Back To Basic Gmp

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Back To Basic GMP

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<ul><li> WHAT IS GMP ? <ul><li>G OOD </li></ul><ul><li>M ANUFACTURING </li></ul><ul><li>P RACTICE </li></ul></li> <li> WHY DO WE NEED GMP? BAKIT KAILANGAN ANG GMP? </li> <li> TYPES OF CONTAMINATION <ul><li>PARTICULATES </li></ul><ul><li>MICROORGANISMS </li></ul><ul><li>CROSS-CONTAMINATION </li></ul></li> <li> TYPES OF CONTAMINANTS <ul><li>PARTICULATES </li></ul><ul><li>(Pira-pirasong bagay) </li></ul><ul><li>dust, dirt, paper, metal, fibers, etc. </li></ul><ul><li>MICROORGANISMS </li></ul><ul><li>(Mikrobyo) </li></ul><ul><li>bacteria, yeasts, molds </li></ul><ul><li>CROSS-CONTAMINATION </li></ul><ul><li>(Pag halo sa ibat-ibang produkto) </li></ul><ul><li><ul><li><ul><li>labels, cartons, foil, materials, etc. </li></ul></li></ul></li></ul></li> <li> SOURCES OF CONTAMINATION AIR , WATER, SURFACES,PEOPLE,PESTS </li> <li> <ul><li>IMPURE </li></ul><ul><li>UNCLEAN </li></ul><ul><li>UNFIT FOR USE </li></ul>CONTAMINATION PEOPLE CONTAMINATION CAUSE HEH! HEH! HEH! </li> <li> CGMP REGULATION <ul><li>Report any injury or illness immediately to your supervisor. </li></ul></li> <li> MICROORGANISMS CAN BE DESTROYED OR REDUCED BY: <ul><li>Personal Hygiene </li></ul><ul><li>Insect and pest control </li></ul><ul><li>Efficient &amp; effective plumbing </li></ul><ul><li>Clean and potable water </li></ul><ul><li>Correct cleaning &amp; sanitizing of equipment </li></ul><ul><li>Effective cleaning of processing areas, storage areas warehouse, etc. </li></ul></li> <li> CROSS - CONTAMINATION BUT IT WAS ONLY A FEW OUNCES a few ounces? THE WHOLE BATCH IS CONTAMINATED </li> <li> GMP. <ul><li>SHARED RESPONSIBILITY OF </li></ul><ul><li>ESTABLISHMENT AND EMPLOYEES </li></ul></li> <li> TO COMPLY WITH GMP Establishment provides Sufficient Space Physical Separation Adequate Lighting Adequate Ventilation Equipment, utensils Adequate facilities for every operations </li> <li> WORKERS AND EMPLOYEES Take necessary steps and follow procedures to assure sanitary and safe operation of the plant. </li> <li> HYGIENE AND SANITATION WHY IS HYGIENE AND SANITATION IMPORTANT? Man is a natural carrier of microorganisms. These are expelled when we SNEEZE (BUMAHIN ) COUGH (UMUBO) YAWN (HUMIKAB ) TALK (NAGSALITA ) </li> <li> MICROORGANISMS ARE IN MANS HAIR, SKIN, INTESTINES, URINE, UNDERNEATH FINGERNAILS. We collect more microorganisms as we travel from home to our destination due to dust, smoke generated by vehicles and contact with dirty items. It is therefore important that we observe good hygiene and sanitation to avoid contamination of products we handle. </li> <li> PLANT UNIFORM Cover street clothes that contain contaminants, organisms you collect on your way to the plant. Cover your exposed skin which sheds particles with germs. </li> <li> Cover the nose and mouth which are natural reservoir of germs. Trap particles or droplets from the nose and mouth. Cover your hair which have dust &amp; germs. Prevent hair from falling into the product. </li> <li> Cover finger nails and hands which have germs. Street shoes contain germs from the soil and dirt we stepped on, so it must not be worn inside the plant, plant shoes must be used instead. </li> <li> WHY USE RUBBER GLOVES??? It prevents microorganism transfer from our hands to the product we handle. It prevents transfer of product dust to our hands. </li> <li> It is porous and will not prevent transfer of microorganisms and perspiration to the product we handle. It permits transfer of product dust to our hands. WHY CANT WE USE COTTON GLOVES??? </li> <li> HANDLING OF GLOVES <ul><li>Place gloves in a clean plastic bag during break time. </li></ul><ul><li>2) Wash gloves with soap and water after use. Dry and sanitize. </li></ul></li> <li> 3) Change gloves for every product change. 