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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 & 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 & 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 & 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 tra