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Importance of documentation for gmp compliance


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    can you provide the referrence for the last finding listed on slide 62, the use of emails for product decisions,

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  • 1. Importance of Documentation in GMP compliance By: J.Ramniwas Director-Regulatory and Quality Affairs Pharmaocean,Vadodara(India) 1
  • 2. Objective• To review general requirements for documents• To review specific requirements for each document• To give general guidance how to create good documentation system •A reliable evidence for GMP compliance. •Quality by design is the only solution to overcome the quality-related complaints in an organisation. •An essential element of quality assurance is good documentation practices. •The system of documentation devised or adopted should have as its main objective to establish, monitor, and record “quality” for all aspects of the production, quality control and quality assurance 2
  • 3. Purpose of DocumentationClearly written documentation prevents errors that may arise in oral or casually written communicationIt provides assurance that quality related activities are carried outexactly the way they have been planned and approvedThe achievement of conformity and quality improvementPurpose of documentation : To ensure that there are specifications for all materials and m ethods of manufacture and control Employees know what to do Responsibilities and authorities are identified Ensure that authorized persons have all information necessary for release Provide audit trail Forms the basis for improvement. 3
  • 4. Quality Based Documentation SystemCorporate Communication tool – internal and externalIntegral part of corporate interactionsCorporate Policies – Rationale for responsible decision makingCurrency of corporation 4
  • 5. Quality Policy and its ImportanceManagement commitment to quality•Customer FocusedSatisfy our customers needs and expectations•Make commitments we fully understand and believe we can meet•Meet all commitments to customers on timePerformance Driven1. Verify that our products and services meet agreed requirements2.Monitor, benchmark and continuously improve our business, products and services, organization and employees performanceAchieve Organisations Mission and Goals1. Sustain and develop business growth and Intellectual Property 5
  • 6. Quality ManualThe strategic document that outlines the organization’s system ofproviding quality assurance to achieve customer satisfaction Objectives : Describe the quality system structure Declare the quality policy and organization goal Describe how the organization meets the quality goal Content of quality manual : The quality policy declaration The goal of quality; The organisational structure including responsibility and aut hority of each key personnel Procedures, instructions and resources for implementing the quality management. User : All personnel in the organization Another parties, auditors, and customers 6
  • 7. Design of DocumentsUsefulFlexibleGrowChange 7
  • 8. Type of GMP Documents1. Description Documents• Describe how to perform certain tasks• E.g.. SOPs, Protocols, Specifications, Master Production Records etc.2. Data Collection Documents• Facilitate the timely and accurate documentation of tasks and events• E.g. Forms, Reports, Production Batch Records , Logbooks etc.3. Numbering Systems• Serves to account for and track information and documents• E.g. Lot numbers, Part numbers, equipment numbers, Form numbers, SOP numbers, Receiving codes etc.4. Data Files• Serves to organize the data in to useful categories for review and to support accountability and traceability requirements• E.g. Specification Files, Equipment Files, Equipment history files, Product files, Facility Qualification files etc. J.Ramniwas 8
  • 9. Function of GMP Documents• Establish, monitor and document Quality1. Description Documents Define and establish the Quality of Raw materials, environment, production process and Finished Product2. Data Collection Documents Confirm the materials ,environment , production processes or product routinely meet the established Quality characteristics.3. Numbering Systems Control and track the use of descriptive documents and data collection documents4. Data Files Organize the data in to useful categories to facilitate review and retrieval 9
  • 10. Users1. Bottom –up• Manufacturing, Laboratory or Operational personnel who interact with the detailed steps of the system on a daily basis• Need to know what to do and how to do it2. Top-Down• Administrative personnel e.g. management, regulatory, development, finance, marketing who must understand and interact with the system by reference• A good document is written both to inform and to educate• It must meet the needs of the line workers and the administrators E.g. SOP on specification writing- describes the purpose of specifications, provide guidance on the decision making associated with writing specifications, numbering systems, change controls and responsible personnel, steps on generating and approving an SOP etc. 10
