GMP - EQUIPMENT
M. Pharm Sem-1
Q.A . Department
Mr. Jignesh S. Shah
S. J. Thakkar Pharmacy College - Rajkot.
OVER VIEW FOR EQUIPMENT
Equipment design, size and location
Cleaning and maintenance
Automated, mechanical and electronic equipment
Equipment may be defined as a physical entity which is used to
carry out a general or specific activity in the plant.
Equipment is the major inputs in the manufacture of the
pharmaceutical products, in the regulatory literature on GMP in
various countries gives the importance & hence provide
guidelines on the management of equipment in pharmaceutical
Equipment may be :
Single system or piece,
Selection of equipment has both strategic and financial impact on the
It is an essential for any company because it has direct influence on the
success of the product facilities by optimum cost ,improving quality , safety
and reducing environmental hazards.
Factor that affect selection of equipment
a) Operating criteria,
b) Availability of spares and servicing
d) Environmental issues,
e) Availability of design & maintenance manuals,
design, size and location
Equipment used in the manufacture, processing, packing or holding
of a drug product shall be of appropriate design, adequate size, and
suitably located to facilitate operations for its intended use.
Availability of design and maintenance manuals from the supplier
that are important for validation/qualification and maintenance
Equipment suitably located & designed for easy cleaning and
Equipment shall be constructed so that surfaces that contact
components & drug products shall not be reactive or absorptive as it
alter the safety, identity, strength, quality or purity of the drug
The construction material used for parts which are direct contact
with products & manufacturing vessels may be stainless steel 316 or
Borosilicate glass & tubing should be capable of being washed and
Any substances required for operation such as lubricants or coolants
shall not come into contact with components, drug product
containers closures or drug products.
All compounding and storage containers, processing lines and
major equipment used during production of a batch of drug product
shall be properly identified at all times to indicate their content.
Major equipment shall be identified by a distinctive identification
no. or code that shall be recorded in the batch production record to
show the specific equipment used in the manufacture of each batch
of drug product.
Cleaning And Maintenance
Equipment and utensils shall be cleaned, maintained, and sanitized
at appropriate intervals to prevent 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.
A cleaning procedure desired at end of working shift only for
equipment in which a wet processing stage has been carried out.
Cleaning and washing may be :
-CIP , -SIP
why it is important?
Essential to establish adequate cleaning procedures.
Cleaning validation should be performed in order to confirm
the effectiveness of a cleaning procedure.
The data should support a conclusion that residues have
been reduced to an ‘acceptable’ level.
HPLC, GC, HPTLC, pH , Conductivity, UV, ELISA.
Every equipment must have SOP’s for operation, cleaning and
maintenance. There may be system to distinguish equipment in
Operational equipment ( with green card ),
Equipment under maintenance ( yellow card ),
Defective equipment (red card ).
The operator doing cleaning and maintenance must be so
trained that their activities of cleaning and maintenance will
not affect or contaminate product.
Records of all activities on equipment must be
chronologically recorded in the equipment log book.
Types of Maintenance
Equipment Maintenance: defined as facilities maintain to some desired
level of efficiency to keep assets in a satisfactory condition.
It means that people waits until equipment fails and repair it. Such a thing could
be used when the equipment failure does not significantly affect the operation
or production or generate any significant loss other than repair cost.
Corrective maintenance ( 1957 ):-
It improves equipment and its components so that preventive maintenance can
be carried out reliably. Equipment with design weakness must be redesigned to
improve reliability or improving maintainability .
Maintenance prevention ( 1960 ):-
It indicates the design of a new equipment. Weakness of current machines are
sufficiently studied and are incorporated before commissioning a new
Preventive maintenance ( 1951 ) :-
It is a daily maintenance ( cleaning, inspection, oiling and re-tightening ),
design to retain the healthy condition of equipment and prevent failure through
the prevention of deterioration, periodic inspection or equipment condition
diagnosis, to measure deterioration. It is further divided into periodic
maintenance and predictive maintenance.
• Periodic maintenance ( Time based maintenance - TBM) :
Time based maintenance consists of periodically inspecting, servicing and
cleaning equipment and replacing parts to prevent sudden failure and process
• Predictive maintenance :-
This is a method in which the service life of important part is predicted based
on inspection or diagnosis, in order to use the parts to the limit of their service
life. Compared to periodic maintenance, predictive maintenance is condition
SOP on cleaning, operation and maintenance
Name of equipment and its unique identification no.
Responsible person to carry out and supervise operation
schedule maintenance and cleaning.
Material use for cleaning and its complete removal after cleaning.
Removal of previous batch identification.
Protection of cleaned equipment.
Inspection of cleaned equipment.
Detailed step by step operation of equipment.
Detailed step by step prcedure to carry out prevententive maintenance.
Record of cleanig, maintenance and operation.
Department : Month:
Equipment identification No.: Working Capacity:
Cleaning sop no.: Maintenance sop no.:
Date Sign Remark Date Sign Remark
Equipment cleaning & maintenance record
INDIAN PHARMACEUTICAL LTD.
Daily maintenance record sheet
Sr. no. Department Work
Work left for next day:______________________________________
Work performed by Inspected by Deptt. Head
INDIAN PHARMACEUTICAL LTD.
