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Good practices in production

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Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality.

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Good practices in production

  1. 1. Good Practices in Production Presented By Md. Shariful Islam Department of Pharmacy International Islamic University Chittagong
  2. 2. Good Practices in Production: General Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorizations, with the objective of obtaining products of the requisite quality.
  3. 3. Good Practices in Production: General  All handling of materials and products;  receipt  cleaning  quarantine  sampling  storage  labeling  dispensing  processing  packaging  distribution  should be done in accordance with written procedures and recorded.
  4. 4. Good Practices in Production: General  Any deviation from instructions or procedures should be avoid as far as possible.  If deviations occur: should be done in accordance with an approved procedure  approved in writing by a designated person
  5. 5. Good Practices in Production: General  Checks on yields and reconciliation of quantities to ensure that there are no discrepancies outside acceptable limits.
  6. 6. Good Practices in Production: General  Operation on different products should not be carried out simultaneously or consecutively in the same room or area unless there is no risk of mix-up or cross-contamination.
  7. 7. Good Practices in Production: General  At all time during processing  all materials  bulk containers  major items of equipment  rooms  packaging lines  being used should be labeled or identified
  8. 8. Good Practices in Production: General  Access to production premises should be restricted to authorized personnel.  Non-medicinal products should not be produced in areas or with equipment destined for the production of pharmaceutical products.
  9. 9. Good Practices in Production: General  In-process controls are usually performed within the production area.  The performance should not have any negative effect on the quality of the product or another product.
  10. 10. Good practices in production: Prevention of cross-contamination during production  When dry materials and products are used in production, special precaution should be taken to prevent the generation and dissemination of dust.  proper air control e.g. supply and extraction of air of suitable quality
  11. 11. Good practices in production: Prevention of cross-contamination during production  Contamination of a starting material or of a product by another material or product must be avoid.  accidental cross-contamination arises from  uncontrolled release of dust, gases, particles, vapours. sprays or organisms from materials and products in process  residues on equipment  intruding insects  operators’ clothing, skin, etc.  most hazardous, highly sensitizing materials  living organisms, hormones, cytotoxic substances, and others
  12. 12. Good practices in production: Prevention of cross-contamination during production  Avoided by taking appropriate technical e.g.  carrying out production in dedicated and self-contained areas  conducting campaign production followed by appropriate cleaning in accordance with a validated cleaning procedure  providing appropriately designed airlocks, pressure differentials and air supply and extraction systems
  13. 13. Good practices in production: Prevention of cross-contamination during production  minimizing the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air  wearing protective clothing  using cleaning and decontamination procedures of known effectiveness  using a closed system in production  testing for residues  using cleanliness status labels on equipment
  14. 14. Good practices in production: Prevention of cross-contamination during production  Measures to prevent cross-contamination and their effectiveness should be checked periodically according to SOP.  Production areas periodic environmental monitoring
  15. 15. Good practices in production: Processing operations  Before any processing operation  work area and equipment  clean and free from any starting materials, products, product residues, labels or documents not required for the current operation.
  16. 16. Good practices in production: Processing operations  Any necessary in-process controls and environmental controls should be carried out and recorded  Indicate the failures of equipment or services (e.g. water, gas) to equipment  defective EQ withdrawn  after use, production EQ  cleaned without delay,  stored under clean and dry conditions in separate area
  17. 17. Good practices in production: Processing operations  Time limits for storage of EQ after cleaning and before use  Containers for filling should be cleaned before filling  Any significant deviation from the expected yield  recorded and investigated
  18. 18. Good practices in production: Processing operations  Checks  pipelines and other pieces of EQ used for transportation of products  Pipe used for conveying distilled or deionized water  sanitized and stored according to written procedures (action limits for microbiological contamination and measures
  19. 19. Good practices in production: Processing operations  EQ and instruments  serviced and calibrated at prespecified interval  records maintained  checked daily or prior to use  clearly indicated the date of calibration and servicing, recalibration (label attached to instrument)  Repair and maintenance operations  not present any hazard to the quality of the products

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