GMP of sterile products


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Overview of gmp of sterile products:

Overview of gmp of sterile products Guided by : Dr. Amol Tagalpallewar Presented by : Mr. Akash Patil (M. Pharm ) DEPARTMENT OF PHARMACEUTICS, SINHGAD INSTITUTE OF Pharmacy, Narhe, Pune-41. 1

Overview of presentation :

Overview of presentation GMP – Good manufacturing practices Objective General consideration Premises Equipments Sanitation 5-Aug-11 2 OVERVIEW OF GMP

Slide 3:

Continued… Personnel Processing Sterilization Packaging & labeling Finishing of products Holding & distribution 5-Aug-11 3 OVERVIEW OF GMP

Slide 4:

Prerequisite programs which will provide the basic environmental and operating conditions that are necessary for the production of safe products. 5-Aug-11 4 OVERVIEW OF GMP

Objectives :

Objectives To review basic GMP requirements in the manufacture of sterile pharmaceutical products. Air classifications for activities related to the manufacture of sterile products. Different types of sterilization methods. Quality assurance aspects in the manufacture and control of sterile products. 5-Aug-11 5 OVERVIEW OF GMP

General Considerations:

General Considerations Production in clean areas Appropriate standard of cleanliness Filtered air supplied Airlocks for entry - equipment - materials Separate areas for operations - component preparation (containers and closures) - product preparation - filling, sterilization, etc. 5-Aug-11 6 OVERVIEW OF GMP


Premises Provide specifically defined area for certain operation. Including designed construction features. Lighting, ventilation, air filtration, air heating & cooling, plumbing, sewage disposal, washing & toilet facilities. 5-Aug-11 7 OVERVIEW OF GMP


Premises(continued) - Avoid unnecessary entry of supervisors and control personnel Operations observed from outside In clean areas, all exposed surfaces - Smooth, unbroken - Minimize shedding and accumulation of particles, microorganisms - Permit cleaning and disinfection 5-Aug-11 8 OVERVIEW OF GMP

Premises (continued):

Premises (continued) Changing rooms - Effective flushing with filtered air - Separate rooms for entry and exit desirable Hand washing facilities Proper installation of pipes & ducts - Visual and/or audible warning system 5-Aug-11 9 OVERVIEW OF GMP

Equipment :

Equipment Use of automatic mechanical or electronic equipment Conveyer belts Effective sterilization of equipment Maintenance and repairs from outside the clean area - If taken apart, re-sterilized before use - Use clean instruments and tools 5-Aug-11 10 OVERVIEW OF GMP

Equipment (continued):

Equipment (continued) Planned maintenance, validation and monitoring (equipment, air filtration systems, sterilizers, water treatment systems) 5-Aug-11 11 OVERVIEW OF GMP

Environmental Monitoring - I:

Environmental Monitoring - I Microbiological Air samples Surface swabs Personnel swabs Ref: 5-Aug-11 12 OVERVIEW OF GMP

Environmental Monitoring – II :

Environmental Monitoring – II Physical Particulate matter Air changes, airflow patterns Filter integrity Temperature and relative humidity Airflow velocity Differential pressure 5-Aug-11 13 OVERVIEW OF GMP

Sanitation :

Sanitation Frequent, thorough cleaning of areas necessary Written programme Regular monitoring to detect resistant strains of microorganisms Chemical disinfection 5-Aug-11 14 OVERVIEW OF GMP

Sanitation (continued) :

Sanitation (continued) Monitoring of clean areas Monitoring of personnel and surfaces after critical operations Frequent monitoring in areas where aseptic operations are carried out - volumetric air samples, surface sampling (swabs and contact plates) - sampling methods should not contaminate the area 5-Aug-11 15 OVERVIEW OF GMP

Personnel :

Personnel Training of persons : - Quality & sterile product - Types of contamination - Sources of contamination - Environmental - Water - Raw material - Container & closures - Control of contamination - Training on sterilization 5-Aug-11 16 OVERVIEW OF GMP

Personnel (continued) :

Personnel (continued) Gowning & dress management - Non fiber shedding - Washing & sterilization - Head gear/ hood, face mask, one piece boiler suit, rubber/ plastic shoe, shoe cover, beard mask, safety goggles etc. 5-Aug-11 17 OVERVIEW OF GMP

Personnel (continued) :

Personnel (continued) Some specific requirements - Restrict number of people in aseptic area - Only trained person is allowed - Medical check up is more frequent - Person with psychological problem in working area should not allowed 5-Aug-11 18 OVERVIEW OF GMP

Personnel (continued) :

Personnel (continued) Minimum number of personnel in clean areas - especially during aseptic processing Inspections and controls from outside Training to all including cleaning and maintenance staff manufacturing, hygiene, microbiology 5-Aug-11 19 OVERVIEW OF GMP

Personnel (continued) :

Personnel (continued) High standards of hygiene and cleanliness Periodic health checks No shedding of particles No introduction of microbiological hazards Changing and washing procedure No watches, jewellery and cosmetics 5-Aug-11 20 OVERVIEW OF GMP

Possible Issues :

Possible Issues Poor design of the building Poor design of the systems, e.g. water, HVAC Flow of personnel Flow of material Old facilities not complying with current requirements Particulate levels/microorganism Temperature/humidity HEPA filters not checked regularly 5-Aug-11 21 OVERVIEW OF GMP

Two categories of manufacturing operations :

Two categories of manufacturing operations Terminally sterilized - prepared, filled and sterilized Aseptic preparation - some or all stages 5-Aug-11 22 OVERVIEW OF GMP

Manufacture of sterile preparations :

