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Good Manufacturing Practices (GMP and its implementation):

Good Manufacturing Practices (GMP and its implementation) By, Dr. Shreeraj Shah Associate Professor, Dept. of Pharmaceutical Technology, L. J. Institute of Pharmacy, Ahmedabad 7-Sep-12 1

What is GMP?:

Is a system to ensure consistency and control, and prevents or minimizes the risks involved in any pharmaceutical production or any other place where auditable/compliance data is handled. GMP’s are the Regulations that describe the minimum rules for the companies/pharmaceuticals to assure quality, security, purity, and effectiveness of the products. Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods. GMP’s are found in Title 21 Code of Federal Regulations Parts 210 and 211; they are applicable to products for human, veterinary, and/or biologic use. What is GMP? 7-Sep-12 2

cGMP’s – Historical Facts:

1202 – First reported case of bread adulteration (England). 1646 – Again, bread adulteration (Mass.). 1862 – Lincoln establishes the US Bureau of Chemistry. 1902 – The Biologics Control Act. 1 st federal law affecting domestic drugs Required licensing of serums and vaccines cGMP’s – Historical Facts 7-Sep-12 3

The Early Beginnings :

The Early Beginnings 1900s house-calls Home remedies, ointments and “miracle elixirs” Entertainment and music No regulations until 1902 Animation of ancient medicine show 7-Sep-12 4

Public Involvement:

Public Involvement 1905 - The Jungle by Upton Sinclair Exposure of unsanitary conditions in meat packing plants Public awareness and involvement Pure Food and Drug Act False labeling became illegal The Jungle by Upton Sinclair 1906 Meat processing plant 7-Sep-12 5

PowerPoint Presentation:

1906 – Food and Drug Act (the Act) which prohibits interstate shipping of: Misbranded products, Adulterated food, drinks and drugs. False claims not included in the Act. 1927 – The FDA is created. 1933 – Bill introduced to modify “the Act”. 7-Sep-12 6

cGMP’s – Historical Facts:

1937 – Sulfanilamide Elixir: Sulfanilamide – used against infections. Not available to children, only in tablet and powder. Liquid form created for children. Chemist formulates using diethylene glycol. 240 gallons supplied to market. Since no pharmacological studies were required: cGMP’s – Historical Facts 7-Sep-12 7

cGMP’s – Historical Facts:

1937 – Sulfanilamide Elixir: It was not known that diethylene glycol is a poison. It attacks the kidneys. Stops urination, Causes severe abdominal pain, nausea, Stupor and Convulsion, Death comes after 1-3 weeks. 107 people died, mostly children. cGMP’s – Historical Facts 7-Sep-12 8

cGMP’s – Historical Facts:

1938 – Food, Drug and Cosmetic Act: Regulates cosmetics and therapeutics, Fraud need not be proven only false claims, Scientific proof for safety , Regulations of additives (poisonous), Factory inspections are allowed cGMP’s – Historical Facts 7-Sep-12 9

cGMP’s – Historical Facts:

1941 – US vs. Dotterweich: Litigation established clear personal and individual responsibility for quality of products, This is regardless of knowledge or where manufactured. US vs. Park(CEO of Acme International) adds responsibility even if responsibility is delegated. Thus, responsibility for quality and compliance is a personal accountability. cGMP’s – Historical Facts 7-Sep-12 10

1941 Initiation of GMP:

1941 Initiation of GMP Sulfathiaziole tablets contaminated with phenobarbital 1941 - 300 people died/injured FDA to enforce and revise manufacturing and quality control requirements 1941 - GMP is born Certificate of Purity signed by doctor 7-Sep-12 11

cGMP’s – Historical Facts:

1958 to 1962 – Thalidomide Incident : Drug to treat sleep disorders and morning sickness (1 st trimester) in pregnant women. No prescription required in Europe. The Richardson-Merrell Co. submits in US. Frances Kelsey, reviewing chemist holds approval. By 1961 5,000 babies had born without limbs and other birth defects. cGMP’s – Historical Facts 7-Sep-12 12

1962 Kefauver-Harris Drug Amendments:

1962 Kefauver-Harris Drug Amendments Thalidomide tragedy Thousands of children born with birth defects due to adverse drug reactions of morning sickness pill taken by mothers Strengthen FDA’s regulations regarding experimentation on humans and proposed new way how drugs are approved and regulated “Proof of efficacy” law (required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval) Kennedy signing the Kefauver –Harris Drug Amendments 7-Sep-12 13

cGMP’s – Historical Facts:

1962 – Kefauver-Harris Amendment: Before marketing, firms must prove product to be safe and effective for intended use. Required patients be informed of what they are taking (experimental). During clinical trials, adverse effects must be reported to the FDA (Recently examples: Vioxx, Celebrex, etc.). Side effects must be listed, and generic name provided. cGMP’s – Historical Facts 7-Sep-12 14

1976 Medical Device Amendments :

1976 Medical Device Amendments 1972 and 1973 -Pacemaker failures reported 1975 - hearing-Dalkon Shield intrauterine device caused thousands of injuries Class I (elastic bandages, examination gloves, and hand-held surgical instruments), II (Powered wheelchairs, infusion pumps, and surgical drapes) and III-most regulated devices (implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators) medical devices – based on degree of control necessary to be safe and effective 7-Sep-12 15

1980 Infant Formula Act:

1980 Infant Formula Act 1978 - major manufacturer of infant formula reformulated two of its soy products 1979 - Infants diagnosed with hypochloremic metabolic alkalosis Greater regulatory control over the formulation and production of infant formula Modification of industry’s and FDA’s recall procedures Parody on Infant Formula Act 7-Sep-12 16

cGMP’s – Historical Facts:

1983 – Tamper Evident Packaging: Distraught wife ( Illinois) wants to murder husband. Buys several bottles of Tylenol capsules. Empties capsules and refills with NaCN and fish food. 3 people died, including husband. Investigation caused FDA to require tamper evident seals. cGMP’s – Historical Facts 7-Sep-12 17

cGMP’s – Historical Facts:

1985 to 1989 – Bolar, Vitarine and Dyazide: Both companies submit ANDA with SK&F product. Investigation paid by Mylan reveals cheating by Bolar and Vitarine, payoffs to FDA reviewing chemists, etc. Causes Generic Scandal of 1990. cGMP’s – Historical Facts 7-Sep-12 18

cGMP’s – Historical Facts:

1991 – US vs. Barr Laboratories: Among many issues, failure and OOS investigations are featured, The court provided explicit limitations on the use of outlier tests, The court ruled on the use of retesting, A successful resample result alone cannot invalidate an initial OOS result. cGMP’s – Historical Facts 7-Sep-12 19

