PHARMACEUTICAL PLANT

DESIGN ACCORDING TO CGMP

GUIDELINES
MD. Rezwan Ahmed Mahedi
ID No: 11715016

Course Name: Pharmaceutical Product Development

Course Code: PHARM 3105

Submitted to: Rafeja Khatun, Assistant Professor

Comilla
University
Contents
PHARMACEUTICAL PLANT DESIGN
ACCORDING TO cGMP GUIDELINES

Good Manufacturing Practice (GMP)

Pharmaceutical cGMP
DIFFERENCE BETWEEN GMP & cGMP
Importance of cGMP
Pharmaceutical Plant Design
Principles of Plant Design
Factor influencing plant design
Features of a good pharmaceutical plant design
REGULATORY RELATED TO VARIOUS DEPARTMENTAL
AREA
What is GMP?
Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a system for ensuring that products are
consistently produced and controlled according to quality standards. It is designed to
minimize the risks involved in any pharmaceutical production that cannot be
eliminated through testing the final product.

GMP covers all aspects of production.

Helps to ensure the consistent quality and safety of products.
Design and construct the facilities and equipment properly.
Protect against contamination
Pharmaceutical cGMP
cGMP means Current good manufacturing practices are defined by the FDA as
systems to assure proper design, monitoring, and control over manufacturing
processes and facilities in pharma and other FDA-regulated industries. These
systems are designed to help organizations assure drug products are the
correct identity, strength, purity, and quality.

Ensuring pharmaceutical quality .

Includes over–the–counter and prescription small molecule drugs and
biopharmaceuticals( vaccines, antibodies cell therapies etc.)
Applicable in selected scenarios directly related to the manufacturing
processes only.
More reliable in quality assurance
DIFFERENCE BETWEEN GMP & cGMP
GMP cGMP

1. GMP refers to Goods Manufacturing 1. cGMP is current goods

Practices that are guidelines manufacturing practices that need to
followed by over 100 countries. be followed by participating
2. Good Manufacturing Practice countries.
without validation terminology is a 2. Good Manufacturing Practice With
GMP. validation terminology it's a cGMP.
3. GMP applies to pharmaceutical and 3. cGMP is to remind accepting
healthcare products and helps to countries that all guidelines must be
maintain high standards in these followed with the latest and current
products. production processes.
 Importance of cGMP
Safe Consumption
Current good manufacturing practices provide guidance to pharmaceutical companies to
help ensure that their finished products are safe for human consumption.

Therapeutic Effect
A medicine that contains little or none of the claimed ingredients will not have the
intended therapeutic effect.

Qualities
Testing is a part of cGMP, to maintain the product's standard.

Public Health Concern

GMP also controls the quality of food, diagnostics, ingredients in drugs and food, pharmaceutical
products, and devices used in medicine. Thus, GMP makes sure that a company follows a set of rules
and regulations, producing something that meets all the necessary quality requirements.
Pharmaceutical
Plant Design
Pharmaceutical plant design refers to
the allocation of space and
arrangement of machines, furniture,
and other important administration
and necessary service.

It is needed in a production process within a factory

building in order to perform the various unit
operation involved in the manufacturing process of
dosage forms in a cost-effective manner.
Layout Principles of
Design and construct the privileges and
equipments properly Plant Design
Pharmaceutical plants must be
located, designed, constructed,
Tactics
adapted, and maintained to suit
Follow the written procedures and conduct
the proper planning the operations to be carried out.

Instructions
After reviewing the leading international cGMP
Write step-by-step instructions and work
according to the instructions.
guidelines, we can summarize the same in the following
points
Factor Type of
machinery
influencing plant Plant environment
design
Repairs & maintenance

Quality Management
System
Type of machinery
QA
Nature of production
GMP

Factory building
Features of a good pharmaceutical plant
design

The machines should be properly arranged to facilitate minimum material handling and also, The machines
should be properly arranged to facilitate minimum material handling.

Facilitate smooth and continuous flow of production process from one point to another without any form of
delay.

Adequate health, safety and security features such as first aid box, fire extinguisher, emergency exit
and access point.

Effective supervision, coordination and control of the production processes and also, Room for
adjustment and modifications whenever the need arises.
 REGULATORY RELATED TO VARIOUS
DEPARTMENTAL AREA

The regulatory guidelines cover requirements related to the following departments

Storage &
Production Areas Ancillary Areas Sterile Areas Q.C Areas
Weighing Areas

Rest, refressment room Maintenance workshop Animal house Change room, toilets and
washrooms.
Thank You For Watching