  • 11. A Well Designed Documentation SystemEnsure Quality standards are met routinelyMinimize the potential for ErrorReduce downtime when deviations or failures occur by providingimmediate access to well organized dataServe as a consistent training tool for line workers and administratorsGMP documents should be prepared, reviewed, approved, distributedand archived according to written procedures.A Poorly Designed System is a burden to all!A simple system is always the most difficult to design. J.Ramniwas 11
  • 12. Manufacturers RoleComply with GMP regulationsProvide Quality medications to patientsProvide documentation to support the quality of the productsfrom development to market and to product discontinuationProducing documents is also part of the production 12
  • 13. Principles of Good Documentation The heart of GMP is the establishment of well written procedures for each step of our quality operations Documentation is used for full traceability of events – cross reference all related documents – audit Written procedures provide the controls necessary to minimize the changes, mix-ups and errors Ensure compliance with GMP regulations but more importantly, we ensure the consistent Quality of our products. 13
  • 14. Proof of Quality• As a pharmaceutical company, your proof of success is found in the documents records that you keep.• Documentation is your proof that your products/ services are produced in compliance with the GMP regulations and your company’s operating procedures and standards.• Key Documents : Development Records, Clinical Trial Records, process and method validation, production batch records, OOS, Deviations, Investigations, Equipment Calibration and preventive maintenance, Training Records, CAPA, Complaints, Change Control etc.. 14
  • 15. Who Reads your Documents Internal• Colleagues• Supervisors and managers• Data Reviewers• QA• Global Network Colleagues External• Regulators – Local and Foreign• Customers – Local and Foreign• Lawyers• General PublicWrite documents as though you are writing history.Write for future viewers 15
  • 16. Basics of Record Keeping• Where your signature is required, write your name legibly and in ink – always use include the date of signing.• Always document as soon as a task is performed• For all critical steps, a second person is required to verify the entered data• Do not document someone else’s work unless you are designated to do so.• Do not assume work has been properly documented without seeing the work and / or the documents, e.g. blame for fraudulent action 16
  • 17. Real Time Formats and Dates• Data entered directly as it occurs• Scratch paper or sticky notes must not be used• Records are signed and dated on the day (and time) the work was performed• Consistent date format is important for a company e.g. day/month/year or year/month/day • Alpha-numeric dating is preferred • 01 Nov 2008 is preferred over 01-11-2008 • Each page should have the current date(s) – no back dating. 17
  • 18. Calculation and NumbersWrite down the formula and perform one sample calculation.No calculation is required for simple mathe.g. 1+4 =5Prevent using down arrow or ditto marks to show repetitivenesse.g. 18
  • 19. CorrectionsNo over writtenNo use of white fluidNo outCritical corrections or omissions must be addressed and signedby management on raw data recordData on damaged pages should be re-entered for clarity, initial,date and explanationAll corrections must be initiated and dated by the analyst andreviewer when applikable applicable John 01 Nov.2008 19
  • 20. Documentation PracticesDocumentation requires that record, sign and date every step ofthe operations that we perform e.g. production batch recordsDocumentation should always be done promptly, accurately,legibly and in accord with our written procedures e.g. labnotebooksA check list serves as a check and double check against costlyomissions, mix-ups and errors. It is used to avoid mistakes andensure completeness of activitiesThere must be written procedures for process control activities i.e.SOP. These procedures including changes, must be reviewedand approved by the organizational unit and QA 20
  • 21. Documentation PracticesPermanent ink – No pencilAll pages numbered and filled out consecutively. No blanks to be filled in laterBlank or unused pages voided with a line, initiated and datedSmall “fill in the blank” lined out with” “ or “N/A”. 21
  • 22. Control of RecordsGMP DOCUMENTS shall not leave the company • Do not take them homeDo not throw away GMP documentsFull reconciliation of each piece of document e.g. sample labels,chromatograms, investigation reportArchive area • Security Access • Document Withdrawal and Return Log • Smoke Alarms • Off-site back system for electronic files • Disaster recovery plan 22
  • 23. Electronic /Computerized RecordsRecords that are required to be maintained under predicate rule requirements • Maintaining in electronic format in place of paper format – Part 11 records • Maintain in electronic format in addition to paper format –rely on electronic record to perform regulated activities ( Business practices) –Part 11 records • Document the business practices in an SOPAudit trial for part 11 RecordsBackup records are maintained for electronic recordsElectronic data must be readily retrievable in a print formatElectronic signatures (e.g. approve, review and verify ) should be authenticated andsecure. When used such a system must be evaluated and tested for security,validity and reliability, Records of those evaluations and tests must be maintained. During the retention period such records must be secured and accessible within 48hours to manufacturer , packager, distributor and importer. 23