A Time line of GMP :

A Time line of GMP 1902 - Development of the Biologic Control Act 1906 - Development of the Pure Food and Drug Act 1938 - Federal Food, Drug and Cosmetic Act 1941 - Initiation of GMP 1944 - Development of Public Health Services Act 1962 - Kefauver-Harris Drug Amendments released 1963 - Establishment of GMPs for Drugs 1975 - CGMPs for Blood and Components Final Rule 1976 - Medical Device Amendments 1978 - CGMPs for Drugs and Devices 1979 - GLPs Final Rule 1980 - Infant Formula Act is passed 7-Sep-12 20

Good Manufacturing Practices Worldwide Enforcement :

Good Manufacturing Practices Worldwide Enforcement Good Manufacturing Practices are enforced in the United States by the FDA In the United Kingdom by the Medicines and Healthcare Products Regulatory Agency GMPs are enforced in Australia by the Therapeutically Goods Administration In India by the Ministry of Health, multinational and/or foreign enterprises Many underdeveloped countries lack GMPs 7-Sep-12 21

PowerPoint Presentation:

7-Sep-12 22

PowerPoint Presentation:

Provisions 21 CFR Parts 210 and 211 (Drug Industry) 21 CFR Part 820 (Medical Device Industry) 21 CFR Part 110 (Food Industry) 21 CFR Part 606 (Blood Industry) 7-Sep-12 23

:

Subpart A-General Provisions Subpart B-Organization and Personnel 211.22 Responsibilities of quality control unit. 211.25 Personnel Qualifications. 211.28 Personnel responsibilities. Subpart C-Buildings and Facilities 211.46 Ventilation, air filtration, air heating and cooling. 211.58 Maintenance Subpart D-Equipment 211.63 Equipment design, size, and location. 211.65 Equipment construction. 211.67 Equipment cleaning and maintenance. 211.68 Automatic, mechanical, and electronic equipment. 211.72 Filters. Subpart E-Control of Components and Drug Product Containers and Closures 211.80 General requirements. 211.82 Receipt and storage of untested components, drug product containers, and closures. 211.84 Testing and approval or rejection of components, drug product containers, and closures. 211.86 Use of approved components, drug product containers, and closures. Subpart F-Production and Process Controls 211.100 Written procedures; deviations. 211.101 Charge-in of components. 211.103 Calculation of yield. 211.105 Equipment identification. Part 211 –Selected cGMP For Finished Pharmaceuticals 7-Sep-12 24

Good Manufacturing Practices:

Good Manufacturing Practices A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. 7-Sep-12 25

Some of the main risks are :

Some of the main risks are unexpected contamination of products, causing damage to health or even death. incorrect labels on containers, which could mean that patients receive the wrong medicine. insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. 7-Sep-12 26

Why GMP is important:

7-Sep-12 Why GMP is important A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect. 27

GMP helps boost pharmaceutical export opportunities:

7-Sep-12 GMP helps boost pharmaceutical export opportunities Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements. 28

GMP Covers…:

7-Sep-12 GMP Covers… ALL aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. 29

GMP:

7-Sep-12 GMP The Quality of a formulation or a bulk drug depends on the Quality of those producing it GMP is the magic key that opens the door of the Quality In matter of GMP, swim with the current and in matter of Quality stand like a rock! 30

QA, GMP & QC inter-relationship:

7-Sep-12 QA, GMP & QC inter-relationship QC GMP QA 31

QA, GMP & QC inter-relationship:

7-Sep-12 QA, GMP & QC inter-relationship It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use QA 32

QA, GMP & QC inter-relationship :

7-Sep-12 QA, GMP & QC inter-relationship Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use GMP 33

QA, GMP & QC inter-relationship:

7-Sep-12 QA, GMP & QC inter-relationship Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality QC 34

QC and QA:

7-Sep-12 QC and QA QC is that part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation,and release procedures which ensure that the necessary and relevant tests are carried out QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use. 35

QC and QA:

7-Sep-12 QC and QA Operational laboratory techniques and activities used to fulfill the requirement of Quality All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality 36

QC and QA:

7-Sep-12 QC and QA QC is lab based QA is company based 37

GMP guidelines:

7-Sep-12 GMP guidelines GMP as per Schedule “M” www.cdsco.nic.in GMP as per WHO www.who.int GMP as per MCA now known as MHRA www.mca.gov.uk GMP as per TGA www.tga.gov.au GMP as per US FDA www.fda.gov GMP as per ICH guidelines www.ich.org 38

GMP:

7-Sep-12 GMP GMP in solid dosage forms GMP in semisolid dosage forms GMP in Liquid orals GMP in Parenterals Production GMP in Ayurvedic medicines GMP in Bio technological products GMP in Nutraceuticals and cosmeceuticals GMP in Homeopathic medicines 39

GMP:

7-Sep-12 GMP Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears 40

Ten Principles of GMP:

7-Sep-12 Ten Principles of GMP Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits 41

Beyond GMP:

7-Sep-12 Beyond GMP Reduce pollution -  Zero discharge Adaptation of environment friendly methods Consideration for better and healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end 42

Cost of effective GMP:

7-Sep-12 Cost of effective GMP In fact Cost benefits – positive cost benefits of GMP/QA Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices Reduction in work in process and inventory holding costs Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation) 43

List of important documents in GMP:

7-Sep-12 List of important documents in GMP Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records 44

10 attributes of a good document:

7-Sep-12 10 attributes of a good document Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized 45

cGMP For Finished Pharmaceuticals:

7-Sep-12 cGMP For Finished Pharmaceuticals General Provision Organization & Personnel Building & Facilities Equipment Control of Components & Drug Product Containers & Closures Production & Process Control Packaging & Labeling Control Handling & Distribution Laboratory Control Records & Reports Returned & Salvaged Drugs 46

General Provision:

7-Sep-12 General Provision Scope Definitions 47

Organization & Personnel :

7-Sep-12 Organization & Personnel Responsibilities of quality control unit. Personnel qualifications. Personnel responsibilities . Consultants. 48

PERSONNEL:

PERSONNEL People should know how to perform the job right the first time and every time. They must have the knowledge to perform their job and the skills required by the job. People must have personal responsibility to develop personal competence. 7-Sep-12 49

PowerPoint Presentation:

That all of us receive training in the procedures relating to our job and in the cGMP regulations. It’s a CGMP Regulation 7-Sep-12 50

Proper Training in relation to their assigned task or function:

Proper Training in relation to their assigned task or function SOLUTIONS IMPROVE INSPECTION METHODS 7-Sep-12 51

