This document discusses the qualification of manufacturing equipment. It explains that equipment qualification is necessary to ensure equipment works correctly and produces reliable results. There are four types of qualification: design, installation, operational, and performance. Design qualification defines equipment specifications. Installation qualification confirms proper installation. Operational qualification verifies equipment functions as specified. Performance qualification demonstrates consistent performance under routine use. The document then provides details on specific qualification procedures for dry powder mixers and fluidized bed dryers.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
Process validation presentation for finished goods, we will able to follow the activity in anywhere in Pharmaceuticals. Process validation is one of the main part of Quality Assurance,
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
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2. Equipment Qualification:
Equipment is an collective analytical measurement assembled to perform a mechanical process.
Without an equipment we cannot manufacture a product.
So, EQ ( Equipment Qualification) is action of proving that an equipment works correctly and
accordingly so, as to give the accurate and reliable result.
If equipment is validated we can ensure that our product is of best quality.
So term validation and qualification are interlinked to each other.
QUALIFICATION:
Qualification is a process of proving and documenting that an equipment or its ancillary
system are installed properly, work accordingly, and lead to actual expected result.
So, term QUALIFICATION is categorised into four different parts as followed:
I. Design Qualification
II. Installed Qualification
III. Operational Qualification
IV. Performance Qualification.
3. WHY IT IS REQUIRED?
To increased throughput
For reduction in rejections and reworking
For reduction in utility costs
For avoidance of capital expenditures
Fewer complaints about process-related failures
Reduced testing in-process and in finished goods
More rapid and reliable start-up of new equipment
Easier scale-up from development work
Easier maintenance of equipment
Improved employee awareness of processes
More rapid automation
4. Who should do Equipment Validation? :
The vendor or the user has the ultimate responsibility for the accuracy of the analysis
results and also for equipment qualification.
DQ should always be done by the user.
While IQ for a small and low cost instrument is usually done by the user, IQ for large,
complex and high cost instruments should be done by the vendor.
OQ can be done by either the user or the vendor.
PQ should always be done by the user because it is very application specific, and the
vendor may not be familiar with these.
As PQ should be done on a daily basis, this practically limits this task to the user.
5. Design Qualification (DQ):
"Design qualification (DQ) defines the functional and operational specifications of the
instrument and details for the conscious decisions in the selection of the supplier".
The steps that should be considered for inclusion in a design qualification. Description of the
analysis problem, Description of the intended use of the equipment, Description of the intended
environment, Preliminary selection of the functional and performance specifications,
Preliminary selection of the supplier, Final selection of the equipment, Final selection of the
supplier, Development and documentation of final functional and operational specifications,
Installation Qualification (IQ):
“Installation qualification establishes that the instrument is received as designed and specified,
that it is properly installed in the selected environment, and that this environment is suitable for
the operation and use of the instrument.”
The qualification involves the coordinated efforts of:
The vendor.
The operating department.
The project team (which provide input into the purchase, installation, operation and
maintenance of the equipment).
6. Operational Qualification (OQ):
"Operational qualification (OQ) is the process of demonstrating that an instrument will function
according to its operational specification in the selected environment”.
The proper operation of equipment is verified by performing the test functions specified in the
protocol.
A conclusion is drawn regarding the operation of equipment after the test functions are checked
and all data has been analyzed.
Following are the contents of equipment operation qualification:
1. Application S.O.P’s
2. Utilization List
3. Process Description
4. Test Instrument Utilized To Conduct Test
5. Test Instrument Calibration
6. Critical Parameters
7. Test Function (List)
8. Test Function Summaries
7. Performance Qualification (PQ):
"Performance Qualification (PQ) is the process of demonstrating that an instrument
consistently performs according to a specification appropriate for its routine use ".
PQ should always be performed under conditions that are similar to routine sample
analysis.
PQ should be performed on a daily basis or whenever the equipment is being used.
In practice, PQ can mean system suitability testing, where critical key system
performance characteristics are measured and compared with documented.
8. LIST OF MANUFACTURING EQUIPMENT
USED MORE OFFENLY:
Dry powder mixer
FBD ( Fluidised Bed Dryer)
Tablet Compression Machine
Autoclave
Capsule filing machine
Homogenizer
9. Dry Powder Mixer:
The mixing of dry ingredient that is excipient and API is critical step in
solid dosage form preparation that affect content uniformity at great extent.
