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M.PHARM I SEM DEPT. OF PHARMACEUTICS

JAMIA HAMDARD UNIVERSITY

 

Contents

• GMP
• cGMP
• Objectives and policies of cGMP
• Layout of buildings
• Services
• Equipments and their maintenance

 

Good Manufacturing
Practice (GMP)

• WHO defines Good
Manufacturing Practices (GMP)
as “that part of quality assurance
which ensures that products are
consistently produced and
controlled to the quality
standards appropriate to their
intended use and as required by
the marketing authorization.”

 

• GMP rules are directed primarily to diminishing
the risks, inherent in any pharmaceutical
production, that cannot be prevented completely
through the testing of final products.

• Such risks are essentially of two types:

cross-contamination (in particular by unexpected
contaminants)

mix-ups (confusion) caused by false labels being
put on containers.

 

Basic Principles of GMP
• Quality, safety and efficacy must be

designed & built in the product.
• Testing alone cannot be relied on to ensure

quality.
• Each step in the manufacturing process

must be controlled to ensure that the final
product lies within limits and specifications.

 

Building Blocks Of GMP

 

GMP MANUFAUTURING ENVIRONMENT

GMP MANUFACTURING ENVIRONMENT

PERSONNEL PRODUCT ENVIRONMENT
PROTECTION PROTECTION PROTECTION

Prevent
Protect from Avoid

contact
dust

with dust product
cross-contamination discharge

Prevent
Protect from Avoid

contact
ambient fume

with fumes
contamination discharge

Acceptable Prevent Avoid
comfort contamination effluent

conditions of staff discharge

Correct
temperature
and humidity

 

Aspects of GMP
GMP covers all aspects of :-
• defined manufacturing process

• validated critical manufacturing steps

• suitable premises, storage, transport

• qualified and trained production

• quality control personnel

• adequate laboratory facilities

 

Contd..

• approved written procedures and instructions

• records to show all steps of defined procedures

• full traceability of a product through batch &
distribution records

• systems for recall and investigation of complaints

 

Current Good Manufacturing
Practices (cGMP)
• cGMP stands for “current,” requiring companies to

use technologies and systems that are up-to-date in
order to comply with the regulations.

• Systems and equipment that may have been “top-
of-the-line” to prevent contamination, mix-ups, and
errors 10 or 20 years ago may be less than adequate
by today’s standards.

• cGMP assure the safety and efficacy of the
finished products.

 

Objectives and Policies of
cGMP
• To provide assurance of a drug product’s identity,

strength, quality and purity.

• To assure proper design, monitoring, and control of
manufacturing processes and facilities.

• To establish strong quality management systems,
obtaining appropriate quality raw materials,
establish robust operating procedures, detecting
and investigating product quality deviations, and
maintaining reliable testing laboratories.

 

Contd.….

• To prevent instances of contamination, mix-ups,
deviations, failures, and errors which assures drug
products meet their quality standards.

• To allows companies to use modern technologies and
innovative approaches to achieve higher quality
through continual improvement.

• To assure that quality is built into the design and
manufacturing process at every step.

 

Pharmaceutical cGMPs for the 21st
Century: A Risk-Based Approach

• To encourage the early adoption of new
technological advances by the pharmaceutical
industry

• To facilitate industry application of modern quality
management techniques, including implementation
of quality systems approaches, to all aspects of
pharmaceutical production and quality assurance

• To encourage implementation of risk-based
approaches that focus both industry and Agency
attention on critical areas

 

Contd….

• To ensure that regulatory review and inspection
policies are based on state-of-the-art
pharmaceutical science

• To enhance the consistency and coordination of
FDA’s drug quality regulatory programs, in part, by
integrating enhanced quality systems approaches
into the Agency’s business processes and regulatory
policies concerning review and inspection activities

 

US FDA cGMP Regulation

• 21 Code of Federal Regulations Part 210:- Current
Good Manufacturing Practice in Manufacturing
Processing, packing, or Holding of Drugs.

