This document provides an overview of the history and development of Good Manufacturing Practices (GMP) regulations. It discusses key events that shaped GMP standards, including unsanitary meat packing conditions exposed in 1905, the sulfathiazole tablet contamination incident in 1941 that resulted in the formal adoption of GMP, and other drug and medical device issues in subsequent decades. The document also outlines GMP requirements regarding facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, records, and other areas. Overall, it traces how GMP evolved from early 1900s to modern standards to ensure consistency and quality in pharmaceutical manufacturing.

1. Good Manufacturing
Practices
Neeraj Shrivastava
Quality Assurance Team

2. The Early Beginning
1. 1900s house-calls
2. Home remedies,
ointments and “miracle
elixirs”
3. Entertainment and music
4. No regulations until 1902
Fig. 1. Animation of ancient medicine show
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3. 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.
Fig. 2. The Jungle by Upton Sinclair
Fig. 3. 1906 Meat processing plant6/12/2016 3

4. 1941 Initiation of GMP
Sulfathiaziole Tablets
• Contaminated with
phenobarbital.
• About - 300 people
died/injured.
• FDA to enforce and
revise manufacturing and
quality control
requirements. Fig. 4 1906 Certificate of Purity signed by
doctor
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5. 1941 - GMP is born
• The beginning of modern standards for
good manufacturing practices can be
traced to an incident that began in
December 1940, when the Winthrop
Chemical Company of New York put on
the market sulfathiazole tablets
contaminated with Phenobarbital.
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6. 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. Fig 5. Kennedy signing the Kefauver –
Harris Drug Amendments
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7. Images of Thalidomide tragedy
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8. 1976 Medical Device
Amendments
•1972 and 1973 -
Pacemaker failures
reported
•1975 - hearing-Dalkon
Shield intrauterine
device caused
thousands of injuries
Fig.6 President Gerald Ford signs the
Medical Device Amendments6/12/2016 8