  • 24. GMP Numbering SystemSome documents require two numbers to be identifiedcompletely,• A document number – tells what it is• A revision number –tells which one it is 24
  • 25. SOP NumbersGroup SOPs by categories• Personnel• Quality Assurance• Quality Control• Records• Manufacturing• Packaging• Distribution• Building and facility• Equipment• Raw materials and packaging components• Development• EngineeringRecommend alphanumeric numbers and revision numbers e.g. QAD123 v 03 25
  • 26. Lot NumbersLot numbers are assigned as • Receiving Lot numbers • Production / in-house lot numbersTo trace an item or a product from planning , staging, production,testing to marketTo identify an item completely, both the lot number and the partnumber are required 26
  • 27. Part Numbering SystemPart number should be unique to each A Simple Sample Part Numbering Systemitem • Sodium Chloride USP Grade – Use in 1000-1999 Raw Materials* production 2000-2999 Packaging Components* • Sodium Chloride ACS Grade – Use in 3000-3999 In-process Materials* laboratories 4000-4999 Printed Materials andConsider grouping by Suppliers Labels*ERP,SAP, or Manual Inventory System 5000-5999 Finished Products* • Numeric Numbering 6000-6999 Materials Prepared • Alpha-numeric numbering In-house*Part number can be retired but never 7000-7999 Non-inventory chemicals*reassign Part numbers 8000-8999 Non-inventory Components* * Inventory Items 27
  • 28. Document NumbersLaboratory notebook numberEquipment logbook numberValidation Protocol NumberOOS numberCAPA numberComplaint numberChange number…… etc 28
  • 29. Types of Documents in Manufacturing Labels Specifications and testing procedures Master formulae and instructions Batch processing and batch packaging records Standard Operating Procedures (SOPs) Logbooks Records Stock control and distribution records Other documents … 29
  • 30. Standard Operating ProceduresWritten commitments to regulators that describe the routine tasksDescriptions on how to perform various routine operationsStep by step instructions that technicians in QC, Production,maintenance, and material handling consult daily in order tocomplete their tasks reliably and consistentlyEffective periods and review frequency 30
  • 31. SOP FormatInformational Categories • Title • Purpose • Scope • Responsibility • Definitions • Reference/ Applicable Documents • Safety Considers • Procedural principles • Preliminary Operations • Procedures • Calculations • Documentation RequirementsEach Page – Title, SOP number, revision number ,paginations, company name,declaration of confidentialityFirst page –approval signatures, date of approval , issue date, next review date 31
  • 32. How to write good SOPsSOP Numbering – simplify and group similar SOPs togetherReduce duplicate SOPs- facilitate training and improve complianceOutside the job – Use process flow diagramsWrite for the readers – i.e. operators, analysts, QA, Customers,Regulators • Right language • Short, simple sentences • Familiar and short words • Write in conversational style • Explain the background, Do not assume people know / remember your processesUse pictures to facilitate understanding, e.g. picture of an HPLCPut procedures in a good package • Selling SOPs to employees so that they will follow procedures • Page design, instructions, table of contents , index , dividers, visual layout, right font size, and types of binders used, intranet access etc. 32
  • 33. Specifications and Test ProceduresPrimary source of information for an item Purchasing InformationSpecification • Specification number and version control • List of approved vendors • Description of each part numbered item • Local Supplier – name and address - Standard Naming convention • Name of company • Manufacturer – Name and Address • Expiration date/ Re-test date • Chemical formula • Minimum Order Quantity • Material • Dimensions • Quantity per Unit • Sampling information e.g. size • Palletization Information • Handling precautions • Storage conditions • Certificate of analysis • Test requirements and method numbers • Acceptance Criteria • Contracts and Agreements - Test before release - Release based on C of A and concurrent testing - Release based on C of A and / or ID testPagination and approval signatures 33
  • 34. Receiving LabelsEach item is labeled with its part number and receiving lot number • Quantity per unit • Total Quantity • Total Number of pallets/ skids • Responsible person – Initial and Date • Transportation conditionsDifferent colors for different types of labels • Quarantine Label – Yellow Color • Sampled Label – Blue Color • Under Hold Label – Orange Color • Release Label - Green Color • Rejection Label – Red ColorBarcode LabelsLabel issuance, usage, destruction and reconciliation document 34
  • 35. Process Development Report The following exemplifies information to be contained in the development report.•Historical data of pharmaceutical development of new drug substances and drug products at stages from early development phase to final application of approval•Raw materials and components•Synthetic route•Rational for dosage form & formula designs and design of manufacturing methods•Rational and change histories of important processes and control parameters•Quality Profiles of manufacturing batches ( including stability data)•Specifications and test methods of drug substances, intermediates, drug products, raw materials, and components, and their rationale( validity of specification range of important tests such as contents impurities and dissolution, rational for selection of test methods, reagents and, columns, and traceability of raw data of those information) 35
