10 GMP

WRITE PROCEDURE
FOLLOW THE WRITTEN PROCEDURE
3 DOCUMENT OR RECORD THE WORK
4 VALIDATE THE WORK
5 DESIGN BUILD PROPER FACILITIES AND EQUIPMENTS
6 MAINTAIN FACILITIES AND EQUIPMENT
7 BE COMPETENT ( EDUCATED , TRAINED ,EXPERIENCE )
8 BE CLEAN
CONTROL FOR QUALITY
AUDIT FOR COMPLIANCE
 Building and Facilities
I. Design and construction features.
II. Adequate and suitable lighting should be provided in all areas.
III. Heating, ventilation, and air conditioning (HVAC).
IV. Plumbing (all Piping system).
V. Sewage, trash, and other refuse in and from the building and
immediate premises must be disposed of in a safe and sanitary
manner.
VI. Adequate washing facilities should be provided. This is to include hot
and cold water, soap or detergent, air driers or single-service towels,
and clean toilet facilities easily accessible to all work areas.
VII. Sanitation.
VIII.All buildings used for GMP-related purposes must be maintained in a
good state of repair.
 Building and Facilities

1) Equipment should be of appropriate design, adequate size, and

suitably located to facilitate operations for its intended use and for
maintenance.
Design for Maintainability.
Ergonomics.
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2) Equipment construction.
a) Equipment should be constructed so that surfaces that contact components, in-
process materials, or drug products should not be reactive, additive, or
absorptive so as to alter the safety, identity, strength, quality, or purity of the
drug product beyond official or other established requirements.
b) Any substance required for operation such as lubricants or coolants shall not
come into contact with drug products, containers, and so on, so as to alter the
safety, identity, strength, quality, or purity of the drug product beyond
established requirements.
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3) Equipment cleaning and maintenance.

a) Equipment and utensils should be cleaned, maintained, and sanitized at
appropriate intervals to prevent malfunctions or contamination that would alter
the drug product beyond the official requirements.
 Building and Facilities
3) Equipment cleaning and maintenance.
b) Written procedures must be established and followed for cleaning and
maintenance of equipment and utensils used in the processing of a drug
product. These procedures must include but are not limited to the following:
i. Assignment of responsibility for cleaning and maintaining equipment.
ii. Maintenance and cleaning schedules, including sanitizing schedules if appropriate.
iii. A sufficiently detailed description of the methods, equipment, and materials used in
cleaning and maintenance operations and the methods of disassembling and reassembling
equipment as a part of cleaning and maintenance.
iv. Records should be kept of maintenance, cleaning, sanitizing, and inspection of all
processing equipment.
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4) Automatic, mechanical, and electronic equipment.

All such equipment, including computers or related systems that will perform a

function to be used in any GMP-related activity, must be routinely calibrated,

inspected, or checked according to a written program designed to assure

proper performance.
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5) Filters for liquid filtration.

used as a part of the manufacture, processing, or packing of
injectable drug products intended for human use must not release
fibers into such products. In this situation, an additional non-fiber-
releasing filter of 0.22 µm maximum must be used after the fiber-
releasing filtration.
 Building and Facilities

What is Maintenance?
• All Activities aiming to keep Process, Equipment or facility at a
healthy state to produce desired output.
• Keep Process, Equipment or facility functioning well as initially
designed.
 Building and Facilities

Engineering Maintenance
• After a good design stage make sure all time that Equipment or
facility is functioning safe for:-
 Human,
 Equipment itself,
 Product and
 Environment.
 Building and Facilities

Engineering Maintenance Major Activities

• Cleaning.
• Lubrication.
• Monitoring.
• Testing.
• Corrective, Preventive and Proactive actions.