9. 1976 Medical Device
Amendments
• Class I, II and III
medical devices –
based on degree of
control necessary to
be safe and effective.
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10. 1980 Infant Formula Act
•1978 - major
manufacturer of infant
formula reformulated
two of its soy products
•1979 - Infants
diagnosed with
hypochloremic
metabolic alkalosis.
Fig.8 Parody on Infant Formula Act
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11. 1980 Infant Formula Act
• Greater regulatory control over the
formulation and production of infant
formula
• Modification of industry’s and FDA’s
recall procedures
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12. History
FOOD AND DRUGS ACT
1. FOOD AND DRUG REGULATIONS
DIVISION 2 : GOOD MANUFACTURING PRACTICES
2. 1900’S- ADULTERATED FOOD
FIRST PURITY LAWS ENACTED
3. 1930’S- SULFANILIMIDE
DRUGS HAD TO BE PROVEN SAFE
4. 1960’S- THALIDOMIDE
DRUGS HAD TO BE PROVEN SAFE AND EFFECTIVE
THROUGH CLINICAL TRIALS
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13. GMP Agencies Worldwide Enforcement
• In US :- USFDA : United States Food and
Drug Administration.
• In UK :- MHRA : Medicines and Healthcare
Products Regulatory Agency.
• In Australia :-TGA : Therapeutic Good
Administration.
• In India :-
FDA : The Ministry of Health, Food and
drug Administration.follow Schedule-M
Part of Drug & Cosmetic Act 1945.
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14. Introduction to cGMP
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15. cGMP Legal Principles
• Current = dynamic
–Standards evolve over time current, to
emphasize that the expectations are
dynamic.
• Good practices
–Minimal standards
–Not “best practices”
• Unless “best” is, in fact, current minimal
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16. Objectives GMP Training
Acquire basic knowledge of current
Good Manufacturing Practices
(cGMP).
1. Good Manufacturing Practices.
2. Contamination.
3. General Employee Hygiene.
4. Food Handling Practices.
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17. What are GMPs..?
GMP is that part of Quality assurance which
ensures that the products are consistently
manufactured and controlled to the desired
Quality standards appropriate for intended use
"GMP" - A set of principles and procedures
which, followed by manufacturers for
therapeutic goods, helps ensure that the
products manufactured the required quality.
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18. Why are cGMPs important?
• GOVERNMENT REQUIREMENT.
• ENSURE QUALITY PRODUCT.
• REDUCE REJECTS, RECALLS.
• SATISFIED CUSTOMERS.
• MAINTAIN MANUFACTURING
CONSISTENCY.
• COMPANY IMAGE AND REPUTATION.
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19. Good Manufacturing Practices
DEAL WITH CONTAMINATION:-
•BY PEOPLE
•BY FOOD MATERIALS
•BY PACKAGING MATERIALS
•BY HAZARDOUS MATERIALS
•BY MISCELLANEOUS MATERIALS
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20. Hygiene
All employees working in direct contact
with food, food contact surfaces and
food packaging must conform to
hygienic practices. This protects against
food contamination by microorganisms
or unwanted material.
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21. Prevent contamination
Careless employee practices can
cause product contamination.
The best way to avoid
contamination is to prevent it.
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22. Any behavior that could result
in food contamination such as
eating, use of tobacco, chewing
gum or other unhygienic
practices, is not allowed in
manufacturing & packing areas.
How do we prevent
contamination?
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23. Hygiene & Communicable Diseases
• Clothing
• Hair
• Personal habits
• Hand washing
• Personal effects
and jewelry.
• Illness and
disease
• Injuries
• Visitors
• Training.
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24. Production employees
- Bathe daily.
- No perfume, aftershave, fragrant
creams.
- No jewellery.
- No false nails or nail polish.
- Fingernails should be trimmed short.
- Use metal detectable bandages
covered with gloves.
- No eating, drinking or chewing gum.
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25. Clothing
- Everyone must wear pants and
covered sleeves.
- Separate shoes (no open toes or
high heels) are to be worn in the
factory.
- Personal belongings and street
clothing must be stored in locker
rooms.
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26. Illness
• Doctor’s certificate on hiring
• Inform your supervisor or HR if you
are ill with symptoms that could
contaminate ingredients or products.
• No medication allowed in factory.
• Ensure that a clean bandage covers
any open wounds.
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27. Hand washing
All employees must wash their hands
thoroughly:
• When they enter food handling areas
• Before starting work.
• After handling contaminated materials
• After breaks.
• After using toilet facilities.
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28. Personnel
- Do not leave gloves, masks, etc. lying
around while on break or at shift end.
- Crates, boxes, containers or buckets
must not be placed directly on the
floor.
- Store brooms and dust pans at
stations Provided.
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29. Product
- Keep hand contact with ingredients
to a minimum.
- Check ingredients for expiration
dates to ensure that fresh
ingredients are used.
- Cooling product should always be
kept covered.
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30. Equipment and containers
- Return tools and attachments to
their proper place after use.
- Check product surfaces before
starting equipment. Remove any
foreign objects or dirt.
- Replace brushes that lose bristles.
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31. GMP Categories
•SALES
•PREMISES
•EQUIPMENT
•PERSONNEL
•SANITATION
•RAW MATERIAL
TESTING
•MANUFACTURING
CONTROL
•QUALITY CONTROL
DEPARTMENT
•PACKAGING MATERIAL
TESTING
•FINISHED PRODUCT
TESTING
•RECORDS
•SAMPLES
•STABILITY