Engaged in supervision of manufacture processing, packing and holding of product:

Engaged in supervision of manufacture processing, packing and holding of product Adequate number ……to perform assigned task or function to give assurance of product quality, identity, purity. Sufficient Education Training Experience 7-Sep-12 52

PowerPoint Presentation:

TRAINED PERSONNEL=QUALITY PERFORMANCE =CONTINUAL IMPROVEMENT LESS PRONE TO ERRORS LESS DEVIATIONS FROM STANDARDS REDUCE AMOUNT OF REWORK REDUCE AMOUNT OF REJECTS 7-Sep-12 53

TRAINING PROGRAM:

TRAINING PROGRAM 1. EACH INDIVIDUAL SHOULD HAVE A TRAINING PLAN. 2. COURSES AND TOPICS SHOULD BE LINKED TO THEIR CURRENT JOBS. 3. CONTENTS OF EACH COURSE SHOULD BE DOCUMENTED AND APPROVED BY MANAGEMENT. 4. PLAN FOR RETRAINING. 7-Sep-12 54

PATTERN OF LEARNING AND REMEMBERING:

PATTERN OF LEARNING AND REMEMBERING What we learn What we Remember 1% by taste 1% of what we read 1.5% by skin senses 20% of what we have heard 11% by smelling 30% of what we have seen 83% by vision 50% of what we have heard and seen 7-Sep-12 55

PowerPoint Presentation:

KNOW YOUR COMPANY - Its products, policies and services. READ COMPANY MANUAL 7-Sep-12 56

Building & Facilities:

7-Sep-12 Building & Facilities Design and construction features. Lighting. Ventilation, air filtration, air heating and cooling. Plumbing. Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance . 57

PREMISES:

PREMISES Premises/building must be designed and constructed to facilitate company productivity, employee safety and product quality. Plant site should be carefully selected considering the physical terrain and the ground surrounding it. 7-Sep-12 58

BUILDING PREMISES:

BUILDING PREMISES GMP REQUIREMENTS: 1. Separate area for specific operation. 2. Easy to clean. 3. Easy to maintain. 4. Easy to operate. 5. Adequate space 6. Eliminate unnecessary traffic Inadequate space and unnecessary traffic cause mix-up and errors. 7-Sep-12 59

PowerPoint Presentation:

GMP REGULATION: Defined area for a. Receiving of materials b. Storage of materials c. Quality control laboratory d. Manufacturing area e. In-process storage f. Packaging area g. Quarantine area 7-Sep-12 60

GMP REGULATION:

GMP REGULATION -Light all Areas -Adequate for our needs -With back-up LIGHTING 7-Sep-12 61

GMP REGULATION:

GMP REGULATION WATER SYSTEM STEADY PRESSURE FREE OF PROBLEMS NO DRAINAGE BACK-FLOW 7-Sep-12 62

GMP REGULATION:

GMP REGULATION Waste materials must be removed and disposed of in a safe and sanitary manner. 7-Sep-12 63

GMP REGULATION:

GMP REGULATION Building must be maintained and kept in good condition. There must be a regular housekeeping . 7-Sep-12 64

PowerPoint Presentation:

Building must be protected from infiltration of contaminants and from outside elements like dust, odors, filth, pests. Adequate space is necessary in designing a plant. Adequate space is critical to the plant productivity, personnel safety and the quality of the product. 7-Sep-12 65

PowerPoint Presentation:

Lack of space can cause confusion in the workflow and this can adversely affect productivity. Lack of space can also cause unnecessary traffic in the work area which can endanger employee safety. Lack of space can result in contamination, mix-ups and errors. 7-Sep-12 66

Equipment:

7-Sep-12 Equipment Equipment design, size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. Filters. 67

EQUIPMENT:

EQUIPMENT Equipment design must be carefully examined. Dedicated equipment should be used for products which are difficult to remove, difficult to clean and for products with a high safety risk. 7-Sep-12 68

EQUIPMENT:

EQUIPMENT REQUIREMENTS: MUST BE MADE OF MATERIALS THAT WILL NOT REACT WITH OR ABSORB ANY COMPONENTS THEY CONTACT. MUST BE DESIGNED FOR THE PARTICULAR PURPOSE FOR WHICH IT IS INTENDED. MUST BE LOCATED FOR EASY MAINTENANCE. SUBSTANCES USED FOR OPERATION LIKE LUBRICANTS, COOLANTS SHOULD NOT COME IN CONTACT WITH THE PRODUCT. 7-Sep-12 69

PowerPoint Presentation:

ALL MANUFACTURING EQUIPMENT NOT IN USE MUST BE STORED IN A MANNER TO KEEP IT CLEAN AND IN GOOD WORKING CONDITION. ALL EQUIPMENT MUST HAVE AN ACCURATE WELL DOCUMENTED LOG SHOWING WHAT WAS PRODUCED IN IT. ALL EQUIPMENT MUST HAVE A CLEANING LOG SHOWING WHEN, HOW AND BY WHOM EACH PIECE OF EQUIPMENT WAS CLEANED. ALL EQUIPMENT MUST HAVE AN IDENTIFICATION NUMBER WHICH SHOULD APPEAR ON THE BATCH RECORDS. 7-Sep-12 70

PowerPoint Presentation:

EQUIPMENT USED EXCLUSIVELY BY A PRODUCT, INDIVIDUAL LOG IS NOT REQUIRED. ALL EQUIPMENT MUST BE SANITIZED AFTER CLEANING. ALL EQUIPMENT MUST BE VALIDATED. EQUIPMENT MUST NOT BE USED AS STORAGE OF THINGS THAT DON’T BELONG TO THEM. 7-Sep-12 71

PowerPoint Presentation:

DETERGENTS USED FOR CLEANING MUST NOT BE SOURCE OF CONTAMINATION. MEASURING, WEIGHING, RECORDING AND CONTROL EQUIPMENT SHOULD BE CALIBRATED AND CHECKED AT DEFINED INTERVALS. MIXERS, PUMPS MUST HAVE CLEANABLE BEARINGS AND NON-LEAKING OIL SEALS. TANKS SHOULD HAVE COVED EDGES AND SLOPED BOTTOMS WITH THE OUTLET AT THE LOWEST POINT. 7-Sep-12 72

PowerPoint Presentation:

TANKS MUST HAVE DOMED TOP TO ALLOW CONDENSATION TO DRAIN BACK TO THE TANK. TANK VENTS AND OVERFLOW LINES SHOULD HAVE SCREEN TO PREVENT ENTRY OF PESTS. HOPPERS OF FILLING EQUIPMENT, RESERVOIRS MUST HAVE COVERS THAT ARE FIT AND EASY TO CLEAN. FIXED PIPEWORK MUST BE CLEARLY LABELED TO INDICATE CONTENTS AND DIRECTION OF FLOW. 7-Sep-12 73