Machine breakdown card
Name Of Machine: Room No.:
Date Time Type of
Replace From To
USP divides the equipment into three groups based
on respective complexity
Group A Group B Group C
•E.g. stirrer •E.g. pH meter,
confirm that it is
must be followed.
•Though testing of
their qualification is
•Deep n complete
literature must be
There are four qualification phases are also described by
the WHO's Good Manufacturing Practices Guide for
Quality Assurance of Pharmaceuticals.
These types of equipment includes computers or related
systems that will perform a function satisfactorily, may
be used in the manufacture, processing, packing, and
holding of a drug product. It 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.
AUTOMATIC, MECHANICALAND ELECTRONIC
Appropriate controls shall be exercised over computer or related system
to assure that changes in master production and control records or other
records are instituted only by authorized personnel.
Input and output from the computer or related system of formulas or
other records or data shall be checked for accuracy.
The degree and frequency of input/output verification shall be based on
the complexity and reliability of the computer or related system
A backup file of data entered into the computer or related system shall
be maintained except where certain data, such as calculations performed
in connection with laboratory analysis, are eliminated by computerization
or other automated processes. In such instances a written record of the
program shall be maintained along with appropriate validation data.
Filter used as a part of equipment & Filtration is one of the processes use in
pharmaceutical operation and air systems.
Filter for liquid filtration used in the manufacture, processing or packing of
injectable drug products intended for human use shall not release fiber into
As a part of GMP, filters should be considered from following:
Type of filter and filration process,
Compatibility of filter media with processing material,
Cleaning of reusable filter and their sanitization,
validation of filter,
Disposal of filter.
INDIAN PHARMACEUTICAL LTD.
Pre-air filter record
Clean by Manometer
Name of filter:
Balance and other measuring equipment of appropriate range and precision
should be available for production and control operation.
Measuring, weighing, recording and control equipment should be calibrated
& checked at defined interval by appropriate method. Adequate record of such
tests should be maintained.
All weighing balance should be in a state of calibration. The name, signature
and date of person weighing and supervising weighing operations must be
A list of various weighing balance should be made with following:
Description of balance ,
Frequency of calibration.
Purchase specification of equipment
Definition:- Detailed description of the measurable characteristics
desired in an equipment to be purchased such as quality, size,
weight , performance parameters, safety requirements etc.
The documents used for the procurement of equipment should
User Requirement Specification
Relevant Standard Demand Specifications, and
Purchase specification of UV-VIS Spectrophotometer, double beam
Wavelength : 190-900 nm or more
Optical System : Double beam with double monochromator
Light Source : D2 and Tungsten
Wavelength accuracy : +/- 0.1 nm
Spectral Bandwidth : at least, 0.5, 1, 2, 5 (variable)
Photometric Range : at least -0.3~3 Abs
Photometric Modes : Abs,%T
Stray Light minimum
Wavelength Scan Speed : 800-10 nm/min
Baseline Stability : +/-0.0008Abs/Hour or less
Detector : Photomultiplier R928
Control : By Computer
Branded Computer monitor with latest specification
D2 Lamp, tungsten Lamp
5 years maintenance of the system
Purchase specification of water bath
10 L to 15 L water tank volume
Water circulation to maintain uniform temperature
Working temperature : ambient +5˚C to 100˚C or more
Stability : ±0.1˚C or less
Increment : ±1˚C or less
Microprocessor control for precise temperature
Audible and visible alarms
LED display with 0.1˚C resolution for temperature
Operable at 220 volts
5 year equipment maintenance
SOP for Equipment
Definition: A written authorized procedure which gives instructions for
performing operations necessarily specific to a given equipment.
What are SOPs ?
They are the tools to ensure that GMP is being followed wherever
It contains relevant information about any activity or process carried
out (like calibration validation , maintenances , cleaning , production ,
packing or even for receipt or movement of raw material ).
Why SOPs are needed?
Due to demand of safe and efficacious drug product in the market.
In addition to clinical factors storage , handling of raw material and
final product , cross contamination and batch to batch deviation
affects the quality of product.
We don’t want any loss or refusal.
Precautions for preparing SOPs:-
Information & procedures in clear and unambiguous language and
specifications for the facilities should be provided.
By following SOPs the quality product should be expected.
Significant deviations are recorded and investigated.
Documents must not be changed or added or reviewed or amended without any
Easy to retrieve from master SOP and check also critical steps should be
Must not allow any error.
Regularly updated and previous suspended SOPs are preserved for at least 1
year after the last batch made on it has been expired.
Original copy is kept in locker and one copy is displayed in all the concern
areas and retained with each member who has signed in it.
GOOD QUALITY PHARMACEUTICALS PVT. LTD.
STANDARD OPERATING PROCEDURE
Name of equipment:-
Department : Procedure no.: Page no. : _ to_
Effective Date : Superceeds earlier procedure date : Review date :
INDIAN PHARMACEUTICALS LTD.
List of equipment
Sr. No. Name of
Make Date Of
Laboratory Master File of Instruments
C-Gmp for pharmaceutical by Manohar A. Potdar
Quality Manual, by D. H. Shah
Good Manufacturing Practices for Pharmaceuticals, vol. 109 ,
Marcel Dekkar Inc., N. Y.