32. Sales
•NO DISTRIBUTOR … AND NO
IMPORTER SHALL SELL A DRUG
UNLESS IT HAS BEEN FABRICATED,
PACKAGED/LABELED, TESTED, AND
STORED IN ACCORDANCE WITH THE
REQUIREMENTS OF THIS DIVISION.
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33. Premises & Equipments
• Permits effective
cleaning.
• Prevents contamination.
• Orderly conditions.
• Good state of repair.
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34. LOCATION AND SURROUNDINGS
• Environmentally polluted areas and industrial
activities which produce disagreeable or
obnoxious odour, fumes, excessive soot,
dust, smoke, chemical or biological emissions
and pollutants, and which pose a serious
threat of contaminating food,
• Areas subject to flooding,
• Areas prone to infestations of pests, and
areas where wastes, either solid or liquid,
cannot be removed effectively.
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35. Personnel
• Appropriate education, training and
experience.
• Sufficient number of people
• Receive cGMP training
–Initial and continuing training as
relevant to job responsibilities.
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36. Sanitation
• Sanitation Program to prevent contamination
• Cleaning procedures for facilities & equipment
• Pest control.
• Environmental monitoring.
• Documented evidence.
• Keep contact surfaces clean and free of
contamination from tools, cords, cleaning
utensils, machine parts, lubricants and paper.
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37. Sanitation
• Keep everything off the floor and area clean
and floors swept.
• Work areas should be cleaned regularly
throughout the shift.
• Keep your immediate working area swept or
dust mopped. Wipe or mop up spilled liquids
promptly.
• Scrape the floor around the work area after
completing a job.
• Leave your work area clean at the end of your
shift.
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38. Sanitation
• Hygiene
1. Health and eye examinations.
2. Report adverse health conditions.
3. Clothing requirements
• No direct skin contact with product.
• Wash hands.
• No jewelry or excessive makeup.
4. No smoking, eating, drinking, chewing, or
keeping of plants in operations areas.
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39. Raw Material Testing
• Each lot or batch of raw material is tested to
–confirm the identity of the raw materials.
–provide assurance that quality of the drug
in dosage form will not be altered by raw
material defects.
–assure that raw materials have the
characteristics that will provide the
desired quantity or yield in
manufacturing process.
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40. RM, PM and Finished Product Testing
• Samples of incoming materials are
collected and tested before use.
• Approved test methods and
specifications are used.
• Results must conform to specifications
for release for use or sale.
• Transportation and storage records.
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41. Manufacturing Control
• Written procedures are established
and followed.
–Master formulae, manufacturing
order and packaging order.
• Critical processes are validated.
• 2nd person verification of activities.
• Quarantine system.
• Labelling requirements.
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42. Manufacturing Control
• Recall Programme
• Self-Inspection Programme
• Ensure compliance with vendors
/contractors.
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43. Manufacturing Control (cont’d)
• Validation: the documented act of
demonstrating that any procedure, process,
equipment, material, activity, or system will
consistently lead to the expected results.
–Design Qualification (DQ)
–Installation Qualification (IQ)
–Operational Qualification (OQ)
–Performance Qualification (PQ)
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44. Quality Control Department
• Quality Control Responsibilities
–Testing of bulk components prior to
use by production.
–Testing of finished product prior to
release for sale.
–Stability program (in association with
QA).
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45. Samples and Stability
• Samples
–Retain samples of each lot of raw
material and finished product for
specified period of time.
• Stability
–Establish the length of time in
which the product meets all
specifications.
–Monitor the drug for this period
of time.
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46. Quality Assurance
• Wide-ranging concept
–covers all matters that individually or
collectively influence the quality of a
product.
• Totality of the arrangements
–to ensure that the drug is continuously of
the right quality for the intended use.
• Quality Assurance incorporates GMP
–and also includes product design and
development, with special focus on
process design.

47. Quality Assurance Department
• Quality Assurance Responsibilities
–Ensure cGMP compliance.
–Review batch records, labels.
–Release product, based on QC test results.
–Authorize all master documents and SOPs.
–Training, auditing.
–Handling customer complaints.
–Recall.
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48. Key Quality Terms
• CHANGE CONTROL
–Written procedure that describes the
action to be taken if a change is
proposed to facilities, etc. used in
fabrication, packaging, and testing of
drugs or any change that may affect
quality or support system operation.
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49. Key Quality Terms
• DEVIATION
–Planned or unplanned temporary
departure from an approved
process, specification or
procedure with the potential to
impact product quality.
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50. Records
• Document all cGMP activities.
• Use Good Documentation
Practices (GDP).
• Records must be readily
available.
• Needed to prove activities
were done.
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51. Good Documentation Practices
• Documentation must be:
–Permanent (blue ink)
–Legible, clear, concise.
–Accurate.
–Timely.
–Consistent.
–Complete.
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52. Our Goals
Safety: Product is free of unwanted side effects
when used appropriately by patient.
Identity: Product exactly matches the labeling
and related documents.
Purity: Product is free from contamination.
Strength: Product has correct concentration,
potency or therapeutic activity of active
ingredient.
Quality: Product meets all standards,
expectations; performs as claimed and product
made consistently.
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53. Summary
1. PHARMACEUTICAL INDUSTRY IS REGULATED
BY GMP AND IT MUST BE FOLLOWED.
2. GMP’S ENSURE DRUG PRODUCTS ARE SAFE,
PURE AND EFFECTIVE.
3. QUALITY SHOULD BE BUILT INTO THE
PRODUCT.
4. GMP'S ARE VERY SIMILAR AND ARE REALLY
GOOD COMMON SENSE.
5. GOOD PRACTICES COVER ALL ASPECTS OF
MANUFACTURING ACTIVITIES PRIOR TO
SUPPLY.
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54. Thank you..