M.M.

COLLEGE OF PHARMACY
MAHARISHI MARKANDESHWAR (DEEMED TO BE UNIVERSITY)
MULLANA - AMBALA, HARYANA (INDIA) - 133 207
(Established Under Section 3 of UGC, Act., 1956)
(Accredited by NAAC with Grade ‘A++’)

cGMP & Industrial Management

PRESENTED BY :-
Aditi Kumari (1423716) SUPERVISED BY :-
Ayushi (1423704) Dr. Sukhbir Singh
Tarun (1423715) Professor
M. PHARM (Pharmaceutics) M.M. College of Pharmacy
1st YEAR
Department of Pharmaceutics
 Contents

1. Introduction

2. Objective and policies of current good manufacturing practices

3. Layout of buildings, services, equipments and their maintenance

4. Production management

5. Inventory management and control

6. Sales forecasting, budget and cost control

7. Concept of Total Quality Management

 Introduction
• cGMP refers to the Current Good Manufacturing Practice regulations enforced by the
US Food and Drug Administration (FDA).
• cGMP provide systems that assure proper design, monitoring, and control of
manufacturing processes and facilities.
• Adherence to the cGMP regulations assures the identity, strength, quality, and purity
of drug products by requiring that manufacturers of medications adequately control
manufacturing operations.
• This includes establishing strong quality management systems, obtaining appropriate
quality raw materials, establishing robust operating procedures, detecting and
investigating product quality deviations, and maintaining reliable testing laboratories.
• This formal system of controls at a pharmaceutical company, if adequately put into
practice, helps to prevent instances of contamination, mix-ups, deviations, failures,
and errors.
• This assures that drug products meet their quality standards.
 Benefits of cGMP

They outline Prevent

Ensures Minimizes
a Quality
products are variations in mislabeling Prevent side
system that
safe for use potency of and effects.
reduces
in humans. drug. adultration.
errors.
 Objectives and policies

Objectives of the cGMP

• Ensure that products are consistently manufactured and controlled to the specified
quality.
• Concerned with all aspects of production and quality control .
• In the manufacture of cosmetic products of specified quality.
• Ensure that the consumer receives products of specified quality.
• CGMP regulations assures the identity, strength, quality, and purity of drug products
 Objectives and policies

Policies of the cGMP

Section 1 : Personnel
•There shall be an adequate number of personnel at all levels having
knowledge, skills and capabilities relevant to their assigned
functions, in good mental and physical health to be able to execute
their duties.

•The organizational structure of the company shall be such that the

production and the quality assurance are headed by different
managers like quality control manager, production control manager
etc.

•All employees who are engaged in the manufacturing activities shall

be trained properly that the employees perform in accordance with
the principles of Current Good Manufacturing.
 Objectives and policies

Policies of the cGMP

Section 2 : Premises
•The premises for manufacturing shall be of suitable size, design,
construction and location to facilitate proper operation, cleaning and
maintenance.

•The individual working areas shall be adequate so that any risk of

confusion, cross-contamination will adversely affect the quality of
drugs and devices will be avoided.

•Production areas shall be ventilated with air control facilities.

•Avoid exposed overhead roof joints, pipes and ducts.
•The condition of buildings shall be reviewed regularly, and repaired
where necessary
 Objectives and policies

Policies of the cGMP

Section 3 : Equipment
•Equipment used in the manufacturing of drug products shall be of
appropriate design and construction, adequate size.

•It should be properly installed in order to assure product quality and

process reproducibility and to facilitate its cleaning and
maintenance.

•Equipment shall be subjected to regular maintenance checks at

appropriate intervals to prevent malfunctions or contamination.

•Written procedures shall be established and followed for

maintenance of equipment.

•Validation shall be conducted following a Validation Protocol

 Objectives and policies

Policies of the cGMP

Section 4 : Sanitation and Hygiene

•The sanitation and hygiene program cover personnel, premises,
equipment and apparatus, production materials and containers and
anything that could become a source of contamination to the product.

•It should be validated and periodically assessed to ensure that the

effectiveness of the operation.

•Direct contact shall be avoided between the operator and raw

materials, intermediate or bulk products.

•Records of cleaning, sanitizing, sterilization and inspection shall be

maintained.
 Objectives and policies

Policies of the cGMP

Section 5 : Storage of Starting and packaging materials and finished products

•Materials shall be stored in an order to prevent any risk of mix-up or
contamination and to facilitate inspection and maintenance.

•The materials shall be stored under suitable environmental condition.

•All raw materials, packaging materials, intermediate and bulk
products returned to storage areas shall be properly documented and
reconciled.

•Rejected raw materials and packaging materials shall not be stored

together with approved materials.