PowerPoint Presentation:

ALL PIPE WORK MUST BE SLOPED SO THAT THEY WILL DRAIN AND TO AVOID LOW SPOT AND DEAD LEGS. INTERNAL WELDS MUST BE SMOOTH, NOT PITTED TO AVOID FLUX-CONTAMINATION. DUST EXTRACTORS MUST NOT LODGE POWDER IN THE DUCTING WHICH MAY FALL BACK INTO THE PRODUCT. DEFECTIVE EQUIPMENT SHOULD BE REMOVED IN THE PRODUCTION AREA, QC, ETC. AND CLEARLY LABELED AS DEFECTIVE. 7-Sep-12 74

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EQUIPMENT MUST BE LOCATED FOR EASY MAINTENANCE! 7-Sep-12 75

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Equipment should be designed for the particular purpose for which it is intended. This is an important CGMP Regulation! 7-Sep-12 76

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WHEN ? WHAT ? WHO ? EQUIPMENT LOG BOOK 7-Sep-12 77

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MAINTENANCE RETAIN EQUIPMENT IN ACCEPTABLE OPERATING CONDITION RESTORE EQUIPMENT TO AN ACCEPTABLE OPERATING CONDITION 7-Sep-12 78

PowerPoint Presentation:

IMPORTANCE OF MAINTENANCE REDUCE DOWNTIME 2. INCREASE PLANT AVAILABILITY 3. INCREASE EFFICIENCY 4.REDUCTION OF MANPOWER LEVEL 5.REDUCTION OF PRODUCTION COST 7-Sep-12 79

FACTORS TO CONSIDER IN DEVELOPING MAINTENANCE PROCEDURES:

FACTORS TO CONSIDER IN DEVELOPING MAINTENANCE PROCEDURES 1.RUN TIME IN OPERATING HOURS BEFORE MAINTENANCE. 2. SEVERITY OF USE 3. VIBRATION DATA 4. EXPECTED LIFE OF COMPONENTS. IT IS NOT ACCEPTABLE TO WAIT FOR A MACHINE TO BREAKDOWN BEFORE SERVICING IT. A CLEANED AND WELL MAINTAINED EQUIPMENT IS MORE RELIABLE AND PRODUCES LESS NON-CONFORMING PRODUCTS. 7-Sep-12 80

EQUIPMENT MAINTENANCE:

EQUIPMENT MAINTENANCE MECHANICAL AND PRECISION EQUIPMENT MUST BE CHECKED REGULARLY . ALL AUTOMATIC AND ELECTRONIC EQUIPMENT LIKE COMPUTERS MUST ALSO BE TESTED AND INSPECTED . 7-Sep-12 81

PowerPoint Presentation:

DATE ACTIVITY DATE STARTED DATE FINISHED SIGNATURE 1-16-09 MFG. RHEA ALC. BATCH 1234 1-16-09 1-17-09 1-18-09 CLEANING 1-18-09 1-18-09 1-19-09 MFG. RHEA ALCOLOGNE B#5 1-19-09 1-19-09 1-20-09 MIXER REPAIR 1-20-09 1-23-09 1-24-09 CLEANING 1-24-09 1-24-09 1-25-09 VALIDATION OF NEW MIXTURE 1-25-09 1-26-09 1-26-09 MFG. ALCOMFORADO B#1 1-26-09 1-27-09 SEQUENTIAL LOG NAME OF MACHINE: TAG NO: CAPACITY: 7-Sep-12 82

TYPES OF MAINTENANCE:

TYPES OF MAINTENANCE PREVENTIVE - ROUTINE - PLANNED CORRECTIVE - EMERGENCY - PLANNED MODIFICATION - PLANNED 7-Sep-12 83

MAINTENANCE RECORD:

MAINTENANCE RECORD 1. PROCEDURES AND SCHEDULES 2. CALIBRATION LOGS 3. EQUIPMENT LOGS 4. DOCUMENTATION OF MAINTENANCE CLEAN ENVIRONMENT + MAINTAINED EQUIPMENT = QUALITY PRODUCT 7-Sep-12 84

PowerPoint Presentation:

MAINTENANCE RECORD NAME OF EQUIPMENT: TAG NO. DATE INSTALLED: SUPPLIER: SERVICE JAN. FEB. MAR. APR. DONE NOT DONE REASON A . MONTHLY MAINTENANCE B. QUARTERLY MAINTENANCE SERVICE FIRST Q. SECOND Q. THIRD Q. FOURTH Q. DONE NOT DONE REASON 7-Sep-12 85

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YEARLY MAINTENANCE RECORD NAME OF EQUIPMENT: TAG NO. DATE INSTALLED : SUPPLIER: SERVICES 2006 2007 2008 2009 DONE NOT DONE REASON 7-Sep-12 86

REGULAR MAINTENANCE CHECKS…..:

REGULAR MAINTENANCE CHECKS….. ………..RECORDED ON PROPER FORMS!! Mechanical Equipment Precision Machines Automatic & Electronic Equipment & Computers 7-Sep-12 87

Control of Components & Drug Product Containers & Closures:

7-Sep-12 Control of Components & Drug Product Containers & Closures General requirements. Receipt & storage of untested components, drug product containers, and closures. Testing and approval or rejection of components, drug product containers, and closures. Use of approved components, drug product containers, and closures. Retesting of approved components, drug product containers, and closures. Rejected components, drug product containers, and closures. Drug product containers and closures. 88

COMPONENTS CONTROL:

COMPONENTS CONTROL Building quality into the product starts with components control. Source, origin and suitability of components should be clearly defined. Components should come from qualified or approved manufacturers. 7-Sep-12 89

COMPONENT:

COMPONENT Includes packaging materials as well as raw materials Any material intended for use in the manufacturing of our product 7-Sep-12 90

COMPONENTS:

COMPONENTS CORRECT SPECIFICATION + CORRECT MATERIALS = CORRECT PRODUCT We must control upon receipt and in use. Must come from approved suppliers. 7-Sep-12 91

ALL MATERIAL RECEIPT MUST BE:

ALL MATERIAL RECEIPT MUST BE IN GOOD CONDITION CLEAN AND IDENTIFIED Intact, no damage RAW MATL’S RAW MATL’S 7-Sep-12 92

All components must be sampled and tested by quality control……….:

All components must be sampled and tested by quality control………. ……to ensure that they conform to standards. All containers must be carefully resealed after each sample has been taken!!! 7-Sep-12 93

