1. fundamentals of c gmp for young pharmaceutical professional presentation no. 1

Fundamentals of cGMP
Basic Training Guide to Young
Pharmaceutical Professionals
Prepared By: Muhammad Amir Javed
0092 344 2184236

INTRODUCTION
• This Presentation belongs to young pharmaceutical professionals who
just enter in the field of pharmaceutical industry, specially in the field
of Quality Assurance-Inspection Site and Production.
• cGMP exists in every section and every department of Pharmaceutical
Industry.
• Those pharmaceutical professionals who pursue their career in this
field should remember the basic principles of cGMP.

• To prevent “contamination and
cross-contamination”
• To prevent “mix-ups”
cGMP – Basic AIM

cGMP – OUTCOME
• Product;
a. QUALITY
b. SAFETY
c. EFFICACY

BASIC FUNDAMENTALS OF cGMP
• cGMP stands for “current Good Manufacturing Practices”
• Below are the fundamentals of cGMP;
1. Personnel
2. Material
3. Machine
4. Method
5. Premises
6. Documentation
7. Personnel Protective Equipments (PPEs)

1. PERSONNEL – What should remember???
• Type of Personnel,
1. Personnel as a part of “MANAGEMENT”
2. Personnel as a part of “EMPLOYEES”

1. Personnel as a part of “MANAGEMENT”
a. CEO
b. Directors
c. Managing Directors

2. Personnel as a part of “EMPLOYEES”
a. Departmental Heads
b. Managers
c. Assistant Managers
d. Section Incharges
e. Executives
f. Officers
g. Workers
h. Cleaners
i. Sweepers

1. PERSONNEL – What cGMP aspects???
• Job Descriptions (JD’s)
• Training records
• Orientation Plan
• Medical Examination
• Personnel Hygiene and Health
• Necessary Qualification
• Implement effective Pharmaceutical
Quality System
• Visitors and Untrained personnel first
give training before entering in
production areas

• KEY PERSONNEL
1. Head of Quality Control
2. Head of Production
3. Authorize Person
4. Head of Quality Assurance

• PERSONNEL HYGIENE
a. Detail Hygiene Programs
b. Medical Examination
c. No person affected to infectious
diseases and open lesions
d. Use of respective PPEs in all
departments
e. Avoid direct contact with exposed
products or any equipment part
where product contact

2. MATERIALS – What cGMP aspects???
• Handling of correct materials
• Types of Materials;
1. Materials related to Production
2. Materials related to Quality Control

1. TYPES OF MATERIALS RELATED TO
PRODUCTION
Raw Materials (Excipients and APIs) /
Starting Materials
Intermediate and Bulks
Packaging Materials
Finish Products
Rejected, Recovered and Returned
Materials

1. TYPES OF MATERIALS RELATED TO PRODUCTION-General Considerations
Proper Storage Condition
Labeled as Quarantine, Sampled, Released or Rejected
Proper labeling and identification
No damage container
Checks on yields and reconciliation
Prevents risks of mix-ups and cross contamination upon handling
Protects from Physical, Chemical and Microbial contamination
Precautions will be taken if any material is sensitizing, highly active or light
sensitive

1. TYPES OF MATERIALS RELATED TO QUALITY CONTROL
Organic Solvents (Acetone, Methanol, IPA, Acetonitrile etc)
Inorganic Chemicals
Reference Standards
Laboratory Reagents
Culture Media

3. MACHINES – What cGMP aspects???
TYPES OF MACHINES
1. Production Equipments
2. Quality Control Equipments
3. Inprocess Control Equipments

3. MACHINES – TYPES OF MACHINES???
a. Sterile Area Equipments
b. Non Sterile Area Equipments
c. Packaging Equipments

General Examples:
i. Liquid Filling Machines
ii. Powder Filling Machines
iii. Blenders
iv. Fluid Bed Dryers
v. Autoclave
vi. Dryers
vii. Primary Materials Washing Machines
viii. Printing Machines
ix. Cartoner Machines

2. Quality Control Equipments
i. High Performance Liquid Chromatography
ii. Spectrophotometer
iii. Gas Chromatography
iv. Atomic Absorption
v. Amino Acid Analyzer
vi. Dissolution Apparatus
vii. Karl Fisher
viii. TDS Meter
ix. Conductivity Meter

3. Inprocess Control Equipments
i. Disintegration Tester
ii. Hardness Tester
iii. Moisture Analyzer
iv. Weighing Balance
v. Friability tester
vi. Leak Test Apparatus
vii. Auto Thickness and Diameters
apparatus
viii. Cylinders for volumetric analysis

1. Production Equipments-General Considerations
Prevents cross contamination
Stainless steel made (specially product exposure parts)
Corrosion Free
No damage parts
Properly Qualified (DQ, IQ, OQ, PQ)
Dedicated Equipments to be used
Corrective and Preventive maintenance schedule

1. Production Equipments-General Considerations
Easily and thoroughly clean
Non hazardous to products
Appropriate range and precision
Peripheral accessories associated with the Equipments should be labelled
properly
Properly documented
Training Record
Respective SOPs

2. Quality Control and In-Process
Control Equipments-General
Considerations
CFR Compliance
Corrosion Free
No damage parts
Properly Qualified (DQ, IQ, OQ, PQ)
Corrective and Preventive
maintenance schedule
Easily and thoroughly clean

