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Presentation on Weighing & Dispensing.ppt

  2. TRAINING ON WEIGHING & DISPENSING A K M Nurul Alam Chowdhury AGM, Production (ASPL)
  3.  Requirements for production  Facility  Man  Machine  Material  Method (Process)
  4. Facility for Solid Dosages Form Production (Contd.) Production Processing up to Primary packaging. Clean room-class D Maintain pressure difference 10-15 Pascal and negative pressure for production room. Unidirectional flow Air Lock with interlocking system. Dynamic Pass box. Controlled temperature and humidity where required. Separate Man Material entrance. Spares wash dry and storage. IPQC WIP Spares room Maintenance area Technical area.
  5. Facility for Solid Dosages Form (Production) Dispensing Clean room-class D Dispensing booth, Balance, Utensils Maintain pressure difference 10-15 Pascal Controlled temperature and humidity Separate Man Material entrance Utensil wash, dry and storage Weighing Material Day Store Dynamic pass box Air lock
  6. Facility for Solid Dosages Form Production (Contd.) Secondary Packaging Area Controlled Area Maintain pressure difference10-15 Pascal and negative pressure Controlled temperature Secondary Packaging Material Day Store Printing Area Airlock WIP IPQC Spares room Dynamic Pass box (if required)
  7. Facility for Solid Dosages Form Production (Contd.) Personnel Garments Change area: Controlled Area/Clean Area-class D Maintain pressure difference 10-15 Pascal Airlock Air shower Water shower system Disinfections system Individual Dress locker
  8. Man  Establishment and maintenance of satisfactory system of manufacture and control of products and actives rely on people  Must be sufficient qualified personnel to carry out tasks  Individual responsibilities must be clearly defined and understood by individuals concerned  Written job descriptions  All personnel should be aware of the principles of GMP that affect them adequate number of persons  With necessary qualifications  With practical experience  An individual’s responsibilities should not be so extensive as to present a risk to quality  All responsible staff should have specific duties recorded in individual written job descriptions
  9. Facility design that meets WHO cGMP and UK-MHRA stands Environment controlled and monitored through integrated Building Management System (IBMS) supported by latest dynamic software networking to ensure central monitoring and complete automatic operation of the plant. Plant designed with smooth impervious and easy to clean sandwich panels and self-leveling epoxy finish through out all manufacturing area, QC & PDD area. All QC equipments maintained NIST traceable calibration standard. Most modern Purified Water generation with loop system is available to maintain highest quality of purified water as per latest USP guideline. Most modern fire management system also available to manage any fire incident . Environment friendly Effluent Treatment Plant and incinerator are available for management of liquid and solid waste disposal as per local regulatory requirements.
  10. GMP DISPENSING ENVIRONMENT PRODUCT PROTECTION PERSONNEL PROTECTION ENVIRONMENT PROTECTION Contamination (Product & Staff) Prevent Contact with dust Avoid dust discharge Protect from Product Cross-Contamination Prevent Contact with Avoid fumc discharge Correct temperature & humidity Acceptable Comfort Conditions Avoid effluent discharge SYSTEM SYSTEM VALIDATION
  11. Areas where pharmaceutical starting materials, utensils and equipments are exposed to the environment should be classified as clean areas. Weighing and Dispensing operations in separated area. Smooth, impervious (not to be penetrated), durable (permanent) easy to clean finished. Appropriate design – say -Dispensing Booth, Balance, Utensils -Maintain Room pressure -Temperature Control -Humidity Control -Location of Air terminates and direction airflow -Separate personnel flow -Separate material flow -Utensil wash, dry and storage -Dynamic pass box -Air lock -Cleaning procedures and records -Documentation, e.g. SOPs.
  12. Dispensing Booth To Prevent cross contamination of material by environment, human and others during dispensing of pharmaceutical raw materials, a dedicated and confined area under laminar air flow (LAF) unit are used that are called dispensing booth. It facilities with conditioned air through HEPA filter and Maintains positive air pressure in respect adjacent area to prevent flow of external air. Procedures Preparatory phase Personnel must wear clean cloths, headgear, facemask, shoe and hand gloves before entering in dispensing area.