PowerPoint Presentation:

All new materials must be quarantined until approved for use……. All newly received materials must be: Properly identified and recorded Examined to make sure that each container is still tightly sealed Examined to make sure that each container is not damaged Examined to make sure there is no visible sign of contamination or impurity 7-Sep-12 94

PowerPoint Presentation:

GMP REQUIRES THAT COMPLETE RECORDS ARE KEPT ON ALL NEWLY RECEIVED COMPONENTS. Proper identification When received and inspected? Who did the inspection? Who took samples ? When were they tested? Who did the test? ????? 7-Sep-12 95

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And must be protected from damage by outside elements such as wind, rain and insects. It helps prevent mix-ups and errors!! All components must be stored in a safe and orderly way . . . 7-Sep-12 96

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After testing and examination by quality control ……. It may then be approved and released for manufacturing use ! APPROVED 7-Sep-12 97

COMPONENTS MUST BE PROTECTED FROM HARMFUL:

COMPONENTS MUST BE PROTECTED FROM HARMFUL BACTERIA 7-Sep-12 98

PowerPoint Presentation:

Reserve samples for every approved component….. Clearly identified Kept for at least one year after the expiration of the Product A rejected component must be properly identified and kept separate until it is disposed of. APPROVED APPROVED APPROVED REJECTED 7-Sep-12 99

COMPONENTS MUST BE USED IN PRODUCTION ON THE BASIS OF “FIRST IN – FIRST OUT”:

COMPONENTS MUST BE USED IN PRODUCTION ON THE BASIS OF “FIRST IN – FIRST OUT” …….an exception may be made if it is temporary and appropriate. Good!!! Makes Sense! 7-Sep-12 100

RAW MATERIALS:

RAW MATERIALS include both active and inactive are the ingredients that go into our products 7-Sep-12 101

EXCIPIENTS OR INACTIVE INGREDIENTS:

EXCIPIENTS OR INACTIVE INGREDIENTS Protects the product Covers up unpleasant odor Makes product look good Has no effect on the user 7-Sep-12 102

ACTIVE INGREDIENT:

ACTIVE INGREDIENT With direct effect on the user Makes the product effective 7-Sep-12 103

CERTIFICATE OF ANALYSIS:

CERTIFICATE OF ANALYSIS Maybe accepted if analytical competence has been established Typical analysis not accepted Full analysis is a must Equivalency of testing must be established for new supplier. Supplier must use same testing methods as the user. 7-Sep-12 104

PowerPoint Presentation:

BULK MATERIALS IT IS PERMISSIBLE TO MIX DELIVERIES OF A MATERIAL IN A SINGLE TANK PROVIDED: - THE TANK IS EMPTY AND CLEAN BEFORE THE FIRST DELIVERIES - ALL DELIVERIES ARE WITHIN SPECIFICATION BEFORE UNLOADING. - NONE OF THE MATERIAL IS USED UNTIL ALL OF THE DELIVERIES ARE ANALYZED - A SINGLE CONTROL NUMBER IS ASSIGNED TO THE ENTIRE TANK 7-Sep-12 105

PowerPoint Presentation:

COMPONENTS IN GOOD CONDITION, CLEAN AND IDENTIFIED INTACT, NO DAMAGE SAMPLED AND TESTED BY QC STORED IN A SAFE MANNER PROTECTED FROM WIND, RAIN, INSECTS WITH COMPLETE RECORDS COME FROM APPROVED SUPPLIERS FIRST IN-FIRST OUT OR FIRST EXPIRE-FIRST OUT RECONCILE USAGE 7-Sep-12 106

Production & Process Control:

7-Sep-12 Production & Process Control Written procedures; deviations . Charge-in of components. Calculation of yield. Equipment identification. Sampling and testing of in-process materials and drug products. Time limitations on production. Control of microbiological contamination. Reprocessing. 107

TYPES OF CONTAMINATION:

TYPES OF CONTAMINATION PARTICULATES MICROORGANISMS CROSS-CONTAMINATION 7-Sep-12 108

TYPES OF CONTAMINANTS:

TYPES OF CONTAMINANTS PARTICULATES dust, dirt, paper, metal, fibers, etc. MICROORGANISMS bacteria, yeasts, molds CROSS-CONTAMINATION labels, cartons, foil, materials, etc. 7-Sep-12 109

SOURCES OF CONTAMINATION:

SOURCES OF CONTAMINATION AIR , WATER, SURFACES,PEOPLE,PESTS 7-Sep-12 110

PowerPoint Presentation:

IMPURE UNCLEAN UNFIT FOR USE CONTAMINATION PEOPLE CONTAMINATION CAUSE HEH! HEH! HEH! 7-Sep-12 111

CGMP REGULATION:

CGMP REGULATION Report any injury or illness immediately to your supervisor. 7-Sep-12 112

MICROORGANISMS CAN BE DESTROYED OR REDUCED BY::

MICROORGANISMS CAN BE DESTROYED OR REDUCED BY: Personal Hygiene Insect and pest control Efficient & effective plumbing Clean and potable water Correct cleaning & sanitizing of equipment Effective cleaning of processing areas, storage areas warehouse, etc. 7-Sep-12 113

CROSS - CONTAMINATION:

CROSS - CONTAMINATION … BUT IT WAS ONLY A FEW OUNCES … a few ounces? THE WHOLE BATCH IS CONTAMINATED 7-Sep-12 114

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HYGIENE AND SANITATION WHY IS HYGIENE AND SANITATION IMPORTANT? Man is a natural carrier of microorganisms. These are expelled when we SNEEZE COUGH YAWN TALK 7-Sep-12 115

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MICROORGANISMS ARE IN MAN’S 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. 7-Sep-12 116

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Cover street clothes that contain contaminants, organisms you collect on your way to the plant. Cover your exposed skin which sheds particles with germs. PLANT UNIFORM 7-Sep-12 117

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Cover your hair which have dust & germs. Prevent hair from falling into the product. Cover the nose and mouth which are natural reservoir of germs. Trap particles or droplets from the nose and mouth. 7-Sep-12 118

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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. Cover finger nails and hands which have germs. 7-Sep-12 119

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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. 7-Sep-12 120

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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 CAN’T WE USE COTTON GLOVES??? 7-Sep-12 121

HANDLING OF GLOVES :

HANDLING OF GLOVES Place gloves in a clean plastic bag during break time. 2) Wash gloves with soap and water after use. Dry and sanitize. 7-Sep-12 122

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3) Change gloves for every product change. 4) Torn gloves or those with holes should not be used 7-Sep-12 123

