GMP

Good Manufacturing Practices
By: Shweta Singh
The Early Beginnings

1900s house-calls Home remedies, ointments and miracle elixirs Entertainment and music No regulations until 1902
Fig. 1. Animation of ancient medicine show
Public Involvement
1905 - The Jungle by Upton Sinclair Exposure of unsanitary conditions in meat packing plants
Fig. 2. The Jungle by Upton Sinclair
Public awareness and involvement Pure Food and Drug Act False labeling became illegal
Fig. 3. 1906 Meat processing plant
What is GMP?
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.
Fig.4 GMP handbooks for every industry
What is GMP ?
GMP is that part of Quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use "GMP" - A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality.
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What is cGMP ?
Usually see cGMP where c = current, to emphasize that the expectations are dynamic
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Department of Pharmaceutics
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
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
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
Fig. 5 1906 Certificate of Purity signed by doctor
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 FDAs regulations regarding experimentation on humans and proposed new way how drugs are approved and regulated Proof of efficacy law
Fig 6. Kennedy signing the Kefauver Harris Drug Amendments
1976 Medical Device Amendments

1972 and 1973 Pacemaker failures reported 1975 - hearing-Dalkon Shield intrauterine device caused thousands of injuries Class I, II and III medical devices based on degree of control necessary to be safe and effective
Fig.7 President Gerald Ford signs the Medical Device Amendments
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
Fig.8 Parody on Infant Formula Act
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.
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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.
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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.
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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.
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.
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)
Part 211 Selected cGMP For Finished Pharmaceuticals

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.
..............
211.25 Personnel qualifications

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Good Manufacturing Practices (GMP) ensures quality assurance, compliance and good product development within the therapeutic goods industry. Graduate Certificate, Graduate Diploma or Master of Science (Good Manufacturing Practices). GMP courses are a joint initiative The GMP courses are designed for people currently working, or intending to work in the pharmaceutical or biotechnological sectors. Specialization in pharmaceuticals, biologics or medical devices http://www.gmptrainingsystems.com/?gclid=CKyi-tS1JUCFQM1gQod3m9cjg
GMP Training
GMP Training Products
In-Plant Training Programs

Interactive Computer-based GMP Training Web-based GMP Training Public Workshops GMP Implementation Resources http://www.gmptrainingsystems.com/PDF/Sample_Write _it_down_handout.pdf
Career Opportunities
International Quality Assurance Manager Senior Quality Assurance Manager Quality Assurance Associate - QA - (GMP) Pharmaceutical - Quality Manager GMP / GCP Manager Packaging Operator Line Service Operator
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!
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QA, GMP & QC inter-relationship

QA GMP
QC
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QA
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
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GMP
Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use
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QC 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 its quality
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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.
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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
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QC and QA
QC is lab based
QA is company based
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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
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
Department of Pharmaceutics 34
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GMP
Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears
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GMP
All past GMPs are history.It is looking like in rear view mirror and driving
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Ten Principles of GMP

1. Design and construct the facilities and equipments properly 2. Follow written procedures and Instructions 3. Document work 4. Validate work 5. Monitor facilities and equipment 6. Write step by step operating procedures and work on instructions 7. Design ,develop and demonstrate job competence 8. Protect against contamination 9. Control components and product related processes 10. Conduct planned and periodic audits
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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)
List of important documents in GMP

Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records
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Certifying agencies
ICH. www.ich.org WHO. www.who.int US FDA. www.fda.gov
EU/EMEA. www.emea.europa.eu
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How do GMPs of different countries compare?

