The document discusses in-process quality control for pharmaceutical manufacturing. It outlines that the purpose of in-process quality control is to ensure batch uniformity and integrity. It describes that procedures for in-process quality control should specify in-process controls and limits, required tests and examinations, and sampling procedures for each batch during both manufacturing and packaging operations. The document provides examples of key process parameters that should be evaluated and optimized as part of in-process quality control.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
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.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
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.
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
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
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
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
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
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
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
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
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.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
ANTI HYPERTENSIVE AGENTS [MEDICINAL CHEMISTRY] BY P.RAVISANKAR, HYPERTENSION,...Dr. Ravi Sankar
ANTI HYPERTENSIVE AGENTS [MEDICINAL CHEMISTRY] BY P.RAVISANKAR, HYPERTENSION,TYPES,CAUSES OF HYPERTENSION, CLASSIFICATION, MECHANISM OF ACTION, SAR, ACE INHIBITORS, ARB , DIURETICS(WATER PILLS), TIPS TO STOP SILENT KILLER.
BY P. RAVISANKAR, VIGNAN PHARMACY COLLEGE, VADLAMUDI, GUNTUR,A.P, INDIA.
In Process Quality Control System (IPQC) for Solid Dosages Form (Tablets)Gaurav kumar
This presentation pertains to the in-process tests performed during the manufacturing process of the solid dosages form (tablets).
The presentation covers the methods and the permissible limits for the tests performed.
These tests are of great importance as these not only ensure quality product but also upholds the cGMP.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
Key Components of Pharmaceutical QbD, an IntroductionSaurabh Arora
In the past few years, US FDA has implemented the concepts of Quality by Design (QbD) into its approval processes. FDA is insisting that quality should be built into a product with an understanding of the product and process, through development and manufacturing. QbD is a successor to the "quality by QC" (or "quality after design") approach.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
2. In- process quality control
Purpose:
To insure batch uniformity and integrity of drug product
Procedures for I.P.Q.C. should describe:
• In process controls and their limits
• Tests and examinations to be conducted
• Sampling procedures of each batch
I.P.Q.C.:
• For manufacturing operations
• For packaging operations
3. Scanning/Vectorization
Option
Transfer Verify Data Production Steps
& Convert Completeness In-process QC Inspection
Independent QC Inspection
Verify Image Transform Process Decision Point
& Vector Coordinates Main Process Flow
Quality Interactive QC Loop
Review
Scan/ Transform
Vectorize Statistics
Manuscript
Prep Edits
Identify & Positional Accuracy,
Manuscript Automate Pass/
Correct Completeness and
Verification Maps Fail
Gross Errors Topology testing
Basic Production Flow with
Manual Common Quality Control
Digitizing
Checks
4. Edits
Positional Accuracy,
Pass/ Attribute
Completeness and
Fail Coding
Topology testing
Manual
Attribute
Production Steps
Testing
In-process QC Inspection
Independent QC Inspection
Process Decision Point
Main Process Flow Pass/
Interactive QC Loop Edits
Fail
Edgematch Transformation Coordinate Automated
Edgematch
Verification Verification Transformations QC Checks
Final
Sign-off Basic Production Flow with
Common Quality Control Checks
Delivery
5. Independent Inspection
Will always find errors that
elude the data processor.
In-Process Inspection
Useful for controlling simple
data processing actions.
6. General Guidelines
for Cost-Effective Error Checking
Re-work is always more costly
than doing it right the first time.
Check everything once, and then
concentrate on maintaining data
integrity through the remaining
processes.
Minimize the amount of materials
that have to be handled.
6
7. QUALITY MANAGEMENT
Data Quality Control is Process Control
Documentation
Record existence of anomalous conditions
Maintain a complete data dictionary
(including data extraction rules)
Always provide staff (or vendor) with
detailed written procedures plus diagrams
describing graphic decision rules
7
8. QUALITY MANAGEMENT
Data Quality Control is Process Control
Communication
Develop formal mechanisms
(i.e., standard symbols/colors for errors)
Conduct frequent coordination and status
meetings
Provide honest opinions and feedback
9. IN-PROCESS EVALUATION
Process parameters should be evaluated
and optimized.
