized persons Document should be approved, No changes should be made to approved documents without authorization _ mce/T¥/007-00 O18 Morleods Centre of ExcellenceGood Documentation rracnees Think.... before you document !! Even though the pace in our industry is fast but everyone deserves the time to think things through... be sure that you have understood & written correctly!! Mce/TM/007-00 Macieods Cente of Excellence Good Documentation Practices General instructions for Good Documentat > Date, month and year shall be wriiten in the format Day-Month-Year or Day / Month / Year, wherever applicable (use 2 digits for DD/MM/YY).For year use last 2 digits from RHS like 2018 write 18 Deg, Date : Use 2 digit for D/M'Y i.e. O1/01/1J of 01/01/2011 > — Time shall be recorded in 24 hot ur clock format. Os eg. 10:30 AM as 10:30 hrs & 4:15 PM as 16:15 hrs. | Do not write AM/PM with 24 Hr format ow mark shall be put ior activities which are veritied, wherever applicable, e.g, in-check box. “ @) Macteods Contre of Excellence10/101. —THAcI=oa5] Good Documentation Practices Ea) General instruetio for Good Documentation For data in decimal format where the number is less than one, place zero before the _Arrowing down or across to indicate correct data is not permitted, ce A 20 x< B 2.5 | ‘Ncerrsv007-00 & Meseciscanvetevcaence | | Good Documentation Practices ‘General instructions for Good Documentation > Always fill in the blanks !! > Record all requested information, Do not keep it blank. > [fit’s truly not applicable, Write 'N/A' with your initials & date. them & write 'N/A' with your initials & date, Wherever required state the reasons. > The correct information must be entered on batch records, equi Jogbooks, test result forms, reports etc, other eetal auditor. se you will be caught by sr = veer @ Veinch Chea oo > Ifpages or sections of forms are not applicable, Line through |ATE: ‘Minn Ge the appropriate format! > Record data directly > Do not write original data on serap paper, hand or paper towels and then transfer to format or note book. > Always attach printouts and labels where indicated. > Never throw away original data, } Use additional page or sheet when more space is needed, giving appropriate identification number, > Finally original information or data should not be lost & McE/Tm/007-00 @® Macleods Centre of Sxcallanca Good Documentation Practices eee ce General instructions for Good Documentation Always write clearly & legibly Remeber. ‘The information you write will bx reviewed / used by another person. ‘@ie/she should be able to understand what you have written, otherwise it will lead to errors, ‘© Critical errors can lead io batch reje i a L icermoo7-o010/10). ——_—___ Good Documentation Practices Food Documentation ‘When affixing supporting documentation to a page, special care may be needed. Otitis on sensitive paper Oi ithas to be folded to fit the page thas more than a single sheet What should you do? Use a binder or folder Do not use staples or paper clips in manufacturing area. xDo not use tape or glue that dries out easily etecos Cente of Evcatlencs McE/T™/007-00 @ | ~ Raa [Good Documentation Practices On-l “practice to do on-line documentation, Record results as you get them! * {GMP error isto spe through the documents atthe end ofthe day or at sane fake sit iting inal the blanks records a one time ive minutes ago, much impossible to remember what we did five minutes ago, mucl But we all know at its impos jould be recorded and traceable (time, operator, equipment used d Macteods Cente of Excelence cermayoo7-00| | | L Good Documentation Practices Good Documentation Practices All documentation errors require corrections! + Corrections thust be legible, Never cross obliterate an entry by use of ‘correction tape or white fluid. + Use asterisk or circled number to identify the error correction to item being, corrected. * Write the reason for correction as close to the error as possible. * The incorrect entry must be vi L “weerrw7e07-00 & Maccods Cente of Excalence Correcting Errors _ _ Suk te ery wih | ha single line such Tat te paetoos ou | | | irre eniy 's legible and canbe ead cierly even al : early even as itis stuck ot Ener the eorect entry beside the stuck off incurs ety ‘ign with date and rite the reason in bie omplete paragraph ora page lll oftet ina” | Sulke ts coopiae Co — = sel register is to be correct a trike the complete vith a diagonal tine and enter the gtr ob erected entered) sey Become papa oth eee | Sig wih dt and ke te tee of 7 - whee eaestdats ote eneed ee sig Ey | Nake cen u Sig wis a wy mal Give reasons in brief fir missing entry, ° | Teetence ofthis. ae no / | i ‘MCE/TW/007-00 ? @) ae Maceods Cente of Excelence