The document discusses the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA for the herbal drug industry, ensuring proper design and control of manufacturing processes. It outlines key systems such as quality management, production, laboratory control, material, packaging, and equipment that are crucial for maintaining drug safety and quality. Overall, CGMP aims to prevent contamination and errors, ensuring drug products meet regulatory standards.

1. Quality Control & Standardization Of
Herbals
Current Good Manufacturing Practice
(cGMP)
By
Kaushal Kumar

2. TABLE OF CONTENTS
01 02 03 04
Introduction Objective Relationship Guidelines

3. cGMP refers to the Current Good Manufacturing Practice
regulations imposed by the FDA.
cGMP assures proper design, monitoring and control of
manufacturing processes and facilities in the herbal drug
industry.
It also includes establishing strong quality management
systems, obtaining the right quality of raw materials,
establishing robust operating procedures, detecting and
investigating product quality and maintaining reliable testing
laboratories.
It helps to prevent contamination, mix-ups, deviations, failures
and errors.
Thus, assures that drug products meet the Current Good
Manufacturing Practice regulations.
INTRODUCTION

4. →cGMP regulations assure that quality is built into the design and manufacturing
process at every step.
→ Manufacturing facilities are in good condition.
→ Equipment's are properly maintained and calibrated.
→ Employees are qualified and fully trained.
→ Processes that are reliable and reproducible.
Objective Of cGMP

5. Guidelines On cGMP
Production
System
Facilities &
Equipment
Systems
Packaging &
Labelling System
Laboratory Control
System
Material System
The FDA’s drug manufacturing inspection compliance program contains instructions to FDA
personnel for conducting inspections, is a systems-based approach to inspection and is
very consistent with the robust quality system model presented in this guidance.
Relationship between six system :

6. Quality System
Every pharmaceutical product has to establish identity, strength, purity and other
quality characteristics to ensure the required levels of safety and effectiveness. It
includes all product defect evaluations and evaluation of returned and salvaged
drug products.
Production System
This system includes measures and activities to control the manufacture of drugs
and drug products including batch compounding, dosage form production, in-
process sampling and testing and process validation. It also includes establishing,
following and documenting the performance of approved manufacturing
procedures.
Guidelines On cGMP

7. Facilities & Equipment System
This includes the measures and activities which provide a proper physical
environment and resources used in the production of the drugs or drug products.
It includes:
→ Buildings and facilities along with maintenance.
→ Equipment qualifications (installation and operation).
→ Equipment calibration and preventative maintenance.
→ Cleaning and validation of cleaning processes.
Laboratory Control System
This system includes measures and activities related to laboratory procedures,
testing, analytical methods development and validation or verification, and the
stability program.
Guidelines On cGMP

8. Material System
It includes measures and activities to control finished products, components
including water or gases that are incorporated into the product, containers and
closures. It also includes validation of computerized inventory control, processes,
drug Storage, distribution controls and records.
Packaging and Labelling System
This system includes measures and activities that control the packaging and
labeling of drugs and drug products. It includes written procedures, label
examination and usage, label storage and issuance, packaging and labeling
operations controls and validation of these operations.
Guidelines On cGMP

9. THANKS!
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