For example : Mixing
Order of addition
Mixing speed
Mixing time
Rate of addition etc.,
10. Chemical weigh sheet
Identify the chemicals
Its quantity
The order of using
The sampling directions
Process specifications
Should be in understandable language
In process and finished product
specifications
Proper documentation required
11. GMP CONSIDERATIONS
Process Validation
Regular process review and
revalidation
Relevant written Standard Operating
Procedures
Equipment Qualification
Regularly scheduled preventive
maintenance
12. Validated cleaning procedures
An orderly arrangement of equipment so as
to ease material flow and prevent cross-
contamination
A well defined technology transfer system
The use of competent, technically qualified
personnel
Adequate provision for training of personnel
13. MATERIAL/POWDER HANDLING
Two primary concerns : Achieving reliable
flow and maintaining blend uniformity.
Segregation leads to poor product uniformity.
Handling system :
- Must deliver the accurate amount of the
ingredient
- Material loss should be less
- There should be no cross contamination
14. Avoiding segregation …..
Modify the powder in a way to reduce its inherent
tendency to segregate
Change the particle size such that the active
segregation mechanism becomes less dominant
Change the cohesiveness of the powder such that
the particles in a bed of powder are less likely to
move independent of each other
Modify the equipment to reduce forces that act to
segregate the powder
Change the equipment to provide remixing
15. DRY BLENDING
Dry blend should take place in
granulation vessel
Larger batch may be dry blended
and then subdivided into multiple
sections for granulation.
All ingredients should be free of
lumps otherwise it causes flow
problems.
Screening and/or milling of the
ingredients prior to blending usually
makes the process more reliable
and reproducible.
16. GRANULATION
• The weight of the material and the
shear forces generated by
granulation equipment.
• The use of multifunctional processors
(significant in terms of space and
manpower requirements).
• Viscosity of the granulating solution.
17. FLUIDISED BED GRANULATIONS
Process inlet air temperature
Atomization Air Pressure
Air Volume
Liquid Spray Rate
Nozzle Position and Number of
Spray Heads
Product and Exhaust Air
Temperature
Filter Porosity
Cleaning Frequency
Bowl Capacity
19. Hot Air Oven
Air flow
Air Temperature
Depth of the granulation on the trays
Monitoring of the drying process by the
use of moisture and temperature probes
Drying times at specified temperatures
and air flow
rates for each product
20. Fluidized Bed Dryer
Optimum Load
Air Flow Rate
Inlet Air Temperature
Humidity of the Incoming Air
21. PARTICLE SIZE REDUCTION
Sizing plays a key role in achieving uniformity.
There are two ways of sizing : Particle size separation
and Particle size reduction.
Major Factor – Feed rate of the material.
As the feed rate is increased so is residence time
with in the chamber of the equipment which in turn
results in finer distribution.
During scale up, overhead feeding equipment is
incorporated to mimic large scale production.
22. BLENDING
Blender loads
Blender size
Mixing speed
Mixing time
Bulk density of the raw material (considered
in selecting blender and in determining
optimum load)
Characteristics of the material
24. Dry Blending and Direct Compression
The order of addition of components to the blender
The blender load
The mixing speed
The mixing time
The use of auxiliary dispersion equipment within the
mixer
The mixing action
Compression force
25. Slugging (Dry Granulation)
Forces used for slugging operation
The diameter of the punches
Subsequent sizing and screening operations
26. GRANULATION HANDLING
AND FEED SYSTEM
Evaluation of vacuum automated
handling systems and mechanical
systems
Segregation : Due to static charges
built up due to vacuum can alter
material flow property
The effect of above system on the
content uniformity of the drug and on
the particle size
27. COMPRESSION
Press speed
Handling and compression characteristics
(in the selection of a tablet press)
Die filling rate
Flow rate of granules
Induced die feed systems (for high speed
machines) – speed of feed paddles
The clearance between the scraper blade
and the die table
Design and condition of the punches
29. Pan and Fluidized Coating
Optimum tablet load
Operating tablet bed temperature
Drying airflow rate and temperature
The solution application rate
The size and shape of the nozzle aperture
(for airless sprayer)
The atomizing air pressure and the liquid
flow rate (for air atomized sprayers)