  • 36. Master Production RecordsPrepare , sign and date by one Production instructions Sequences to be followedperson and independently • • Critical steps have to be co-signedcheck, sign and date by a by a second operator/ supervisorperson in the Quality unit • Define the ranges of processProduct Description and item parameters • Sampling instructions and in-number process controls with acceptanceFull list of ingredients criteriaAccurate statement of quantity • Time limits for completion of individual processing steps or totalor ratio of each raw material or processintermediate to be used • Expected yield ranges atProduction location, equipment appropriate steps Special storage conditions includingand major utilities • labeling and packing materials Expected production quantity, • S special precautionssample quantity, rejects,reprocessed quantity,% yield 36
  • 37. Production Batch RecordsCheck batch record before issuance to assure the correct version is used- signand date when issueOne batch record for one number ( unique number)For continuous production, the product code with the date and time can serve asthe unique identifier until the final number is assignedFull traceability of records- dates, times , personnel, equipment, raw materials,actives, intermediates, packing components, labels, rejects, in-process and labresults, OOS, investigations, changes, release changes, stability results,environmental conditions etc…Investigation of critical deviations – extend to other batches that may have beenassociated with the specific failure or deviationDocument all deviations during manufacturing and cross reference to otherdocuments if necessary e.g. OOS or unplanned deviationsAttach all process generated paper to product batch records e.g. raw materialweighing records, tablet weight check, statistical process control charts,equipment print outs, equipment and room labels etc.Record production quantity, sample quantity, rejects, reprocessed quantity and %yield 37
  • 38. Production Record ReviewReview and approve by the quality unit to determine compliance with all established , approved written procedures before a batch is released or distributedAny unexplained discrepancy or the failure of a batch or of itscomponents shall be thoroughly investigated, whether or not the batch has already been distributedThe investigation shall extend to other batchesA written record of the investigation shall be made and shall includethe conclusions and follow-up 38
  • 39. Packaging InstructionsMaster packaging instruction – formally authorizedPackaging instruction• Strengths, dosage forms, size( by volume, weight or counts), packaging materials, packaged lot number• Location of packaging line• Date, time and personnel• Labels and print components – keep samples coded with lot number and expiry date, reconciliation and control• Line clearance checks – before and after• In-process controls from shift to shift• Samples control• Special precautions 39
  • 40. Equipment RecordsUsage logs • Product / Batch Number/ Person/ Date/ TimeCleaning/ Sanitation/ SterilizationMaintenance • Person, date, time, resultsDedicate Equipment – One intermediate or one product • Individual equipment records are not necessary if batches are traceable sequence 40
  • 41. Laboratory GlasswareAll in-process solutions, glassware, media tubes or plates, sample extracts and anything used in testing must be clearly labeledand identifiedLaboratory glassware with labels are kept until laboratoryreports are reviewed and approved Product : ABC Lot Number : 130 Sample :#1 Analyst initial & Date : 41
  • 42. Raw material and Packaging Component RecordsExternal• Name(s) of manufacturer/distributor• Batch Number/ Item Number/ Labeling• Quantity of each shipment / Quantity per skid / Quantity per unit• Date of receipt/ expiry date• Certificate of analysisInternal• Receiving Number / Item number/ Labeling• Sample Size• Test Specification, Identification/ Test Results and release decision• Packaging components, printed components and labels• Master approved labels and components for comparison• Inventory of each item, usage records for each material and rejection 42
  • 43. Laboratory RecordsComplete lab data derived from all tests and lab equipmentCompliance with established specifications and standardsFull traceability – dates, time, samples, quantities , suppliers, personnel,equipment, reference standards, reagents, standard solutions, testmethods, graphs, charts, spectra, chromatograms, calculations,conversion factors, test results, comparison to previous trends andvalidation batches, changes to methods, OOS Signature of the person who performed each test and the dates(s) thetests performedSignature and date of second person showing that the original recordshave been reviewed for accuracy, completeness and compliance withestablished standards. 43
  • 44. Laboratory DataRaw data are necessary for support, reconstruction andevaluation of test reportRaw data may include , but is not limited to , photographs,microfilm, computer printouts, labels, magnetic media, includingdictated observations, and recorded data from automatedinstrumentsAll raw data are kept with the test reports, unless there areelectronic records or other means of recording 44
