This document provides guidelines on Good Manufacturing Practices (GMP) for equipment used in the pharmaceutical industry. It discusses the selection criteria, design and construction, installation, cleaning and maintenance, documentation requirements for equipment. Automatic, mechanical and electronic equipment must be routinely calibrated and inspected according to a written program. Proper documentation and record keeping is essential to ensure equipment is functioning properly and producing quality products.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
Logbook For Industrial Supervision and Training- A Look at Paper and Digital ...Olufemi Jeremiah Olubodun
Logbook has been in use for many years and mostly for keeping records and these records could be personal or official. Anyone keeping record defines the criteria and the format it will take. For training institutions format of a logbook is well laid out for students to just fill in blank spaces. This has a lot of limitations. However, logbook is usually paper based and few digital logbooks available placed a number of restrictions on the user such that they are not very useful for industrial training. This paper looks at logbook in diverse ways and it was a product of a research conducted at the College of Medicine of the University of Lagos, Lagos Nigeria. This will expose the reader to a number of salient details often ignored about logbook
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy
Content :-
Current good manufacturing Practices
Equipment and their maintenance
Production Management
Conclusion
References
cGMP refers to Current Good Manufacturing Practices (CGMP) regulations enforced by US FDA .
CGMP are the methods to be used in ,the facilities or controls to be used for ,the manufacturing ,processing, packaging or holding of a drug to assure that such drug meets
The requirements of the act, and has the identity and strength and meets the quality and purity characteristics that is represented to possess.
ICH guidelines for validation Of Equipments by Nikita Sahu[1].pptxNikitaSahu39
VALIDATION- As per WHO,
Validation means providing documented evidence that any procedure, process, activity or system actually leads to the expected results.
As per FDA , Validation is establishing documented evidence, which provides a high degree of assurance that a specific process will produce a product meeting its pre determined specification & quality attributes.
1. Good Manufacturing
Practices (GMP) Guidelines
FOR EQUIPMENTS
Prepared By: Modi Nirav
M.Pharm (Q.A.), Semester-1
Guided By: Vishnubhai M. Patel
A.P.M.C.COLLEGE OF PHARMACY,
HIMMATNAGAR.
2. GMP
GMP
CONTENT: For
For
Equipment
Equipment
ss
Introduction
Selection criteria
Design and Construction
Installation
Cleaning and maintenance
Documentation
Automatic, mechanical and electronic
equipments.
3.
4. GMP
GMP
Introduction: For
For
Equipment
Equipment
ss
Equipments is important factor which can affect
the quality of drug to great extent.
Equipment used in the manufacture, processing,
packing of a drug product shall be of appropriate
design, adequate size, and suitably located to
facilitate operations for its intended use and for
its cleaning and maintenance.
The effectiveness of equipment, like the quality
of a product, starts at the design stage.
5. GMP
GMP
Selection criteria: For
For
Equipment
Equipment
ss
1. Operating criteria (size, speed, effectiveness)
2. Availability of spares and servicing
3. Maintenance
4. Easy accessibility and cleanability
5. Environmental issues
6. Construction materials and design.
7. Availability of process controls
8. Cost
9. Availability of design and maintenance manuals
from the supplier
6. GMP
GMP
For
For
Equipment
Equipment
ss
• New equipment should not be used for
commercial production until it has been qualified
and the process in which it is to be used has been
validated; this applies equally to laboratory and
other test equipment.
7. GMP
GMP
Design and construction: For
For
Equipment
Equipment
ss
Equipment used in manufacturing process,
handling or storage should be of suitable design and
of adequate capacity to facilitate the operations for
which it is intended.
Not allow to contact any in process material.
do not affect the product adversely in case of leakage.
Those parts of equipment which come into contact
with any material should be made of material which
would not be reactive, additive or absorptive.
8. GMP
GMP
For
For
Equipment
Equipment
ss
Equipment for processing inflammable
materials should be equipped with explosion
proof electrical parts.
Equipment used for critical steps should have,
as far as recording devices. If it is not possible,
other measuring devices like pressure gauge
should be fixed at easily accessible location.
9. Appropiate design :
• Easily clened on a schedule basis.
• FOR THE SAFETY OF PRODUCT
• The equipment effect should be
• * Non additive
• * Non adsorptive
10. GMP
GMP
Installation: For
For
Equipment
Equipment
ss
While installing equipment points mentioned
below should be considered:
Equipment should be located in such a way that
contamination of sub. By other materials is
minimized.
One equipment should be located at sufficient
distance from the other so do not get admixed
with each other.
All open mechanical belts and pulleys should be
covered with safety belts.
11. GMP
GMP
For
For
Equipment
Equipment
ss
Water and other utility service lines should be
so installed as to be easily accessible during all
phases of operation.
All pipes, tanks and jackets which handle
steam or coolants should be properly
insulated.
12. GMP
GMP
Cleaning and maintenance: For
For
Equipment
Equipment
ss
Purpose:
To remove product residue of previous product or
batch and to clean and sanitize the equipment for next
batch.
