CGMP REGULATIONS

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CGMP REGULATIONS

• BASICS OF CGMP AND FUNCTIONS OF FDA

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CGMP TRAINING

• This program has been designed to encourage your
  active participation
• Your participation will make learning more
  interesting.

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HOW TRAINING WORKS

• We will give you inputs.
• Listen and follow pictorials in your workbook
• When told, write in information or complete a
  progress check.

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HOW TRAINING WORKS

• Progress checks make sure that you fully
  understand what you have heard.
• No one grades your progress checks.
• Writing the correct answers will help you learn
  and remember.

Idea
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GMP ORIENTATION

1. Introduction
2. Quality Management
3. Terminology
4. Premises
5. Equipment
6. Personnel
7. Sanitation Hygiene
8. Material Testing

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Introduction

• Purpose of GMP
• Good Manufacturing Practice (GMP) regulations
  were introduced as a means to ensure that a given
  product is processed reliably, repeatedly,
  consistently, safely and to a high quality.
• In the pharmaceutical processing industry GMP
  is an essential part of the production process.

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Introduction

• Why GMP is established?
• Just prior to start of the 2nd World War there
  was a serious poisoning incident in the USA. This
  prompted the introduction of the Food, Drugs and
  Cosmetics Act 1938, by US Food and Drugs
  Administration (FDA). The intention of the new
  act was to ensure that food, drugs, cosmetics and
  biological products were safe for human contact.
• Hence the need to establish Good Manufacturing
  Practice (GMP).

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Introduction

• The Indian Government made Current Good
  Manufacturing Practice (Schedule M) part of

Drug Cosmetic Act in 1940
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Manufacturing Guidelines
Current Good Manufacturing Practice
Regulations
cGMPs
FDA
Entrepreneur
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Why cGMP Training
Why is it necessary to Participate
in this cGMP Training Program
When We All Follow the SOPs?
When we carefully follow each step of our SOPs
we are also complying with the cGMP regulations!
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cGMP training must be reinforced by on-the-job
supervision
Now thats a Reinforcement
Follow the SOPs
and where required supplemented by a review
training course.
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I follow SOPs Sir
Thats Good. Be an example to others.
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DOCUMENTATION

• Specifications describe in details the
  requirements with which the products or
  materials used or obtain during the
  manufacture have to conform. They serve as a
  basis for quality evaluation
• Manufacturing formulae, Processing and
  packing instructions state all the starting
  materials used and lay down all processing and
  packaging operations
• Procedures give directions for performing
  certain operations e.g. cleaning, clothing,
  environmental control, sampling, testing,
  equipment operation.

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Validation
DQ, IQ, OQ and PQ

• Design user or process requirements
• Install installation qualification
• Operate operational qualification
• Validate performance qualification and
  process validation
• Review periodically ( change control)

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This V-Model figure shows how links the URS,
Functional Specification, Design Qualification
and the Testing Qualifications (IQ, OQ, PQ)  
 
User Requirement Specification
Performance Qualification
Functional Specification
Operational Qualification
Design Qualification
Installation Qualification
Installation
Flow chart
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Water system design (2) 1. Ball valves are
unacceptable
2. Bacteria can grow when the valve is closed
3. The water is contaminated as it passes through
the valve
Stagnant water inside valve
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TQM

• TQM incorporates the concepts of
• product quality
• process control
• quality assurance and
• quality improvement
• It is the control of all transformation processes
  of an organization to better satisfy customer
  needs in the most economical way.
• Total quality management is based on internal or
  self-control, which is embedded in each unit of
  the work system (technology and people). Pushing
  problem solving and decision-making down in the
  organization allows people who do the work to
  both measure and take corrective action in order
  to deliver a product or service that meets the
  needs of their customer.

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SQC SPC

• Statistical Process Control (SPC) is a method of
  monitoring, controlling and, ideally, improving a
  process through statistical analysis.
• Its four basic steps include
• measuring the process,
• eliminating variances in the process to make it
  consistent,
• monitoring the process, and
• improving the process to its best target value.