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<ul><li> 1. DDEEVVEELLOOPPMMEENNTT OOFFPPHHAARRMMAACCEEUUTTIICCAALLDDOOCCUUMMEENNTTAATTIIOONN</li></ul><p> 2. Document is a written report or record thatprovides information. Documentation is a method of preparing awritten material, which describes the processin terms of specifications ,instructions etc. 3. Document is a piece of written, printed orelectronic matter that provides informationor evidence. A Good Documentation is essential part ofQA system . Documentation is an important aspect inpharmaceutical industry irrespective of thefact the manufacturing plant is involved inproduction of dosage form (or) activeingredient. 4. IImmppoorrttaannccee ooff ddooccuummeennttaattiioonn It provides the working details necessary for manufacturing,packaging, quality control. Reduce the risk of mistakes inherent in verbal communication. They help in decreasing the batch to batch variation so thatquality of product is kept with in the limit of acceptability. Documentation and records are essentials for obtainingACCREDIATION ,certification of ISO, and approval by Federalbodies. 5. AAiimmss ooff ddooccuummeennttaattiioonn To define the specifications for all materials To define the methods of manufacture and control To instruct the personnel To provide information during investigation To helps in inspection or auditing by Regulatoryauthorities. 6. WHY DOCUMENTATION:There is a saying in the pharmaceutical industry: 'ifit hasn't been documented, then it hasn'thappened!'Good documentation practice constitutes anessential part of the QA system.Documentation system must be proactive vehicleof communication.YOUR DOCUMENTATION IS ANADVERTISEMENT FOR YOUR WORK. 7. To design an effective &amp; efficientdocumentation Identify the important characteristics of processingevent.The document directing the manufacturing eventfulfills current regulatory commitments to the agency;it is appropriately written, reviewed and approved.The directive document is appropriate for the task tobe performed. 8. The data is authentic, accurate, complete, legible,accessible.The data collected fulfills expectations(specifications) and is retrievable for review oraudit.All documentation should be legible, clean,readily identifiable, retrievable and maintainedin facilities that provide a suitable environmentto minimize deterioration or damage and toprevent loss. 9. TYPES OF DOCUMENTSCommitment Documents : Relationship betweenindustry and the regulatory authorities.EX: New Drug Applications (NDAs), Drug Master Files (DMFs) etc.Directive Documents : Relationship between theManagement and Employees.EX: Specifications, STPs, Standard Operating Procedures (SOPs),Medicinal Product Records (MPRs) etc.Record Documents : Relationship between the Employeesand the Work they perform.EX: Protocols, Batch Production Records (BPRs), Log Books,Calibration Records etc. 10. Commitment DocumentsThese present corporate goals, expectations and standard ofpractice. It describes what to do. Consensus of purpose, direction and authorization forprojects. It organizes the work in a manner that assures efficient andeffective work flow. Commitments documents can also be written to establishinternal commitments. Written to lead and guide the work andworkers. 11. These documents such as master plans; organize andprioritize the work in a manner that supports good businesspractice as well as regulatory compliance.To be used as active documents that are consulted andfollowed routinely.Content must be consistent and rigorous in order to leadand guide the work and the workers.Must describe the work as it will be done.Deviations from regulatory submissions can havesignification impact on product quality.Any deviation must be documented and managed. 12. New Drug Applications (NDAs):The New Drug Application (NDA) is thevehicle in the United States through which drugsponsors formally propose that the FDA approvea new pharmaceutical for sale and marketing. 13. The goals of the NDA are to provide enoughinformation to permit FDA reviewers to establishthe following:Is the drug safe and effective in its proposed use(s) whenused as directed, and do the benefits of the drug outweighthe risks?Is the drugs proposed labeling (package insert)appropriate, and what should it contain?Are the methods used in manufacturing (GoodManufacturing Practice, GMP) the drug and the controlsused to maintain the drugs quality adequate to preservethe drugs identity, strength, quality, and purity? 14. Drug Master Files (DMFs):Drug Master File (DMF) is a documentcontaining complete information on an ActivePharmaceutical Ingredient (API) or finished drugdosage form. The document provides the regulatory authority withconfidential, detailed information about facilities,processes, or articles used in the manufacturing,processing, packaging, and storing of one or morehuman drugs. 