Types of Powder Blender:
V cone Blender
Double Cone Blender
Drum mixture
Ribbon Blender
Conical Screw Mixer
Tumble Blender.
10. URS for Powder Blender:
Operating criteria must be adequate
Spare should be available
Easy maintenance
Equipment should not disseminate dust
Low cost
Non reactive surfactant
Capacity
Mixing speed
11. Installation Qualification:
Detail of Equipment:
Equipment name, made by and model no. shall be noted down.
Location for installation equipment shall be checked
Utilities required shall be listed down
Any deviation observed while following above procedure should be informed
for corrective action.
Installation Procedure:
After checking all the specifications as mentioned in the selection criteria,
service engineer shall verify the equipment.
Authorized validation team shall carry out installation checks.
12. Sr
no.
Description Specification Method of
Evaluation
Observation
1 Equipment type Visual inspection
2 Surface Finish Visual Inspection
3 Driving motor Visual Inspection
4 Gear box Visual Inspection
5 Control panel
and button
Visual Inspection
6 Dimension Measure tape
13. Operational qualification:
After completions of successful installation qualification initiate the actual operation of to ensure
that machine is operating within specification.
Check the operation qualification parameters against their specifications.
Document the deviation details
The Quality head and the department head shall decide whether deviation is acceptable or not.
Sr
no
Description Specification Method of Evaluation Observation
1 On/off switch Lift the On switch and
ensure that power supply is
as required by proper
visualizing either
drum/cone started to rotate
or not.
2 RPM (Revolution
per minute)
Measure the actual RPM
using stop watch
3 Gross Capacity Fill the drum/cone with
potable water and record
14. Performance qualification
Load the materials to be mixed in the mixer
Start the mixer and rotate it for the time as mentioned in the BMR.
After completion of mixing switch OFF the mixer and separate out the drum.
Collect the sample as per sampling procedure.
Send the samples to Quality control dept. for content uniformity, bulk density
and sieve analysis
15. Fluid Bed Dryer:
Fluid bed drying is most widely used technique for drying pharmaceutical powders and
granulation.
The direct contact between particles and air/gas is possible in fluid bed system.
Here any type of inert gas or air is used.
They can be designed in either batch or continuous type fluid bed dryer
PRINCIPLE:
In fluidized bed dryer, hot air is passed at high pressure through a perforated bottom of
the container containing granules to be dried.
The granules are lifted from the bottom and suspended in the stream of air.
This condition is called fluidized state.
16. FBD DESIGN QUALIFICATION:
The goal is to perform something similar to a risk analysis and to check the design
documents of a technical system to ensure that then fulfils the user requirements.
In fluidized bed dryer the design of the instrument should be:
Should occupy small place
Based on our requirement we can go for horizontal or vertical.
The bed which contain the material should be dried in conical shape or less some particles
may retain as such at the corners
All technical considerations should be kept in mind while doing the design.
17. Installation Qualification (IQ):
Installation Qualification for fluidized bed dryer include the following steps:
Verifying the approved purchase order.
Check the manufacturer and supplier.
Check for any physical damage.
Verify that the utilities required are available.
User manual
Maintenance manual.
List of charge parts.
Electrical drawings.
Specially for FBD:
Air temperature distribution.
Inlet air installation
Microbiological quality of the inlet air.
Influence on weather on inlet air conditions.
18. Operational Qualification (OQ):
Documented verification that the system performs as intended throughout all anticipated operating
ranges, Some of them include:
Verify alarm control.
Verify that all switches and push button are functioning properly.
Heat should distributed equally through out the system.
Do the tests for uniform distribution of air.
Establish training program for relevant stages.
Operate all parts at their low, medium, and high level.
Run three batches of each product and analyze for:
Speed of air (velocity of air).
Active ingredients homogeneity.
Moisture content.
Particle size distribution.
Percentage fines.
Tap density.
Based on this data we can fix drying end points for each process.
19. Performance Qualification (PQ):
PQ means to check what we want actually for that particular process from the equipment, what
processes are to be monitored.
Inlet air speed.
Quality of air.
Uniform distribution of air.
Mixing of air with temperature.
Run the trail batch during operation and there should not be any change in the
Size
Shape
Surface characteristics.