•The First Expiry First Out system (FEFO) on approved raw materials
shall be used.
 Objectives and policies

Policies of the cGMP

Section 6 : Production
•Production shall follow defined procedures capable to provide
assurance that drug products to conform their specification.

•Manufacturing facilities and methods shall be designed to prevent

cross-contamination.

•Process Validation
•The presence in a drug product of any contaminant is unacceptable
•A batch and/or lot numbering system applied to a processing state
and finished product
 Objectives and policies

Policies of the cGMP

Section 7 : Packaging
•Packaging operations shall be performed under strict control to
protect the identity, integrity and quality of the final package.

•All packaging operations shall proceed in accordance with a SOP.

•Coding of components shall take place in an area isolated from other
packaging operations.

•Written in-process control procedures shall be followed.

 Objectives and policies

Policies of the cGMP

Section 8 : Finished products quarantine and delivery to warehouse

•Finished product quarantine is the last point of control before the
product enters the warehouse and available for distribution to the
market.

•Strict controls shall be maintained to ensure that the product and its
packaging records meet all specified requirements before release to
the warehouse.

•Written procedures should be maintained for the transfer of finished

product into the quarantined area, and subsequent transfer to the
finished goods warehouse.
 Objectives and policies

Policies of the cGMP

Section 9 : Quality Control

•Quality Control is an essential part of Good Manufacturing Practices to
provide assurance that the products will be consistently of a quality
appropriate to their intended use.

•An independent quality control unit shall be established.

•A quality control system shall be developed to ensure that finished
products contain the correct materials of specified quality and quantity
and are manufactured under proper conditions following standard
procedures.

•Quality control involves all analytical functions conducted in the

laboratory, including sampling, inspecting and testing of starting
materials, intermediate, bulk and finished products
 Objectives and policies

Policies of the cGMP

Section 10 : Documentation
•Documents shall be prepared and designed carefully for easy, correct and
effective use.

•Documents shall contain records of activities within production, quality

control, equipment maintenance, warehouse, distribution and other specific
activities related to Good Manufacturing Practice.

•A master production document should include the product name, dosage

form, strength and description, the writer’s name and department, name of
verifier and list of document distribution.

•Batch Processing Record

•Master packaging procedure
 Objectives and policies

Policies of the cGMP

Section 11 : Self Inspection

•The purpose of self-inspection is to evaluate the manufacturer’s
compliance with Good Manufacturing Practices on all aspects of
production and quality control.

•Self-inspection shall be performed routinely and corrective actions

shall be implemented.

•A team consisting of personnel who can evaluate the implementation

of Good Manufacturing Practices objectively shall be appointed.

•The procedure and record for self-inspection shall be documented

 Objectives and policies

Policies of the cGMP

Section 12 : Guidelines for Handling of Product Complaint, Product recall or

Returned Products
•A product complaint and report may relate to the quality, adverse
reaction or other therapeutic effect of the product.

•A follow-up action shall be taken after investigation and evaluation of

the product complaint and report.

•A product recall is a process of withdrawing one or more batches or

all of a certain product from market distribution.

•A returned product is a finished product which is already in

distribution and returned to the manufacturer due to complaint,
damage, expiration, validity or other reasons.
Layout of buidings, services, equipments and their maintenance

Principle

The layout and design should aim to :

Minimize risks of error
Permit effective maintenance
Avoid cross-contamination, build-up of dirt and dust
Avoid any adverse effect on the quality of problems

Design………..
• Process flow
• Material flow
• People flow
Layout of buidings, services, equipments and their maintenance

Layout of building and services

• Means all buildings where manufacture of the products wil take place.
• Conditions that's exist within them and the area of location.
• Important aspect ot be kept along ot ensure suitability of the operation
Location
Design
Construction
Adaptation (new processes + future extensions)
Maintenance
• Important to understand the manufacturing processes and conduct the facility programming.
• Facility layout must be an integrated design that satisfies the following:
Process requirements
Personnel flows
Material flows (product, component and raw material movements)
Equipment layout requirements
Operational access requirements
Maintenance access requirements
Layout of buidings, services, equipments and their maintenance

• Prevention of cross contamination

• Proper air handling system
• Proper cleaning & sanitary conditions
• Proper lighting
• Proper plumbing
• Proper washing
Layout of buidings, services, equipments and their maintenance

Layout of equipments
• Should be selected based on the intended use and cleanability.
• Must be placed in an appropriate location.
• Must be properly qualified (design, installation, operation, performance).
• Constructed so that, surfaces are non reactive.
• Automatic, mechanical & electronic equipments should be calibrated, inspected or checked as
per written program to assure proper performance.