2. Quality Control and In-Process Control
Equipments-General Considerations
Appropriate range and precision
Peripheral accessories associated with the
Equipments should be labelled properly
Properly documented
Training Record
Respective SOPs

4. METHODS – What cGMP aspects???
3 types of methods related to product concern
1. Methods relating to Manufacturing
2. Methods relating to Analytical testing
3. Methods relating to Product packing

Following product category are
produced by various manufacturing
methods
a. Starting Materials (APIs and
Excipients)
b. Sterile Products (Injectables,
Biologicals etc)
c. Non Sterile Products (Tablet,
Capsule, Suspension, Liquid etc)

General consideration for different methods;
Blending
Granulation
Compression
Coating
Mixing

2. Methods relating to Analytical Testing
Following Testing Methods are performed
on below mentioned materials to ensure
product strength, efficacy and purity
a. Raw Materials
b. Intermediate Bulks
c. Finish Products
d. Packaging Materials

General consideration for different testing methods on Finish
Products;
Physical Testing
(Appearance, Length, Thickness, Hardness, Volume, pH etc)
Chemical Testing
(Assay, Dissolution, Content Uniformity, Impurity testing etc)
Microbiological Testing
(Microbial Limit Test, Sterility Test, Endotoxin Test, Bioassay etc)

General consideration for different testing methods on Raw
Materials;
Physical Testing
(Appearance, Tap density, Bulk density, pH, ROI etc)
Chemical Testing
(Identification test, Assay, Iron, Lead, Impurity testing etc)
Microbiological Testing
(Microbial Limit Test, Sterility Test, Endotoxin Test, Bioassay
etc)

General consideration for different testing
methods on Packaging Materials;
I. Primary Packaging
II. Secondary Packaging
III. Tertiary Packaging
Tests includes (Grammage, art work,
color, fonts, thickness, weight, Glass test
etc)

5. PREMISES– What cGMP aspects???
• Located, design, constructed, adapted and maintained to suit the
operations to be carried out.
• Layout and design must minimize to risk errors, permit effective
cleaning, maintenance
• Avoid cross contamination and mix-ups
• do not present any hazard to the quality of products
• Lighting, temperature, humidity and ventilation should be
appropriate
• maximum protection against the entry of insects or other animals
• prevent the entry of unauthorised people

• Types of Premises;
I. Production Areas
II. Storage Areas
III. Dispensing and Sampling Areas
IV. Quality Control Areas
V. Ancillary Area

i. Production Areas
• Generalized areas
• Dedicated areas
• Self contained areas
• Logical Order flows
• Logical placement of Equipments
• Adequacy of working space

i. Production Areas
• free from cracks and open joints, and should
not shed particulate matter
• should permit easy and effective cleaning and
disinfection
• Pipe work, light fittings, ventilation points and
other services should not create any recesses
• Drains should be of adequate size, and have
trapped gullies
• areas should be effectively ventilated air control
facilities (including temperature and, where
necessary, humidity and filtration)

ii. Storage Areas
• sufficient capacity to allow orderly storage of the various categories of materials
and products: starting and packaging materials, intermediate, bulk and finished
products, products in quarantine, released, rejected, returned or recalled.
• Maintain Temperature and where required humidity, should be monitored and
checked
• Materials should be cleaned where necessary before storage
• access restricted to authorized personnel
• Highly active materials or products should be stored in safe and secure areas
• Printed packaging materials: safe and secure storage of these materials

iii. Dispensing and Sampling Areas
• There should normally be a separate sampling and dispensing area for
starting materials
• prevent contamination or cross-contamination

iv. Quality Control Areas
• separated from production areas
• Sufficient space should be given to avoid mix-ups and cross-
contamination
• Separate rooms: protect sensitive instruments from vibration,
electrical interference, humidity, etc
• Special requirements: biological or radioactive samples

v. Ancillary Areas
• Rest and refreshment rooms
• Maintenance workshops
• Animal houses
• Toilets
• Should be separated

6. DOCUMENTATION– What cGMP aspects???
• Essential part of Quality Assurance system
• Compliance with GMP requirements
• Manufacturer’s Quality Management System
• Documentation: Paper Based, Electronic based or Photographic
Media
• Two main types of Documentation
1. Procedures / Instructions
2. Records / Reports

1. Procedure / Instructions
I. Site Master File
II. Specifications
III. Master Formula
IV. Processing instruction
V. Packaging Instruction
VI. Testing Instructions
VII. Procedures
VIII. Protocols
IX. Technical Agreements

Required GMP Documentation (By Type)
2. Records / Reports
I. Records
II. Certificate of Analysis
III. Reports

GOOD DOCUMENTATION PRACTICES
• Handwritten entries should be
made in clear, legible, indelible
way
• Records should be made or
completed at the time each action
and must be traceable
• document should be signed and
dated, where alteration happens

7. PERSONNEL PROTECTIVE
EQUIPMENTS (PPEs)

7. Personnel Protective Equipment (PPEs)–
What cGMP aspects???
a. Sterile Area PPEs
b. Non Sterile Area PPEs
c. Ancillary Area PPEs

a. STERILE AREA PPES

b. NON STERILE AREA PPES

c. Ancillary Areas PPEs

1. fundamentals of c gmp for young pharmaceutical professional presentation no. 1

1. fundamentals of c gmp for young pharmaceutical professional presentation no. 1

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