• 21 Code of Federal Regulations Part 211:- Current
Good Manufacturing Practice for Finished
Pharmaceuticals.

 

cGMP for Finished
Pharmaceuticals
• Subpart A–General Provisions

§ 211.1 – Scope.
§ 211.3 – Definitions.

• Subpart B–Organization and Personnel
§ 211.22 – Responsibilities of quality control unit.
§ 211.25 – Personnel qualifications.
§ 211.28 – Personnel responsibilities.
§ 211.34 – Consultants.

• Subpart C–Buildings and Facilities
§ 211.42 – Design and construction features.
§ 211.44 – Lighting.
§ 211.46 – Ventilation, air filtration, air heating and cooling.
§ 211.48 – Plumbing.
§ 211.50 – Sewage and refuse.
§ 211.52 – Washing and toilet facilities.
§ 211.56 – Sanitation.
§ 211.58 – Maintenance.

 

• Subpart D–Equipment
§ 211.63 – Equipment design, size, and location.
§ 211.65 – Equipment construction.
§ 211.67 – Equipment cleaning and maintenance.
§ 211.68 – Automatic, mechanical, and electronic equipment.
§ 211.72 – Filters.

• Subpart E–Control of Components and Drug Product Containers and Closures
§ 211.80 – General requirements.
§ 211.82 – Receipt and storage of untested components, drug product containers, and

closures.
§ 211.84 – Testing and approval or rejection of components, drug product containers,

and closures.
§ 211.86 – Use of approved components, drug product containers, and closures.
§ 211.87 – Retesting of approved components, drug product containers, and closures.
§ 211.89 – Rejected components, drug product containers, and closures.
§ 211.94 – Drug product containers and closures.

• Subpart F–Production and Process Controls
§ 211.100 – Written procedures; deviations.
§ 211.101 – Charge-in of components.

 

• § 211.103 – Calculation of yield.

§ 211.105 – Equipment identification.
§ 211.110 – Sampling and testing of in-process materials and drug products.
§ 211.111 – Time limitations on production.
§ 211.113 – Control of microbiological contamination.
§ 211.115 – Reprocessing.

• Subpart G–Packaging and Labeling Control
§ 211.122 – Materials examination and usage criteria.
§ 211.125 – Labelling issuance.
§ 211.130 – Packaging and labelling operations.
§ 211.132 – Tamper-evident packaging requirements for over-the-counter (OTC) human

drug products.
§ 211.134 – Drug product inspection.
§ 211.137 – Expiration dating.

• Subpart H–Holding and Distribution
§ 211.142 – Warehousing procedures.
§ 211.150 – Distribution procedures.

 

• Subpart I–Laboratory Controls
§ 211.160 – General requirements.
§ 211.165 – Testing and release for distribution.
§ 211.166 – Stability testing.
§ 211.167 – Special testing requirements.
§ 211.170 – Reserve samples.
§ 211.173 – Laboratory animals.
§ 211.176 – Penicillin contamination.

• Subpart J–Records and Reports
§ 211.180 – General requirements.
§ 211.182 – Equipment cleaning and use log.
§ 211.184 – Component, drug product container, closure, and labelling records.
§ 211.186 – Master production and control records.
§ 211.188 – Batch production and control records.
§ 211.192 – Production record review.
§ 211.194 – Laboratory records.
§ 211.196 – Distribution records.
§ 211.198 – Complaint files.

• Subpart K–Returned and Salvaged Drug Products
§ 211.204 – Returned drug products.
§ 211.208 – Drug product salvaging.

 

Sub part c : Buildings and Facilities

• Layout is the organized plan of inter department
and intra department arrangement

• Proper layout increase productivity & helps in
proper utilization of man ,material, money and
machine

 

Layout of Buildings

Designed a/c to cGMP which ensures

• Prevention of cross contamination

• Proper air handling system

• Proper cleaning and sanitary facilities

• Proper lightening

• Proper plumbing and washing

 

 

• LIGHTENING

• Adequate lighting should be provided in all areas to
facilitate cleaning, maintenance, and proper
operations.