  • 45. Out of Specification and Re-testingOOS FORM Plus all related documentsInitiate OOS investigation as soon as OOS is foundAny repeat testing or retesting due to laboratory error or instrumentproblems must be approved by management prior to testing againOnly management has the authority to invalidate a result 45
  • 46. Data ReviewThe raw data and lab records are very importantDocumentsBefore any product is released to the market, acomplete check of production and laboratoryrecords is made to make sure the product meetsthe quality standardsWhen you sign your name on the appropriaterecords, you are, in essence becoming anhistorian for that process. 46
  • 47. Stability RecordsDemonstrate that the product meets its established specifications during the product shelf lifeTest product in its final package in which it is soldOn-going stability program: 0,3,6,9,12,18,24,36 …monthsTest with in the required time frame 47
  • 48. Deviation RecordsDeviation Form + all related documentsFull investigation – Describe the background , the environment,personnel involved, root causes , risk assessment , conclusions,corrective and preventive actions(CAPA)Write with short and simple sentencesWrite for someone who does not know your proceduresWrite for someone who will read this document few years fromnow. 48
  • 49. Change Control RecordsRegulations and Requirements -What functions a Change Control system must- Change control as critical part of the perform validation life cycle - How the organizational culture can affect the- How to set up Change Control, successful implementation of Change Control Documentation Systems - Types of Changes- Preparing Change Control SOPS & Forms - Different levels of change (major, minor, critical)- Processes involved to efficiently control and distinguishing them and document changes to: - Types of reviews and approvals- Manufacturing processes - Roles and Responsibilities- Facilities Signature meanings- Product - How your Change Control system may be- Elements of Change Control Management examined by investigators- Change Control process for computerized - Change Control checklists - Personnel Training systems - Scale Up and Post Approval Changes – SUPAC- Change Control in API and Drug Product - Bulk Actives Post Approval Changes - BACPAC industries- How to organize change documentation to withstand regulatory queries during field inspections? 49
  • 50. Training RecordsIt is the responsibility of each employee/management to maintain their ownand their departments training recordsYou can perform a test or task until you and your trainer have completed the training and signed -off on the procedure.Certain tests require performance assessment before QualificationMust document the training on new and revised SOPs issued throughout the year.Training Records should be reviewed during annual performance reviewbetween the manager and the employee. Document any additional trainingfor the new year.For human errors on OOS or deviations – employee training records need to cross link to corrective and preventive actions. 50
  • 51. Organisation Charts Dated and version controlName of all personnel involved in GMP activities anddecision making.Provide information on full time, part time and contractstaff.Provide global reporting structures for multinationalorganizations. 51
  • 52. Job DescriptionJob descriptions are written statements that describe the:• Duties,• Responsibilities,most important contributions and outcomes needed from a position, required qualificationsof candidates, and reporting relationship and co-workers of aparticular job.Job descriptions are based on objective information obtained through job analysis, anunderstanding of the competencies and skills required to accomplish needed tasks, and the needs of the organization to produce work.Job descriptions clearly identify and spell out the responsibilities of a specific job.Job descriptions also include information about working conditions, tools, equipmentused, knowledge and skills needed, and relationships with other positions.The best job descriptions are living, breathing documents that are updated asresponsibilities change.The best job descriptions do not limit employees, but rather, cause them to stretch theirexperience, grow their skills, and develop their ability to contribute within theirorganization. 52
  • 53. Technology Transfer Documents Like for like transfers.Levels of changes require for changes.Risk assessment for changes within the “Design Space”From one site to another site.From R&D to productionTransfer protocols – before and afterChange control or deviation during transferValidation status after transfersStability studies 53
  • 54. Validation DocumentationValidation Protocol – before validation • How validation of a particular process will be conducted • Specify the type of validation e.g. retrospective, prospective or concurrent and the number of process runs • Specify critical process steps and acceptance criteria - Important to put down the pre-determined specifications otherwise , any result can be claimed as ‘ validated’. - Important to justify which are the priority parameters to be validated , since we may not be able to validate all combinations of resultsValidation Report – After Validation • Cross reference the validation protocol • Summarize the results, deviations, changes and conclusions • Recommend changes to correct deficiencies • Justify any variations from the protocol • Review and approve by the designated units and QA 54