Equipment should be cleaned regardless of their size.
Larger equipment which are fixed or too heavy to
move should be cleaned on location.
Detachable parts and small equipments should be
taken to cleaning area assigned for the purpose.
13. GMP
GMP
For
For
Equipment
Equipment
ss
Written cleaning procedures or SOP should be
prepared for all the equipments.
These should be in the language that is understood by
the workers and be available in the section.
Cleaning procedures are different for dry product and
liquid tanks.
Tags with words like ‘equipment cleaned’, ‘cleaned’ or
‘ready for use’ can be used for clean equipment. Clean
equipment should be covered to protect from
contamination.
14. GMP
GMP
For
For
Equipment
Equipment
ss
Cleaning implements:
• scrubber, brush..
Washed with water
Antiseptic solution(0.5% cetrimide sol.)
Sterilize-70% IPA
Sanitizing agent(sodium hypochlorite, IPA)
Cover ends of clean tubing with polyethylene sheet
15. GMP
GMP
For
For
Equipment
Equipment
ss
A format which can be used as a guide for log
book is printed below:
M/s
Log book for cleaning and sanitization of
Date Time SOP no. Cleaned By Checked By
16.
17. GMP
GMP
Maintenance program: For
For
Equipment
Equipment
ss
Systematic and routine cleaning, adjustment, or
replacement of instrument and equipment parts
Performed periodically, daily, weekly, monthly
Example:
Cleaning optical lenses
Thermostat adjustments
Changing motor brushes
18. GMP
GMP
Function checks: For
For
Equipment
Equipment
ss
Monitoring of instrument to verify that your
equipment is working according to the
manufacturer’s specification
Performed periodically- daily, weekly, monthly
Performed after major instrument repair
Example:
Daily monitoring of temperatures
Checking wavelength calibration
Checking autoclave indicator paper
19. GMP
GMP
Weekly sterilization checks: For
For
Equipment
Equipment
The laboratory should develop a procedure for ss
the
weekly sterilization check using a biological
indicator
and keep detailed records of each check.
Weekly Sterilization Record
Sterilizer Date of Mfg. Mfg. Date Date Tester’s Sterilized Vial Control Vial Result
Location & Lot # plus 2 yrs. of Test initials Expected Expected Okay
expiration Results Results
(purple = neg) (yellow = gr)
20. GMP
GMP
For
For
Equipment
Equipment
ss
For the proper maintenance implementation
of maintenance program are necessary.
• Assign responsibility
– Oversight of all laboratory equipment
– Individual responsibilities
• Develop written policies and procedures
• Train staff
• Keep records
21. GMP
GMP
For
For
Equipment
Equipment
ss
Create a record for equipment inventory
Name, Model #, Serial #
Location in lab
Date purchased
Manufacturer and vendor contact information
Warranty, expiration date
Spare parts
For each piece of equipment:
Establish routine maintenance plan
Establish required function checks
Develop a list of spare parts
22. GMP
GMP
Documentation:
For
For
Equipment
Equipment
ss
A maintenance protocol that outlines
function verification and maintenance
activities
Develop a problem log record for each piece
of equipment (Important for future selection)
Date problem occurred, removed from service
Reason for breakdown or failure
Corrective action taken
Date returned to use
Change in maintenance or function checks
23. Electronic, mechanical and electronic GMP
GMP
For
For
equipments: Equipment
Equipment
s s
Automatic, mechanical, or electronic equipment or
other types of equipment, including computers, or
related systems that will perform a function used in
the manufacture, processing, packing, and holding of a
drug product.
If such equipment is so used, it shall 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.
24. GMP
GMP
For
For
Equipment
Equipment
ss
Appropriate controls shall be exercised over
computer or related systems to assure that
changes in master production and control
records or other records are instituted only by
authorized personnel.
Input to 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 all be based on the complexity and
reliability of the computer or related system.
25. GMP
GMP
For
For
Equipment
Equipment
ss
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 their automated processes.
Hard copy or alternative systems, such as duplicates,
tapes, or microfilm, designed to assure that backup
data are exact and complete and that it is secure from
alteration, inadvertent erasures, or loss shall be
maintained.
26. Stages: GMP
GMP
For
For
Equipment
Equipment
ss
Design and
Installation
specification
Ongoing operation Operation
27. GMP
GMP
For
For
Equipment
Equipment
ss
These four stages have been integrated into the
‘‘life cycle approach’’ which starts with the
identification of user requirements, continues
through the stages of development, installation,
validation, operation, and maintenance, and
ends only when the use of the system is
discontinued.
Revalidation should ideally only need to be
considered when there have been approved
changes to the system.
28. GMP
GMP
Reference: For
For
Equipment
Equipment
ss
Sidney H. Willig, “Good manufacturing Practices
for Pharmaceutical”, volume-109, Marcel Dekker
N.Y. Page No.65-75.
P.P.Sharma, “How to practice GMP’s”, 3rd edition,
Vandana Publication. Page no.152-155.
www.cde.gov/dls/ilq/cd/../module.ppt
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