4) Torn gloves or those with holes should not be used </li> <li> HYGIENE AND SANITATION PRACTICES <ul><li>*Wash hands with soap and water </li></ul><ul><li><ul><li>After using the toilet </li></ul></li></ul><ul><li><ul><li>Before starting to work </li></ul></li></ul><ul><li><ul><li>After blowing your nose </li></ul></li></ul><ul><li><ul><li>After handling dirty things </li></ul></li></ul><ul><li><ul><li>After touching body surface </li></ul></li></ul><ul><li><ul><li>After eating </li></ul></li></ul></li> <li> <ul><li>-Dont touch or scratch your nose, head, body parts while handling products. </li></ul><ul><li>-Cover your nose, mouth when sneezing, coughing, yawning. </li></ul><ul><li>-Avoid talking and use mask if necessary. </li></ul><ul><li>-Observe good toilet practices by: </li></ul><ul><li>- Flushing the toilet after use </li></ul><ul><li>-Washing hands with soap and water </li></ul></li> <li> HOW TO WASH YOUR HANDS </li> <li> <ul><li>Remove visible dirt. </li></ul>2. Rinse with water. </li> <li> <ul><li>3 . Wash with soap and water. </li></ul><ul><li>4. Rinse with water </li></ul></li> <li> <ul><li>5. Sanitize. </li></ul></li> <li> <ul><li>6. Dry hands. </li></ul></li> <li> GOOD HOUSE KEEPING PRACTICES <ul><li>- Keep dirt and dust away from work areas. Pick-up pieces of paper, foreign and unwanted objects that may be seen in the work area and throw them in the trash can. </li></ul><ul><li>-Clean up debris as work continuous. </li></ul><ul><li>-Do not place tools, materials, objects, etc. on product contact surfaces. </li></ul></li> <li> <ul><li>- When job is finished, clean up work area, surfaces and equipment. </li></ul><ul><li>-Keep personal things in the place provided for them. </li></ul><ul><li>-Place lunch wrappers, food left overs and other rabbish in the containers provided for them. </li></ul><ul><li>-Place soft drinks bottles in the container provided for them. </li></ul><ul><li>-Place chairs in orderly position before leaving the work area. </li></ul></li> <li> GMP IN THE WORK AREA <ul><li>Use the product container for the intended product only. Dont use it for glue, oil, soap, etc. </li></ul><ul><li>Be in your work assignment all the time. Dont attempt to transfer to adjacent packing lines to help as you may not be properly trained to do the job. </li></ul></li> <li> <ul><li>3. Clean up your debris as work continues. </li></ul><ul><li>4. Products falling on the floor or dirty surfaces must not be put back for packaging. </li></ul><ul><li>5. Cover product container and secure all materials pertaining to the product like labels, cartons, etc. before leaving the work area during break times. </li></ul><ul><li>6. Identify all containers used with product name, batch/lot number, expiry date. (Containers for rejects, unused labels, etc.) </li></ul></li> <li> <ul><li>7. Never handle products with bare hands. Use rubber gloves if you are assigned to handle products. </li></ul><ul><li>8. Clean and sanitize work area surface following instruction of supervisor when job is finished. </li></ul><ul><li>9. Dont touch nose, head or any body parts while handling products. </li></ul><ul><li>10. Dont get items from adjacent lines to be used in your line. </li></ul></li> <li> <ul><li>11) Cover your nose and mouth when sneezing or coughing. </li></ul><ul><li>12) Pay full attention to the assigned task and refrain from talking to your co-corkers. </li></ul><ul><li>13) Familiarize yourself with assigned operation taking note of distinct features to enable detection of mix-up or mistakes . </li></ul></li> <li> <ul><li>14) Follow strictly the instruction given by the supervisor. In case of doubt, seek the help of the supervisor. </li></ul><ul><li>15) Dont eat or chew gums while in the