  • 55. Management Review MinutesAttendanceMeeting Dates and FrequencyDiscussions of Quality trends and issues• Identify responsible person(s) for CAPA• Target dates for actionsFollow-up with previous minutes and actionsEscalation Process 55
  • 56. Documents involved External Stake HoldersResponse to Regulatory InspectionsResponses to customer inspectionsComplaintsProduct RecallsAnnual Product Quality ReviewPost- market adverse drug events reportsWrite for the readersWrite for the future 56
  • 57. Response to Regulatory InspectionsRespond on timeA cover letter and a separate on responsesUnderstand the GMP aspects of comments and respond tothe commentsIdentify root causesProvide corrective and preventive actions with target datesInclude responsible department/function –names are notnecessary 57
  • 58. ComplaintsSOPs for handling of all written and oral complaintsTrain all employees on how to document complaintsComplaints involving the possible failure of drug product to meetany of its specifications – to be reviewed by the Quality Control UnitComplaint represent serious and unexpected adverse drugexperience – require to be reported to FDAMaintain complaint records at least 1 year after the expiration dateof the product or 1 year after the date that the complaint wasreceived, whichever is longerWhere investigation is not conducted, the written record shallinclude the justification that an investigation was not necessary and thename of the responsible person making such a determination 58
  • 59. Product RecallsInvestigations, root cause analysis, CAPADifferent levels of recalls have different regulatoryrequirements • Class- 1 – Recall from the market place • Class-2 • Class-3Distribution records – Full Traceability of Quantitiesdistributed and the customers • Includes sales records of drugs and professional samples • Enable a complete rapid recall of any lot or batch of a drug 59
  • 60. Health and Hygiene RecordsSanitation and hygiene should be practiced toavoid contamination of personnel and duringmanufacturing of products.It should cover all aspects of manufacturing: Personnel Premises Equipment and apparatus Production materials and containers Products for cleaning and sanitation All potential sources of contamination 60
  • 61. Pest and Rodent Control RecordsWritten pest control programPest Control and Rodent Control Site mapLog book of Rodent and Insect TrapsInsect and Rodent Trap cleaning recordOutsourcing is recommendedUse of safe pest control agentsMSDS of all pest control agentsNo risk of contamination to the materials andproductsProper records 61
  • 62. Regulatory Observation Related to Documentation Issues There are no written procedures for production and process controls designed to assure that t he drug products have the identity, strength, quality and purity they purport to possess. Written procedures have not been developed for the surveillance, and receipt of post marketing adverse drug events. Firm failed to follow their SOPs on OOS investigations. Samples were re-tested before any investigat ion was conducted. The operator who manufactured a batch of sterile product has no documented training on sterile production. Investigations fail to be conducted within a timely manner. The time frame for completion is required i n SOP. The SOP places no limitations for the number of times a time frame may be extended, nor does it identify the number of days allowed to extend a timeframe. A portion of batch was rejected. The in-process solution made for the rejected portion of the batch was not reconciled .There was no record of the disposition of the excess quantity of the excess material. Lab records are deficient in that they do not include a complete record of all data generated during testing. There was no record on how many chromatograms were generated. The firm communicated GMP related information through electronic mails .Investigation and product decisions were made on emails. Contents of these emails are not archived or transcribed in to formalized records required by the regulations. 62
  • 63. Stock Control and Distribution Records What should be recorded? Where should records be stored? Why are the records important? 63
  • 64. Design a Good Documentation SystemNot a one size fits all approachUnique operations and unique productsComplement the cultural environment of the corporationBe the expert in your systems, operations, products andservices.Do not create a system to satisfy one part of the corporation J.Ramniwas 64
  • 65. Revision and Renewal of Documents Should be made periodically, or if needed Obsolete documents should be retrieved from all relevant parties and its original copy should be archived The date of revision should be stated in the new documents Every revision should be approved by authorized person J.Ramniwas 65
  • 66. A Good Documentation Practice: A Life Style ApproachWhen you care enough to make GDP a life style and not just a regulation, you do more the signing documents – we put our name on job well done.Write it down – Keep good recordsIf it is not documented, it is a rumourThere can be no substitute for a clear commitment to entering data• Correctly• Completely and• Chronologically and right first time J.Ramniwas 66