• A range of 30–50 foot-candles ensures worker comfort
and ability to perform efficiently and effectively;
however, 100 foot-candles may be needed in some
areas, as well as special lighting for some operations,
such as inspection of filled vials.

 

• AIR HANDLING SYSTEMS
HVAC – Heating

Ventilation

Air Conditioning

The environment comprises aspects such as:

1. Temperature

2. Humidity

3. Air movement

4. Microbial contamination

5. Particulate contamination

• Air-handling systems for the manufacture, processing and packing of penicillin
shall be completely separate from other products.

 

PLUMBING
• Potable water shall be supplied under continuous

positive pressure in a plumbing system free of
defects that could contribute contamination to any
drug product.

• Potable water shall meet the standards prescribed
in the Environmental Protection Agency’s (EPA)
Primary Drinking Water Regulations set forth in 40
CFR Part 141

 

• SEWAGE AND REFUSE

• Sewage, trash, and other refuse in and from the
building and immediate premises shall be disposed of
in a safe and sanitary manner.

• Product disposal- disposed of in an approved landfill
site

• Printed packaging disposal-such materials should
preferably be incinerated

 

• WASHING AND TOILET FACILITIES

• Adequate washing facilities should be provided,
including hot and cold water, soap or detergent, air
driers or single-service towels, and clean toilet
facilities easily accessible to working areas.

 

• SANITATION
• Building shall be free of infestation by rodents, birds,

insects and other vermin (other than laboratory animals).
Trash and organic waste matter shall be held and disposed
of in a timely and sanitary manner.

• Written procedures should describe the cleaning schedules,
methods, equipment, and materials to be used in cleaning
the buildings and facilities.

• Cleaning of floors, walls, and ceilings, there should be
attention to dust extraction and air input systems

 

Equipments and their
Maintenance
• EQUIPMENT DESIGN, SIZE AND LOCATION
• Equipment used should be of appropriate design, adequate size,

and suitably located to facilitate operations for its intended use
and for its cleaning and maintenance.

• Operating criteria are adequate for the process.

• Availability of spares and servicing

• Maintenance.

• Environmental issues-dust generation

• Availability of design and maintenance manuals from the
supplier.

 

• EQUIPMENT CONSTRUCTION

• Equipment should be constructed so that surfaces
that contact in-process material should not react,
add, or absorb so as to alter the safety, identity,
strength, quality, or purity of the drug product
beyond the official or other established
requirements.

 

• EQUIPMENT CLEANING AND MAINTENANCE

• Equipment and utensils should be cleaned, maintained,
and sanitized at appropriate intervals to prevent
malfunctions or contamination.

• Written procedures shall be established and followed
for cleaning and maintenance of equipment, including
utensils, used in the manufacture, processing, packing,
or holding of a drug product.

 

• AUTOMATIC, MECHANICAL & ELECTRONIC
EQUIPMENT

• Automatic equipment’s should be routinely calibrated,
inspected or checked according to a written program
designed to assure proper performance.

• Written records of those calibration checks and
inspections shall be maintained.

• A backup file of data entered into the computer or
related system should be maintained.

 

Services
• In the building design, provisions must be made for drains,

steam, electricity, water and other services to allow for
ease of maintenance.

• Access should, ideally, be possible without disruption of
activity within the actual rooms provided with the services.

• Doors and window frames should all have a hard, smooth,
impervious finish, and should close tightly. Window and
door frames should be fitted flush, at least on sides facing
inward to processing areas. Doors, except emergency exits,
should not open directly from production areas to the
outside world.

 

References
 Good manufacturing practices for pharmaceutics. A Plan for

total quality control 4th edition, Revised & Expanded Vol. 78,
Sidney H. willing James R Stoker, page 33-51

 Quality assurance of pharmaceuticals A compendium of
guidelines and related materials Volume 2, 2nd updated edition
Good manufacturing practices and inspection-WORLD HEALTH
ORGANISATION

 

Thank you