15. Drug Master File or DMF is a document prepared by apharmaceutical manufacturer and submitted solely at itsdiscretion to the appropriate regulatory authority in theintended drug market. It is known as European Drug Master File (EDMF) orActive Substance Master File (ASMF) and US-Drug Masterfile (US-DMF) in Europe and United States respectively. The DMF contains factual and complete information on adrug product's chemistry, manufacture, stability, purity,impurity profile, packaging, and the cGMP status of anyhuman drug product. 16. Directive Document:Working documents that establish the standards forresources, processing, products &amp; quality system.Describe how to do it???Describe how to do routine work.Several types of directive documents.The different types are determined by the specific, functionalpurpose of the document in the document system.In order to facilitate the development, production, testing anddistribution of a product in a defined manner.Reviewed and approved by both management and theindividuals responsible for performing the work. 17. Specifications:A document specification contains several parts: a description of the audience(s) for the document a detailed outline giving the structure and contentsof the document a work plan showing who is responsible for eachpart of the document what the deadlines are for completing each task. 18. Three purposes for documentspecifications:In the workplace, formal document specificationsserve three important functions: economy of effort, work planning, writing organization. 19. Standard Operating Procedures (SOPs):Standard Operating Procedures (SOPs) are issuedto specifically instruct employees in areas ofresponsibility, work instructions, appropriatespecifications and required recordsA Standard Operating Procedure (SOP) is a set ofwritten instructions that document a routine orrepetitive activity followed by an organization. 20. Record document:Protocol: Protocols are written records clearly defining the objectivesand methods that will be used for the validation programs. An important part of the protocol is the description of thetesting method including who will test the system, how theywill test it and what data is to be collected and reported. Computerized system protocols often include the threedistinct stages as described in PMA reports: InstallationQualification (IQ), Operational Qualification (OQ),andPerformance Qualification (PQ). 21. Protocol Changesdocumented requirements specifying who and howchanges to parameters, thresholds, and acceptancecriteria are made after approval.It is not impossible to make changes after or duringtesting, but these changes must be properlyimplemented and approved to be validatable. 22. What Good Documentation requires:APPROVALCLARITYREGULAR REVIEW AND UPDATEFORMAL PRESENTATION 23. PROTOCOL FOR DOCUMENTATION1.Serial number of the Batch Manufacturing Record.2.Name of the product.3.Reference to Master Formula Record.4.Batch/Lot number.5.Batch/Lot size.6.Date of commencement of manufacture and date ofcompletion of manufacture.7.Date of manufacture and assigned date of expiry.8.Date of each step in manufacturing.9.Names of all ingredients with the grade given by thequality control department.10.Quality of all ingredients. 24. 11. Control reference numbers for all ingredients.12. Time and duration of blending, mixing, etc. wheneverapplicable.13. pH of solution whenever applicable.14. Filter integrity testing records.15. Temperature and humidity records whenever applicable.16. Records of plate-counts whenever applicable.17. Results of pyrogen and/or bacterial endotoxin &amp; toxicity.18. Results of weight or volume of drug filled in containers.19. Bulk sterility in case of aseptically filled products.20. Leak test records.21. Inspection records.22. Sterilization records including autoclave leakage test records,load details, date, duration, temperature, pressure, etc.23. Container washing records. 25. 24. Total number of containers filled.25.Total numbers of containers rejected at each stage.26. Theoretical yield, permissible yield, actual yield andvariation thereof.27. Clarification for variation in yield beyond permissibleyield.28. Reference numbers of relevant analytical reports.29. Details of reprocessing, if any.30. Name of all operators carrying out different activities.31.Environmental monitoring records.32. Specimens of printed packaging materials.33. Records of destruction of rejected containers printedpackaging and testing.34. Signature of competent technical staff responsible formanufacture and testing. 26. STEPS IN PMD PROGRAMME1.Identify at least two or more fairly knowledgeablepersons, one each from production and QC/QA who arefamiliar with organization product .2.List out manufacturing formulation departments existingor planned .3.List out the QC /QA ,engineering,warehousing,personneland other actives.4.List out countries to which the product are likely to besold/distributied and collect the specific PMDrequirements . 27. 