Manufacture of sterile preparations Classification of clean areas Manufacturing operation in an appropriate environment cleanliness level Minimize risks – particulate and microbiological contamination – product and material 5-Aug-11 23 OVERVIEW OF GMP

Manufacture of sterile preparations-II :

Manufacture of sterile preparations-II For sterile pharmaceutical preparations: Grade A - local zone, high risk operations, e.g. filling, aseptic connections Grade B - background environment to Grade A (in case of aseptic preparation and filling) Grade C and Grade D - Clean areas for less critical operations 5-Aug-11 24 OVERVIEW OF GMP

Processing :

Processing Minimize contamination - all stages including before sterilization and during processing No unsuitable materials, e.g. live micro organisms Minimize activities - staff movement - avoid shedding of particles Temperature and humidity comfortable Containers and materials in the area 5-Aug-11 25 OVERVIEW OF GMP

Processing (continued):

Processing (continued) Control of components : Storage, handling, sampling, testing & approved/ rejection of components & drug products Prohibit the use rejected material Each lot is identified as to its status & that material is stored separately Rejected material is handled separately 5-Aug-11 26 OVERVIEW OF GMP

Processing (continued) :

Processing (continued) Components, bulk product containers and equipment - fibre generation - no recontamination after final cleaning - sterilized when used in aseptic areas 5-Aug-11 27 OVERVIEW OF GMP

Processing (continued) :

Processing (continued) Time intervals: components, bulk container, equipment Washing , drying and sterilization - as short as possible - time limit validated Time intervals: product Start of preparation of solution and sterilization (filtration) - as short as possible - maximum time set for each product 5-Aug-11 28 OVERVIEW OF GMP

Sterilization :

Sterilization Methods of sterilization - moist or dry heat - irradiation (ionizing radiation) - sterilizing gaseous agents (e.g. ethylene oxide) - filtration with subsequent aseptic filling Whenever possible: terminal sterilization by heat in their final container - method of choice 5-Aug-11 29 OVERVIEW OF GMP

Sterilization (continued):

Sterilization (continued) Differentiation between sterilized and not-yet-sterilized products Each basket/tray or other carrier, properly labelled - name of material - batch number - sterilization status Sterilization records for each run – approved as part of the batch release procedure 5-Aug-11 30 OVERVIEW OF GMP

Terminal Sterilization:

Terminal Sterilization Sterilization by moist heat Sterilization by dry heat Sterilization by radiation Sterilization by gases 5-Aug-11 31 OVERVIEW OF GMP

Slide 32:

Sterilization by moist heat (heating in an autoclave ) Water - wettable materials only, and aqueous formulations Temperature, time and pressure monitored Independent temperature indicator Regular leak test Material allows for penetration of steam Quality of the steam – no contamination 5-Aug-11 32 OVERVIEW OF GMP

Slide 33:

Sterilization by dry heat For non-aqueous liquids, dry powders Air circulation in the chamber Positive pressure in chamber to prevent entry of non-sterile air HEPA filtered air supplied 5-Aug-11 33 OVERVIEW OF GMP

Slide 34:

Sterilization by radiation Suitable for heat-sensitive materials and products High radioactive isotope ( Cobalt – 60 γ - rays ) Mechanical acceleration of electrons ( cathode rays, β - rays ) 5-Aug-11 34 OVERVIEW OF GMP

Sterilization by Filtration :

Sterilization by Filtration Through a sterile filter of 0.22 µm or less, into previously sterilized containers - remove particles - remove bacteria and moulds Consider complementing with some degree of heat treatment Filter integrity testing immediately after use - also before use if possible 5-Aug-11 35 OVERVIEW OF GMP

Sterilization by Filtration - II:

Sterilization by Filtration - II Same filter not used for more than one working day, unless validated No filter interaction with product, e.g. - removal of ingredients - releasing substances into product 5-Aug-11 36 OVERVIEW OF GMP

Sterilization by gases:

Sterilization by gases Ethylene oxide ( EtO ): - Gas at room temperature - Highly flammable - Acts by alkylation of essential metabolites affecting particularly the reproductive process. 5-Aug-11 37 OVERVIEW OF GMP

Packaging & Labeling :

Packaging & Labeling Labeling error or product mix–ups are avoided Use of appropriate electronic equipment Visual inspection to conduct 100 % examination of labeling All the inspection is done by single person independently & verified by second person 5-Aug-11 38 OVERVIEW OF GMP

Finishing of products :

Finishing of products Containers closed by means of validated methods Samples checked for integrity Parenteral products inspected individually Visual inspection under suitable and controlled conditions 5-Aug-11 39 OVERVIEW OF GMP

Holding & Distribution:

Holding & Distribution Covers ware housing & distribution Covers the Q.C. unit Storage of drug products at appropriate condition System for documenting the distribution of each lot 5-Aug-11 40 OVERVIEW OF GMP


References Liberman H. A., Rieger M. M., Banker G., Pharmaceutical Dosages Forms Disperse System, Vol. 3 rd , Ed. 2 nd , (2005),Page no. 425-426. Potdar M. A., Pharmaceutical Quality Assurance, Nirali Prakashan,(2007), Page no. 13.1 to 13.60. Nigel H., Microbiological contamination Control In Pharmaceutical Clean Rooms, Sue Horwood Publishing,(2004) , Page no. 1-23. 5-Aug-11 41 OVERVIEW OF GMP

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4) Linna A. et al., Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer, European Journal of Pharmaceutics and Biopharmaceutics 69 (2008) 786–792. 5) Peyton T. H., Abdou O. A. Environmental Control Concepts for Industrial Clean-Room Facilities. Journal of Architectural Engineering. Vol. 1, No.1,(1995) 53-63. 5-Aug-11 42 OVERVIEW OF GMP

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