Batch packaging record for sterile water for injection

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BATCH PACKAGING RECORDS FOR STERILE WATER FOR INJECTION....

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Batch packaging record for sterile water for injection

  1. 1. BATCH PACKAGING RECORD FOR STERILE WATER FOR INJECTION 1 Presented By : RITIKA U. GAJRE. Roll no : 14 M.Pharm (Q.A.) 2nd Shift Guided by : Nikita patel
  2. 2. CONTENTS Documentation  Purpose of documentation  Types of Documentation  Packaging Instruction  What is batch packaging record….?  Components of batch packaging record format for sterile water for injection  2
  3. 3. DOCUMENTATION The document is information and its supporting medium , which could be in paper form , c.d , computer files , or microfilm.  Good documentation consists an essential part of quality assurance system.  Clearly written documentation prevents errors from spoken communication and permits tracing of batch history.  Specification, Manufacturing formulae and instruction, procedures and records must be free from errors and available in written.  3
  4. 4. PURPOSE OF DOCUMENTATION o o o To define the specifications and procedures for all materials and methods of manufacture and control. To ensure that all personnel concerned with manufacturing know what to do and when to do it. To ensure that authorized persons have all the information necessary to decided whether or not to release a batch of a drug for sale. 4
  5. 5.  To ensure the existence of documented evidence , traceability and to provide records and an audit trail that will permit investigation  And to ensure the availability of the data needed for validation , review and statistical analysis. 5
  6. 6. TYPES OF DOCUMENTATION  Guideline :To provide recommended practices and instruction.  Policy :It is document to establish the organization interpretation and attitude toward the regulatory body. 6
  7. 7.  Standard operating procedure ( sop) :To provide detailed instructions on how to implement a process or perform a specific activity.  Records :It is a document stating results achieved or providing evidence of activities performed. 7
  8. 8.  Form sand templates :Are a prestructured document with blank spaces designed for insertion of required information.  Manual :To provide inform action on how a system or equipment operate. 8
  9. 9. PACKAGING INSTRUCTION  There should be formally approved packaging instructions for each product pack size and type. These should normally include, or make reference to the following:  (1) The name of the product.  (2) A description of its pharmaceutical form, strength, and method of application where applicable.  (3) The pack size expressed in terms of the number, weight, or volume of the product in the final container. 9
  10. 10.  (4) A complete list of all the packaging materials required for a standard batch size, including quantities, sizes, and types, with the code or reference number relating to the specifications for each packaging material.  (5) Where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked.  (6) Careful examination of the packaging area and equipment in order to ascertain the line clearance before operations begin 10
  11. 11.  (7) A description of the packaging operation, including any significant subsidiary operations, and equipment to be used  (8) Details of in-process controls with instructions for sampling and acceptance limits. 11
  12. 12. BATCH PACKGING RECORDS consists :  Packing work order.  Over printing details  Packing details  In-process checks  Over printing  Bottle washing and filling (liquid orals)  Bottle cleaning and filling (Dry Syrup)  Packing  Shipper weight profile  Deviation record (if any) 12
  13. 13. BATCH PACKGING RECORDS  A batch packaging record should be kept for each batch or part batch processed. It should be based on the relevant parts of the packaging instructions.  The following information should be recorded at the time each action is taken and, after completion, the date and the person responsible should be clearly identified by signature or electronic password: 13
  14. 14.  (a) The name of the product, the batch number, and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained, the quantity actually obtained, and the reconciliation.  (b) The date(s) and time(s) of the packaging operations.  (c) The name of the responsible person carrying out the packaging operation.  (d) The initials of the operators of the different significance. 14
  15. 15.  (e) The checks made for identity and conformity with the packaging instructions including the results of in-process controls.  (f) Details of the packaging operations carried out, including references to equipment and the packaging lines used, and, when necessary, the instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area.  (g) Whenever possible, samples of the printed packaging materials used, including specimens bearing the batch number, expiry date, and any additional overprinting. 15
  16. 16.  (h) Notes on any special problems, including details of any deviation from the packaging instructions, with written authorization by an appropriate person.  (I) The quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed, or returned to stock and the quantities of product obtained to permit an adequate reconciliation. 16
  17. 17. STERILE WATER FOR INJECTION  It is a sterile, bacteria-free, solutefree preparation of distilled water for injection.  It is used as a sterile solvent or diluent vehicle for drugs or solutions suitable for intravenous or intramuscular administration.  In this application, it provides water for hydration and the drug delivery to the patient.  The pharmacist typically introduces these additives and relabels the container for patient application. 17
  18. 18. COMPONENTS OF BATCH PACKAGING RECORD FOR STERILE WATER FOR INJECTION  Name of the product  Batch no.  Formulation  Date & time code no. & pack no. 18
  19. 19.  Packaging  operation ( A )line clearance  In-process checks  Initial of packing check 19
  20. 20. BPR OF PARENTRALS PACKAGING DESCRIPTION : ____________________ PRECODING OF LABELS AND PRINTED PACKAGING MATERIALS EXAMINED AND VARIFIED BY : _____________ (Attach specimen) NO. OF PRECODED : _______________ LABELS RECEIVED : ___________ PRINTED PACKAGING MATERIAL RECEIVED : ______________ 20
  21. 21. DATE START TIME CLOSE TIME NAME OF PERSON RESPONSIBLE FOR PACKAGING OTHER OPERATION PACKAGING CHEKING PACKED VIALS COUNTING & FILLING CARTONS 21
  22. 22.    TOTAL QUANTITY PACKED : ___________ DATE OF COMPLETION : ___________ QUANTITY COLLECTED AS SAMPLES BY QC DEPARTMENT : ____________ SIGN OF PRODUCTION DEPARTMENT SIGN OF QA DEPARTMENT 22
  23. 23. PACKAGING OPERATION A. LINE CLERANCE Packing line no Previous product Batch no 23
  24. 24. sr.no Activity 1. Removed checked Done by Checked by Labeled vials, delabelled vials, cartons, Insert , wrappers of the previous product/b.no on the table 24
  25. 25. 2 Labels ,cartoons ,inserts of previous product near the labeling machine 3 Waste from dustbin's 4 Rejected vials ,labels ,cartons ,inserts of previous product,/b.no for destruction 5 Stamps removed of previous product /b.no 6 Packed shippers shifted of previous product/b.no to BSR 25
  26. 26. REFERENCES 1) Annurex 3 WHO good manufacturing practices for Pharmaceutical products : main principles , WHO Technical report series no.961 ,2011 pg.no133 ,135 2)http://www.authorstream.com/Presentation/ch etu30-1217989-bpr/ 3)http://www.authorstream.com/Presentation/K unalvanparia-1649012-batch-packagingrecord/ 26
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