work area. </li></ul><ul><li>16) Notify supervisor promptly if there is an accidental contamination of product contact surfaces. </li></ul></li> <li> BACTERIA Bacilli Bacterial Spores Molds Pneumococci Yeast </li> <li> <ul><li>Mix-Ups and Errors too! </li></ul>Rushing a Job Cross-Contamination LOOK OUT!!! This is a RUSH job! may cause </li> <li> <ul><li>GOOD MANUFACTURING PRACTICE </li></ul><ul><li>-Developed in the 1960s </li></ul><ul><li>-Part of the Food, Drug, and Cosmetic act </li></ul><ul><li>-Has the force and effect of law </li></ul>THESE REGULATIONS HAVE THE FORCE AND EFFECT OF LAW CGMP Regulations </li> <li> BFAD IS RESPONSIBLE FOR SEEING THAT OUR COMPANY COMPLIES WITH CGMP REGULATIONS. </li> <li> IF WE HAVE NOT FOLLOWED CGMP REGULATIONS BFAD HAS THE AUTHORITY TO RECOMMEND RECALL </li> <li> HOW WE PURCHASE AND STORE RAW MATERIALS OUR BUILDING LABELLING &amp; PACKAGING THE PRODUCTION &amp; DISTRIBUTION OF OUR PRODUCTS OUR RECORDS OUR EQUIPMENT C G M P </li> <li> PREMISES <ul><li>Premises/building must be designed and constructed to facilitate company productivity, employee safety and product quality. </li></ul><ul><li>Plant site should be carefully selected considering the physical terrain and the ground surrounding it. </li></ul></li> <li> BUILDING PREMISES <ul><li>GMP REQUIREMENTS: </li></ul><ul><li>1. Separate area for specific operation. </li></ul><ul><li>2. Easy to clean. </li></ul><ul><li>3. Easy to maintain. </li></ul><ul><li>4. Easy to operate. </li></ul><ul><li>5. Adequate space </li></ul><ul><li>6. Eliminate unnecessary traffic </li></ul><ul><li>Inadequate space and unnecessary traffic cause mix-up and errors. </li></ul></li> <li> <ul><li>GMP REGULATION: </li></ul><ul><li> Defined area for </li></ul><ul><li>a. Receiving of materials </li></ul><ul><li>b. Storage of materials </li></ul><ul><li>c. Quality control laboratory </li></ul><ul><li>d. Manufacturing area </li></ul><ul><li>e. In-process storage </li></ul><ul><li>f. Packaging area </li></ul><ul><li>g. Quarantine area </li></ul></li> <li> GMP REGULATION -Light all Areas -Adequate for our needs -With back-up LIGHTING </li> <li> GMP REGULATION <ul><li>WATER SYSTEM </li></ul><ul><li>STEADY PRESSURE </li></ul><ul><li>FREE OF PROBLEMS </li></ul><ul><li>NO DRAINAGE BACK-FLOW </li></ul></li> <li> GMP REGULATION <ul><li>Waste materials must be removed and disposed of in a safe and sanitary manner. </li></ul></li> <li> GMP REGULATION <ul><li>Building must be maintained and kept in good condition. There must be a regular housekeeping . </li></ul></li> <li> <ul><li>Building must be protected from infiltration of contaminants and from outside elements like dust, odors, filth, pests. </li></ul><ul><li>Adequate space is necessary in designing a plant. </li></ul><ul><li>Adequate space is critical to the plant productivity, personnel safety and the quality of the product. </li></ul></li> <li> <ul><li>Lack of space can cause confusion in the workflow and this can adversely affect productivity. </li></ul><ul><li>Lack of space can also cause unnecessary traffic in the work area which can endanger employee safety. </li></ul><ul><li>Lack of space can result in contamination, mix-ups and errors. </li></ul></li> <li> PERSONNEL <ul><li>People should know how to perform the job right the first time and every time. </li></ul><ul><li>They must have the knowledge to perform their job and the skills required by the job. </li></ul><ul><li>People must have personal responsibility to develop personal competence. </li></ul></li> <li> <ul><li>That all of us receive training in the procedures relating to our job and in the cGMP regulations. </li></ul>Its a CGMP Regulation </li> <li> Proper Training in relation to their assigned task or function <ul><li>SOLUTIONS </li></ul><ul><li>IMPROVE INSPECTION METHODS </li></ul></li> <li> Engaged in supervision of manufacture processing, packing and holding of product <ul><li>Adequate number </li></ul><ul><li> to perform assigned task or function to give assurance of product quality, identity, purity. </li></ul>Sufficient Education Training Experience </li> <li> Engaged in manufacture, processing, packing and holding of product <ul><li>Adequate number </li></ul><ul><li> to perform assigned task or function </li></ul>Sufficient Education Training Experience </li> <li> <ul><li>TRAINED PERSONNEL=QUALITY PERFORMANCE </li></ul><ul><li> =CONTINUAL IMPROVEMENT </li></ul><ul><li>LESS PRONE TO ERRORS </li></ul><ul><li>LESS DEVIATIONS FROM STANDARDS </li></ul><ul><li>REDUCE AMOUNT OF REWORK </li></ul><ul><li>REDUCE AMOUNT OF REJECTS </li></ul></li> <li> TRAINING PROGRAM <ul><li>1. EACH INDIVIDUAL SHOULD HAVE A TRAINING PLAN. </li></ul><ul><li>2. COURSES AND TOPICS SHOULD BE LINKED TO THEIR CURRENT JOBS. </li></ul><ul><li>3. CONTENTS OF EACH COURSE SHOULD BE DOCUMENTED AND APPROVED BY MANAGEMENT. </li></ul><ul><li>4. PLAN FOR RETRAINING. </li></ul></li> <li> <ul><li>Confucius </li></ul><ul><li>I hear and I forget </li></ul><ul><li>I see and I remember </li></ul><ul><li>I do and I understand </li></ul></li> <li> PATTERN OF LEARNING AND REMEMBERING 83% by vision 50% of what we have heard and seen 11% by smelling 30% of what we have seen 3,5% by smell 20% of what we have heard 1,5% by skin senses 1% of what we read 1% by taste What we Remember What we learn </li> <li> <ul><li>KNOW YOUR COMPANY </li></ul><ul><li>- Its products, policies and services. </li></ul>READ COMPANY MANUAL </li> <li> <ul><li>REGULAR PHYSICAL EXAMINATION OR HEALTH CHECKS </li></ul></li> <li> <ul><li>PRACTICE GOOD SANITATION AND HEALTH HABITS </li></ul></li> <li> WEAR PROTECTIVE CLOTHING AS NECESSARY <ul><li>GOWN </li></ul><ul><li>GOGGLES </li></ul><ul><li>MASK </li></ul><ul><li>GLOVES </li></ul><ul><li>HEAD CAP </li></ul></li> <li> <ul><li>ADEQUATE PERSONAL RECORDS </li></ul><ul><li>Name </li></ul><ul><li>Address </li></ul><ul><li>Qualification </li></ul><ul><li>Signature </li></ul></li> <li> UNDERSTAND THE REQUIREMENTS And demands of your job. Determine how you can do your job most efficiently. </li> <li> FOLLOWING SOPS IS VITAL <ul><li> .AND SO ARE THE RECORDS WE KEEP! </li></ul><ul><li>SOPs </li></ul><ul><li>RECORDS </li></ul></li> <li> REASONS FOR WRITING PROCEDURES <ul><li>AVOID/MINIMIZE MIX-UPS AND ERRORS </li></ul><ul><li>ENSURE CONSISTENT QUALITY </li></ul><ul><li>ENSURE COMPLIANCE WITH GMP REGULATION </li></ul></li> <li> ACCURATE RECORD KEEPING IS VITAL . <ul><li>RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE THE JOB!!! </li></ul>When did I do. that? </li> <li> TRAINING MUST BE REINFORCED BY THE SUPERVISOR.. <ul><li>BFAD INSPECTORS ASK TO SEE OUR TRAINING RECORDS. </li></ul>FOLLOW S.O.P.s </li> <li> cGMP TRAINING MUST BE REINFORCED BY ON THE JOB SUPERVISION <ul><li>AND WHERE REQUIRED, SUPPLEMENTED BY A REVIEW TRAINING COURSE. </li></ul>FOLLOW SOPS!!! </li> <li> DEVELOPING COMPETENCE <ul><li>EDUCATION AND TRAINING </li></ul><ul><li>ON-THE-JOB EXPERIENCE </li></ul></li> <li> <ul><li>COMPETENCE </li></ul><ul><li>IS DEMONSTRATED BY SUCCESSFUL </li></ul><ul><li>JOB PERFORMANCE </li></ul></li> <li> DEFINITION OF COMPETENCE <ul><li>WEBSTER </li></ul><ul><li>1. Having ability or qualities </li></ul><ul><li>2. Legally qualified or able </li></ul><ul><li>DR. LAWRENCE J. PETER </li></ul><ul><li>(PETER PRINCIPLE) </li></ul><ul><li> COMPETENCE like truth, beauty and contact lenses, is in the eye of the beholder. </li></ul></li> <li> MEASURE OF COMPETENCE <ul><li>NUMBER OF SUCCESSES? </li></ul><ul><li>NUMBER OF FAILURES? </li></ul><ul><li>PROMPTNESS OF ACTION? </li></ul><ul><li>LEADTIME? </li></ul><ul><li>QUALITY OF ACTION? </li></ul></li> <li>...</li></ul>