At a high level, GMPs of various nations are very similar; most require things like: Equipment and facilities being properly designed, maintained, and cleaned Standard Operating Procedures (SOPs) be written and approved An independent Quality unit (like Quality Control and/or Quality Assurance) Well trained personnel and management
cGMP For Finished Pharmaceuticals

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 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
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General Provision
1. Scope 2. Definitions
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Organization & Personnel

1. Responsibilities of quality control unit. 2. Personnel qualifications. 3. Personnel responsibilities.
4. Consultants.
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Building & Facilities

1. Design and construction features. 2. Lighting. 3. Ventilation, air filtration, air heating and cooling. 4. Plumbing. 5. Sewage and refuse. 6. Washing and toilet facilities. 7. Sanitation. 8. Maintenance.
Equipment
1. 2. 3. 4. Equipment design, size, and location. Equipment construction. Equipment cleaning and maintenance. Automatic, mechanical, and electronic equipment. 5. Filters.
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Control of Components & Drug Product Containers & Closures

1. 2. 3. 4. 5. 6. 7. 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.
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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. 6. Time limitations on production. 7. Control of microbiological contamination. 8. Reprocessing. 1. 2. 3. 4. 5.
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Packaging & Labeling Control

1. 2. 3. 4. Materials examination and usage criteria. Labeling issuance. Packaging and labeling operations. Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 5. Drug product inspection. 6. Expiration dating.
Handling & Distribution

1. Warehousing procedures. 2. Distribution procedures.
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Laboratory Control
1. 2. 3. 4. 5. 6. 7. General requirements. Testing and release for distribution. Stability testing. Special testing requirements. Reserve samples. Laboratory animals. Penicillin contamination.
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Records & Reports

1. 2. 3. 4. 5. 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.
6.
7. 8. 9.
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Returned & Salvaged Drug Products

1. Returned drug products. 2. Drug product salvaging.
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References
Blackwell, John. 1906: Rumble Over The Jungle. 31 Aug. 2008. http://www.capitalcentury.com/1906.html FDA Food and Drug Administration. GMP Combination Handbooks. 31 Aug. 2008. http://images.google.com http://freepages.genealogy.rootsweb.ancestry.com/~myhadlfamily/hadl/hadlstories/phoeni17 .jpg The Center for Professional Advancement. Good Manufacturing Practice. 2008. 1 Sep. 2008. http://www.cfpa.com/gmp-training The Power of Story Telling. A Brief History of the GMPs. 2004. 31 Aug. 2008. http://immelresources.com/HistoryofGMPs.pdf The New York Times. 1906 Meat Processing Plant. 26 Jan. 2005. 31 Aug. 2008. http://www.nytimes.com/imagepages/2005/01/26/national/26meat.ready.html Torrent Pharmaceuticals Ltd. Pharmaceutical GMP: past, present, and futurea review. 2008. 31. Aug. 2008. http://www.atyponlink.com/GVR/doi/abs/10.1691/ph.2008.7319?cookieSet=1&journalCode=phmz
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GMP

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Good Manufacturing Practices

By: Shweta Singh

The Early Beginnings

Fig.4 GMP handbooks for every industry

Good Manufacturing Practices Worldwide Enforcement

In India by the Ministry of Health, multinational and/or foreign enterprises

A Time line of GMP

1941 Initiation of GMP

1962 Kefauver-Harris Drug Amendments

Fig 6. Kennedy signing the Kefauver Harris Drug Amendments

1976 Medical Device Amendments

1980 Infant Formula Act

Fig.8 Parody on Infant Formula Act

Good Manufacturing Practices

Some of the main risks are

Why GMP is important

GMP helps boost pharmaceutical export opportunities

21 CFR Part 820 (Medical Device Industry)

Part 211 Selected cGMP For Finished Pharmaceuticals

211.25 Personnel qualifications

In-Plant Training Programs

QA, GMP & QC inter-relationship

QA, GMP & QC inter-relationship

QA, GMP & QC inter-relationship

QA, GMP & QC inter-relationship

GMP as per WHO

GMP as per MCA now known as MHRA

GMP as per TGA

GMP as per US FDA

GMP as per ICH guidelines

Ten Principles of GMP

Cost of effective GMP

List of important documents in GMP

How do GMPs of different countries compare?

cGMP For Finished Pharmaceuticals

Organization & Personnel

Building & Facilities

Control of Components & Drug Product Containers & Closures

Production & Process Control

Packaging & Labeling Control

Handling & Distribution

Records & Reports

Returned & Salvaged Drug Products

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