• Computer input/output checked for accuracy.

Layout of buidings, services, equipments and their maintenance

Equipments maintenance
• Weighing, measuring, testing & recording equipment should be serviced & calibrated
regularly.

• All records should be maintained.

• Written procedures should include :-

1. Responsibility for equipment cleaning & maintenance.
2. Cleaning & sanitizing schedules.
3. Detailed description of cleaning.
4. Removal of previous batch identification.
5. Protection of clean equipment.
6. Inspection of equipment prior to use.
 Production Management

Concept of Production
• Production is defined as “the step-by-step conversion of one form of material into another
form through chemical or mechanical process to create or enhance the utility of the
product to the user”.

• Thus production is a value addition process. At each stage of processing, there will be value
addition.

• Edwood Buffa defines production as ‘a process by which goods and services are created’.

Example for Production

• Manufacturing custom-made products :
Like - 1.Boilers with a specific capacity
2.Constructing flats
3.Structural fabrication works for selected customers, etc.
 Production Management

Production System
• The production system of an organization is that part, which produces
products of an organization.
• It is that activity whereby Resources, flowing within a defined system,
are combined & transformed in a controlled manner to add value in
accordance with the policies communicated by management.
 Objective of Production Management

• The objective of the production management is ‘to produce goods services of right
quality and quantity at the right time and right manufacturing cost’.

1. RIGHT QUALITY : The quality of product is established based upon the

customers needs. The right quality is not necessarily best quality. It is
determined by the cost of the product and the technical characteristics as suited
to the specific requirements.
2. RIGHT QUANTITY : The manufacturing organization should produce the
products in right number. If they are produced in excess of demand the capital
will block up in the form of inventory and if the quantity is produced in short of
demand, leads to shortage of products.
3. RIGHT TIME : Timeliness of delivery is one of the important parameter to judge
the effectiveness of production department. So, the production department has
to make the optimal utilization of input resources to achieve its objective
 Objective of Production Management

4. RIGHT MANUFACTURING COST :

• Manufacturing costs are established before the product is actually
manufactured.

• All attempts should be made to produce the products at pre-established

cost, so as to reduce the variation between actual and the standard (pre-
established) cost.
 Production Management

CLASSIFICATION
Production System can be Classified as :

1.Job Shop Production

2.Batch Production

3.Mass Production

4. Continous Production
 Production Management

1. JOB SHOP PRODUCTION

• Job shop production are characterised by manufacturing of one or few quantity
of products designed and produced as per the specification of customers within
prefixed time and cost.

• The distinguishing feature of this is low volume & high variety of products.

• A job shop comprises of general purpose machines arranged into different

departments.

• Each job demands unique technological requirements, demands processing on

machines in a certain sequence.
Production Management

ADVANTAGES

Operators will
Because of general become more
purpose machines skilled &
and facilities variety competent, as each
of products can be job gives them
produced. learning
opportunities.

Full potential of Opportunity exists

operators can be for creative methods
utilized. & Innovative ideas.
 Production Management

2. BATCH PRODUCTION

• Batch production is defined “as a form of manufacturing in which the job passes
through the functional departments in lots or batches and each lot
may have a different routing.”

• It is characterised by the manufacture of limited number of products produced at

regular intervals and stocked awaiting sales.
 Production Management

ADVANTAGES

Flexibility to
Lower investment in
Job satisfaction accommodate and
plant and
exists for operators. process number of
machinery.
products.

Cost per unit is

lower as compared Promotes functional Better utilisation of
to job shop specialisation. plant and machinery
production.
 Production Management

3. MASS PRODUCTION
• “Manufacture of discrete parts or assemblies using a continuous process are called
mass production”.

• This production system is justified by very large volume of production.

• The machines are arranged in a line or product layout. Product and process
standardisation exists and all outputs follow the same path.

• Material handling can be completely automatic.

 Production Management

ADVANTAGES

Higher rate of Higher capacity

production with utilisation due to
reduced cycle time. line balancing.

Less skilled Manufacturing

operators are cost per unit is
required. low.
 Production Management
4.CONTINUOUS PRODUCTION
• Production facilities are arranged as per the sequence of
production operations from the first operations to the finished
product.

• The items are made to flow through the sequence of operations

through material handling devices such as conveyors, transfer
devices, etc.
 Production Management
Standardisatio
n of product
and process
and process Higher rate
Higher sequence.
of
capacity of
production
utilisation
with
due to line
reduced
balancing.
cycle time.
ADVANTAGE

Man power Unit cost is

is not lower due to
required for the high
material volume of
handling. Person with production.
limited skills
can be used
on the
production
line.