5. Categorization of documents shouldbe following Documents forpersonal training QC/QA. Building/factory Equipment Materials/stores Engineering Distribution.Each category can besplit into following SOPs Lists Charts/formats Specifications Test methods Reports 28. 6. Design the documents-considering the followingpoints Contents Formatting Size and quality of paper etc.,.7. Explain the document to people concernedTrain them in using the same8.Trail run the documents, study the difficulties, modifyand redesign9. Implement the document10. Review by receiving feed back from the users atregular intervals. 29. GGeenneerraall rreeqquuiirreemmeennttssEach document should have: Have a clear title Have an identification number Be approved by authorized person have the date of issue document should not be hand written Records should be retained at least one yearafter the expiry date of the finished product 30. Designing of documents involves the followingfactors : Size of the paper Color of the paper All four sides margin must be define generally 25mm from left and 15 mm all sides All documents must match the requirementsdescribed in manufacturing and marketingauthorization. All documents must bear the name of the companyand logo, if applicable 31. All documents must be approved, authorised,signedand dated by the authorized person. Title and contents of the documents must be selfexplanatory. Generally every document must be review everytwo years or earlier. 32. When you design a document, run a dummy trailof the document. Users must be well trained in using a document Normally all records must be stored for 1 yearafter the shelf life of the product . 33. GGMMPP GGuuiiddeelliinneessGMP guidelines specify certain documents tobe maintained necessarily:1. Labels2. Specifications and testing procedures3. Records4. SOPs 34. LLaabbeellss Labels are used for identification or status ofcontainer, equipment and premises. According to status of container the followingcolor labels are used Quarantine -- yellow Approved -- green Rejected -- red 35. GGuuiiddeelliinneess ffoorr llaabbeellss Label of finished product contains Name of the drug product List of the active ingredients, qty Net contents Batch number Expiry date Storage conditions Name and address of the manufacturer 36. a Specifications anndd tteessttiinngg pprroocceedduurreess In case of pharmaceutical products we needspecifications for Active and inactive starting materials Primary ,printed and other packaging materials Intermediate and bulk products Finished pharmaceutical products 37. RReeccoorrddssVarious documents maintained in productiondepartment are Raw material records Master formula records Batch production records Quality control records Calibration records to instrument Records for stability studies 38. RRaaww mmaatteerriiaall rreeccoorrddssSchedule U shows the following particulars for raw materialrecords Date of receipt Invoice number Name and address of manufacturer Batch number Quantity received Pack size Date of manufacture Date of expiry Quantity and date of issue 39. MMaasstteerr ffoorrmmuullaa rreeccoorrddss Master formula record are defined as writtenprocedures that give complete description of allaspects of mfg, packing,&amp; control with intention toensure the purity, identity quality &amp; strength of theproduct. Master formula records should be prepared bycompetent technical staff and should be reviewedby the heads of production and quality controldepartments 40. Master formula records should be described asFollows Name and strength of product along with dosage form Complete list of all ingredients Accurate statement of weight of each ingredient A description of containers , closures , packagingmaterials A description of vessels equipment to be used in therepreparation. Processing and packaging procedures In process controls to be exercised during processingand packaging 41. QQuuaalliittyy ccoonnttrrooll rreeccoorrddssQC records must show Date of performance of test Identification of material Name of supplier Date of receipt Batch number Quantity received Quantity of sample taken Statement of result of test Signature of person who performs the test 42. CCaalliibbrraattiioonn rreeccoorrddss ffoorr iinnssttrruummeennttss The procedure for calibration records mustinclude the following detail Name of the instrument Date of calibration Reference standards used Other reagents or tools used Name and sign of the person who calibrated 43. RReeccoorrddss ffoorr ssttaabbiilliittyy ssttuuddiieessProcedure for stability study records Name of product Complete description of the packaging materialused Period of time during which stability study hasbeen carried out Condition in which product has been storedduring study 44. SSOOPP Sop is a defined as written documentsspecifying the procedures that must befollowed to carryout operations The purpose of a SOP is to provide detailedinstructions on how to carryout task so thatany employee can carryout a task correctlyevery time. SOPs are useful tools for training newmembers of staff 45. SOPCompa...</p>