HYGIENE AND SANITATION PRACTICES :

HYGIENE AND SANITATION PRACTICES *Wash hands with soap and water After using the toilet Before starting to work After blowing your nose After handling dirty things After touching body surface After eating 7-Sep-12 124

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-Don’t touch or scratch your nose, head, body parts while handling products. -Cover your nose, mouth when sneezing, coughing, yawning. -Avoid talking and use mask if necessary. -Observe good toilet practices by: - Flushing the toilet after use -Washing hands with soap and water 7-Sep-12 125

HOW TO WASH YOUR HANDS:

HOW TO WASH YOUR HANDS 7-Sep-12 126

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Remove visible dirt. 2. Rinse with water. 7-Sep-12 127

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3 . Wash with soap and water. 4. Rinse with water 7-Sep-12 128

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5. Sanitize. 7-Sep-12 129

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6. Dry hands. 7-Sep-12 130

GOOD HOUSE KEEPING PRACTICES :

GOOD HOUSE KEEPING PRACTICES - 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. -Clean up debris as work continuous. -Do not place tools, materials, objects, etc. on product contact surfaces. 7-Sep-12 131

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- When job is finished, clean up work area, surfaces and equipment. -Keep personal things in the place provided for them. -Place lunch wrappers, food left overs and other rubbish in the containers provided for them. -Place soft drinks bottles in the container provided for them. -Place chairs in orderly position before leaving the work area. 7-Sep-12 132

GMP IN THE WORK AREA :

GMP IN THE WORK AREA Use the product container for the intended product only. Don’t use it for glue, oil, soap, etc. Be in your work assignment all the time. Don’t attempt to transfer to adjacent packing lines to help as you may not be properly trained to do the job. 7-Sep-12 133

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3. Clean up your debris as work continues. 4. Products falling on the floor or dirty surfaces must not be put back for packaging. 5. Cover product container and secure all materials pertaining to the product like labels, cartons, etc. before leaving the work area during break times. 6. Identify all containers used with product name, batch/lot number, expiry date. (Containers for rejects, unused labels, etc.) 7-Sep-12 134

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7. Never handle products with bare hands. Use rubber gloves if you are assigned to handle products. 8. Clean and sanitize work area surface following instruction of supervisor when job is finished. 9. Don’t touch nose, head or any body parts while handling products. 10. Don’t get items from adjacent lines to be used in your line. 7-Sep-12 135

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11) Cover your nose and mouth when sneezing or coughing. 12) Pay full attention to the assigned task and refrain from talking to your co-corkers. 13) Familiarize yourself with assigned operation taking note of distinct features to enable detection of mix-up or mistakes . 7-Sep-12 136

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14) Follow strictly the instruction given by the supervisor. In case of doubt, seek the help of the supervisor. 15) Don’t eat or chew gums while in the work area. 16) Notify supervisor promptly if there is an accidental contamination of product contact surfaces. 7-Sep-12 137

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Mix-Ups and Errors too! Rushing a Job Cross-Contamination LOOK OUT!!! This is a RUSH job! may cause 7-Sep-12 138

Packaging & Labeling Control:

7-Sep-12 Packaging & Labeling Control Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. Drug product inspection. Expiration dating. 139

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PACKAGING MATERIALS Includes such Items as: Caps Bottles Labels Inserts Boxes Bags Wrappers Droppers Shippers Seal Plugs All the materials used in the packaging of a product 7-Sep-12 140

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STORAGE SIMILAR PRINTED MATERIALS SPATIALLY SEGREGATED IN ORDER TO PREVENT MIX-UP LABELS MUST BE STORED IN SEPARATE AREA TO PREVENT LABELS OF DIFFERENT PRODUCT, STRENGTH OR QUANTITIES BEING MIXED AND CAUSE ERROR IN PRODUCTION RETURNS FROM PACKAGING MUST BE CHECKED AND IDENTIFIED BEFORE RETURNING TO STOCK DAMAGED AND REJECTED MUST BE DESTROYED IN WAY THAT WILL MAKE THE MATERIAL UNUSABLE 7-Sep-12 141

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LABELS AND PRINTED MATERIALS SHOULD HAVE IDENTIFYING CODE NUMBER OR MARKS MUST BE CHECKED AGAINST A STANDARD OR ARTWORK UPON RECEIPT OBSOLETE MATERIALS MUST BE REMOVED FROM THE CONTROL SYSTEM AND INVENTORY SPECIMEN MUST BE SIGNED OFF BY QA TO INDICATE APPROVAL LIMITED ACCESS TO LABEL STORAGE LABELS AND PRINTED MATERIALS ISSUED ONLY WHEN AUTHORIZED KNOW NUMBER OF LABELS USED AND RECONCILE USAGE 7-Sep-12 142

Handling & Distribution :

7-Sep-12 Handling & Distribution Warehousing procedures. Distribution procedures. 143

Laboratory Control:

7-Sep-12 Laboratory Control General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contamination. 144

Records & Reports:

7-Sep-12 Records & Reports General requirements. Equipment cleaning and use log. Component, drug product container, closure, and labeling records. Master production and control records. Batch production and control records. Production record review. Laboratory records. Distribution records. Complaint files. 145

FOLLOWING SOP’S IS VITAL:

FOLLOWING SOP’S IS VITAL …….AND SO ARE THE RECORDS WE KEEP! SOP’s RECORDS 7-Sep-12 146

REASONS FOR WRITING PROCEDURES:

REASONS FOR WRITING PROCEDURES AVOID/MINIMIZE MIX-UPS AND ERRORS ENSURE CONSISTENT QUALITY ENSURE COMPLIANCE WITH GMP REGULATION 7-Sep-12 147

ACCURATE RECORD KEEPING IS VITAL …….:

ACCURATE RECORD KEEPING IS VITAL ……. RECORDS MUST BE FILLED OUT AT THE TIME WE COMPLETE THE JOB!!! When did I do…. that? 7-Sep-12 148

TRAINING MUST BE REINFORCED BY THE SUPERVISOR…..:

TRAINING MUST BE REINFORCED BY THE SUPERVISOR….. BFAD INSPECTORS ASK TO SEE OUR TRAINING RECORDS…. FOLLOW S.O.P.‘s 7-Sep-12 149

cGMP TRAINING MUST BE REINFORCED BY ON THE JOB SUPERVISION:

cGMP TRAINING MUST BE REINFORCED BY ON THE JOB SUPERVISION AND WHERE REQUIRED, SUPPLEMENTED BY A REVIEW TRAINING COURSE. FOLLOW SOP’S!!! 7-Sep-12 150

PRODUCTION DOCUMENTS:

PRODUCTION DOCUMENTS PRODUCTION DOCUMENTS ARE THE BLUEPRINTS WE FOLLOW WHEN WE PRODUCE A PRODUCT. PRODUCTION DOCUMENTS SHOULD BE WRITTEN WITH DETAILED STEPS IN A CLEAR AND LOGICAL MANNER TO ACHIEVE SAFE AND EFFECTIVE PRODUCT. ASSURES PERFORMANCE OF THE SAME JOB THE SAME WAY EACH TIME. 7-Sep-12 151

MASTER PRODUCTION RECORDS:

MASTER PRODUCTION RECORDS MASTER FORMULA TO ASSURE UNIFORMITY FROM BATCH TO BATCH SHALL BE PREPARED BY ONE PERSON, DATED AND SIGNED(FULLSIGNATURE,HANDWRITTEN)AND INDEPENDENTLY CHECKED, DATED AND SIGNED BY A SECOND PERSON. 7-Sep-12 152

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SHALL INCLUDE: NAME AND STRENGTH OF THE PRODUCT NAME AND WEIGHT OR MEASURE OF EACH ACTIVE INGREDIENT PER DOSAGE UNIT AND A STATEMENT OF THE TOTAL WEIGHT OR MEASURE OF ANY DOSAGE FORM. COMPLETE LIST OF COMPONENTS WITH CODES AN ACCURATE STATEMENT OF WEIGHT OR MEASURE OF EACH COMPONENT USING THE SAME WEIGHT SYSTEM STATEMENT ON CALCULATED EXCESS OF COMPONENT STATEMENT OF THEORETICAL WEIGHT OR MEASURE AT ANY STAGE OF PROCESING 7-Sep-12 153

MASTER MANUFACTURING PROCEDURE:

MASTER MANUFACTURING PROCEDURE 1.STATE THE PROCESSING LOCATION AND THE PRINCIPAL EQUIPMENT TO BE USED. 2.STATE THE METHODS OR REFERENCE TO THE METHODS TO BE USED FOR PREPARING THE EQUIPMENT 3.DETAILED STEPWISE PROCESSING INSTRUCTIONS: CHECKS ON MATERIALS, PRE-TREATMENT ,ASSEMBLING, SEQUENCE OF ADDING MATERIALS, MIXING TIME, SPEED, TEMPERATURE 7-Sep-12 154

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INSTRUCTION FOR IN-PROCESS CONTROLS STATE STORAGE CONDITION, INCLUDING THE CONTAINER TO BE USED, LABELLING, ETC. PROVISION FOR SIGNATURES AND CHECKS FOR EACH STEP OF PROCESSING SPECIAL PRECAUTIONS STATE MINIMUM AND MAXIMUM PRECENTAGES OF THEORETICAL YIELD, BEYOND WHICH INVESTIGATION IS CARRIED OUT. IDENTIFICATION OF THE PERSONS PERFORMING DIRECTLY, SUPERVISING OR CHECKING EACH SIGNIFICANT STEP. 7-Sep-12 155

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PACKAGING INSTRUCTIONS MUST BE PREPARED FOR EACH PRODUCT, PACK SIZE AND TYPE. SHALL INCLUDE: 1.NAME OF PRODUCT 2.STRENGTH AND DESCRIPTION OF THE PRODUCT 3.PACK SIZE EXPRESSED IN TERMS OF NUMBER OR WEIGHT OR VOLUME OF THE FINAL PRODUCT IN THE CONTAINER 4.COMPLETE LIST OF ALL PACKAGING MATERIALS REQUIRED FOR A STANDARD BATCH SIZE, INCLUDING QUANTITIES, SIZES, TYPES, WITH CODES OR REFERENCE NUMBER RELATING TO THE SPECIFICATION OF THE MATERIAL 7-Sep-12 156

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5 . A STATEMENT WHERE TO INDICATE LOT NUMBER AND EXPIRY DATE 6. SPECIAL PRECAUTIONS 7. DESCRIPTION OF THE PACKAGING OPERATION AND EQUIPMENT TO BE USED 8. DETAILS OF IN-PROCESS CONTROLS AND SAMPLING AND ACCEPTANCE LIMITS 9. DESCRIPTION OF THE PRODUCT CONTAINER AND CLOSURE 10. YIELD AND PERCENTAGE OF THEORETICAL YIELD 7-Sep-12 157

DISPENSING:

DISPENSING REQUIREMENTS: RAW MATERIALS MUST BE APPROVED BY Q.C. MUST BE THE LOT NUMBER SPECIFIED IN MO. MUST NOT SHOW EVIDENCE OF TAMPERING OR DETERIORATION. CONTAINERS NEW PLASTIC OR PE BAG. FOR LIQUIDS, STAINLESS STEEL CONTAINER WITH COVER. MUST BE CLEANED, SANITIZED AND DRIED. 7-Sep-12 158

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C. BALANCE MUST BE CALIBRATED MUST BE CLEANED MUST BE SENSITIVE ENOUGH FOR THE AMOUNT BEING WEIGHED. D. WEIGHING TOOLS SCOOPS MUST BE STAINLESS STEEL. MUST BE CLEANED, SANITIZED AND DRIED BEFORE USE. ONE MATERIAL PER SCOOP; TO BE CLEANED BEFORE USE FOR OTHER MATERIAL. E. WEIGHING BRING IN ONE MATERIAL AT A TIME (CLEAN THE CONTAINER OUTSIDE ) ZERO THE BALANCE TARE THE CONTAINER AND RECORD THE WEIGHT. 7-Sep-12 159

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SCOOP THE REQUIRED AMOUNT OF THE MATERIAL TO THE TARED CONTAINER SLOWLY AND RECORD THE GROSS WEIGHT. CLOSE THE MATERIAL, INNER BAG AND DRUM. RETURN MATERIAL TO STORAGE. DISPENSED MATERIAL REMOVE ENTRAPPED AIR, TWIST THE OPEN END, FOLD AND TIE WITH TWISTER WIRE OR RUBBER BAND ATTACH WEIGHING LABEL. PLACE IN A CONTAINER LINED WITH CLEAN PE BAG TOGETHER WITH THE OTHER MATERIALS FOR ONE BATCH 7-Sep-12 160

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DISPENSING ATTIRE LONG GOWN MASK CAP GLOVES OTHERS WEIGHING LABELS MUST BE IN DUPLICATE; THE ORIGINAL ATTACHED TO THE IMMEDIATE CONTAINER OF THE MATERIAL DISPENSED AND THE DUPLICATE ATTACHED TO THE JOB ORDER FOR POSTING OF MATERIAL USAGE. QUANTITY OF MATERIALS WITH ASSAY MUST BE ADJUSTED TO 100%; CHECKED BY QC OR A RESPONSIBLE PERSON. NO DOWNWARD ADJUSTMENT IS ALLOWED. DISPENSED MATERIALS MUST BE USED IMMEDIATELY. 7-Sep-12 161

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QUALITY MATERIALS + QUALITY PROCESSING = QUALITY PRODUCTS Processing system …..we produce well designed and quality correctly operated….. products every time 7-Sep-12 162

DOCUMENTS REQUIRED FOR PRODUCTION:

DOCUMENTS REQUIRED FOR PRODUCTION MANUFACTURING MONOGRAPH “RECIPE” 2. BATCH RECORD “WHAT” 3. CONTROL MONOGRAPH “TESTS” 4. “SOP’s” 7-Sep-12 163

BATCH PRODUCTION RECORDS MUST BE CAREFULLY FOLLOWED AND MONITORED…..:

BATCH PRODUCTION RECORDS MUST BE CAREFULLY FOLLOWED AND MONITORED….. ……..THROUGHOUT THE PRODUCTION PROCESS BATCH PRODUCTION RECORD QUALITY CONTROL MANUFACTURING 7-Sep-12 164

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Manufacturing Monograph Control Monograph Batch Record SOP’s … They tell us what and how to produce our products 7-Sep-12 165

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No one changes the SOP’s… Manufacturing and Control Monographs ...until it has been approved by the heads of Manufacturing and Quality Control 7-Sep-12 166

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Each step is spelled out in detail Sample Batch Record STEP --------------- --------------- ---------------- RESPONSIBLE FOR STEP Mary Jones DATE Sept. 15, 2008 Person Responsible for step 7-Sep-12 167

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1. Instruction 2. Training guideline 3. Reference / checklist 4. Control 5. Reviewer 6. Record FUNCTIONS OF WRITTEN PROCEDURE 7-Sep-12 168

MANUFACTURING AND PACKAGING:

MANUFACTURING AND PACKAGING MANUFACTURING AND PACKAGING OPERATION IS THE FINAL STEP OF BUILDING QUALITY INTO THE PRODUCT. IN THESE OPERATION WE MUST PRECLUDE POTENTIAL MIX-UPS AND ERRORS AND CONTAMINATION. PROCEDURES MUST BE STRICTLY FOLLOWED AND EFFECTIVE CONTROLS SHOULD BE IN PLACE. IN-PROCESS CHECKS MUST BE CARRIED OUT AT SPECIFIC TIME INTERVALS TO MONITOR GMP COMPLIANCE 7-Sep-12 169

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TWO STEPS MUST BE DONE BEFORE ANY MANUFACTURING BEGINS . STEP 1. ASSIGNMENT OF THE LOT NUMBER TO THE PRODUCT TO BE MANUFACTURED. This number will identify that particular product throughout manufacturing 7-Sep-12 170

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THIS LOT NUMBER IS THE KEY TO THE RECORDED HISTORY OF THE: MANUFACTURING PROCESSING PACKAGING HOLDING AND DISTRIBUTION OF THE PRODUCT 7-Sep-12 171

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LOT NUMBER is the specific identification assigned to each individual lot …….. We call it the “lot number” We call it the “batch number” We call it the “control number” We call it… 7-Sep-12 172

BATCH:

BATCH Specific quantity of a drug or other material, intended to have Uniform character and quality within specific limits Produced according to a Single manufacturing order During the same cycle of manufacture 7-Sep-12 173

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The lot number remains with the batch from start to finish Must appear on the .. label shelf carton shipping carton From start to finish 7-Sep-12 174

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During manufacturing, in-process testing is done by Quality Control to make sure that the product meets the specifications in the batch Production Records. ….and SOP’s have been followed and recorded where required . Quality Control 7-Sep-12 175

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At any point, adjustments to bring the batch up to specifications may be made according to the SOP’s. …And we have to approve it. 7-Sep-12 176

COMPLAINTS:

COMPLAINTS ALL COMPLAINTS AND OTHER INFORMATION CONCERNING POTENTIALLY DEFECTIVE PRODUCT MUST BE CAREFULLY REVIEWED AND INVESTIGATED ACCORDING TO WRITTEN PROCEDURES. 7-Sep-12 177

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Records of complaints and results of investigation must be kept… ……for at least one year after the expiry date or according to policy 7-Sep-12 178

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Any complaints of a product is automatically Investigated. The entire Batch Production Record and Batch Control Record must be reviewed. 7-Sep-12 179

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THE SOURCE AND CONTENT OF DEFICIENCIES, REMEDIAL MEASURES TAKEN AND TESTS PERFORMED SHOULD BE DOCUMENTED IN WRITING AND ADDED TO THE BATCH RECORDS. CONSIDERATION SHOULD BE GIVEN TO CHECK IF OTHER BATCHES COULD BE AFFECTED AND TO CEASE SUPPLY UNTIL THE PROBLEM IS FULLY INVESTIGATED. PRODUCT RECALL SHOULD BE INITIATED IF DEFICIENCY IS POTENTIALLY HARMFUL TO HEALTH. 7-Sep-12 180

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Nature of Complaint Name and Address Product of person complaining Name Result of investigation and follow-up its strength Lot Number If no investigation… reason why and the name of the person making the decision Reply Record of complaint 7-Sep-12 181

Returned & Salvaged Drug Products:

7-Sep-12 Returned & Salvaged Drug Products Returned drug products. Drug product salvaging. 182

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THE PROGRESS OF RECALL SHOULD BE RECORDED. A FINAL REPORT SHOULD BE ISSUED, INCLUDING RECONCILIATION BETWEEN THE DELIVERED AND RECOVERED QUANTITIES OF THE QUESTIONABLE PRODUCT. 7-Sep-12 183

STABILITY PROGRAM:

STABILITY PROGRAM THE STABILITY OF PRODUCTS SHOULD BE MONITORED ACCORDING TO A CONTINUOUS APPROPRIATE PROGRAM THAT WILL PERMIT DETECTION OF ANY INSTABILITY ASSOCIATED WITH THE FORMULATION IN THE MARKETED PACKAGE. 7-Sep-12 184

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THE ON GOING OR REAL TIME STABILITY PROGRAM AIMS TO MONITOR THE PRODUCT OVER ITS SHELF LIFE AND TO DETERMINE IF THE PRODUCT REMAINS OR CAN BE EXPECTED TO REMAIN WITHIN SPECIFICATION UNDER THE LABELLED STORAGE CONDITIONS. 7-Sep-12 185

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