it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
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.
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.
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.
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
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
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”
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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.
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing 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.
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
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
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”
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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.
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing purpose.
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.
Introduction to Pharmaceutical Validation, Scope & Merits of Validation, Validation and calibration of Master plan, Hrs ICH & WHO guidelines for calibration and validation of
equipment's, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
This presentation was made to solely for students to make them aware/ understand basics of “Instrument Qualification/Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
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
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
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.
1. PRESENTED BY:
Mr. Ankush P. Jadhav & Miss. Tejashree R. Kedar
M. Pharm (PQA)
Email id: jadhavbrand@gmail.com,
.............tejashrikedar@gmail.com
1
QUALIFICATION OF MANUFACTURING EQUIPMENTS
4. INTRODUCTION
QUALIFICATION
• “It may be defined as the action of providing and documenting that equipment or
ancillary systems are properly installed, work correctly, and actually lead to the
expected results.”
• Qualification is the part of validation.
• Qualification have been grouped into four phases of qualification.
4
5. DESIGN QUALIFICATION
• Design qualification (DQ) defines the functional and operational specifications of
the equipment.
INSTALLATION QUALIFICATION
• The IQ process is intended to demonstrate that equipment meet all Specification,
installed properly and supporting program ( SOP, Maintenance sheet)
are in place.
5
6. OPERATIONAL QUALIFICATION
• OQ is the process of demonstrating that an instrument will function according to
its operational specification in selected environment.
PERFORMANCE QUALIFICATION
• It refers to establishing by objective evidence that the process consistently
produces a product which meets all predetermined requirements.
6
7. 1) DRY POWDER MIXER
DESIGN QUALIFICATION (DQ)
• Design qualification (DQ) defines the functional and operational specifications of
the instrument.
Design qualification Of it includes :
• Facility layout, Utility requirements and specifications.
• Required capacity of the Mixer.
• Type of materials to be mixed, Mixing time
7
8. INSTALLATION QUALIFICATION (IQ)
• The IQ process is intended to demonstrate that the Dry Powder Mixer meet all
specification, installed properly and supporting program ( SOP, Maintenance sheet )
are in place.
The IQ includes following checks :
• Supplier or manufacturer name & address shall be checked.
• Equipment name, make & model no. shall be noted down.
• Check Gear Box, Control Panel, Buttons, Driving Motor 8
9. OPERATIONAL QUALIFICATION (OQ)
• OQ is the process of demonstrating that an instrument will function according to
its operational specification in selected environment.
OQ includes following checks :
• On/ off Switch
• Gross Capacity
• RPM
9
10. PERFORMANCE QUALIFICATION (PQ)
• Load the material into the mixer
• Start the mixer and rotate it for the time as mentioned in the BMR
• After completion of mixing switch off the mixer & Separate out material
• Collect the sample as per sampling procedure
• Send the samples to QC departmnet for Content Uniformity, Bulk Density & Sieve
analysis
10
11. 2) FLUID BED DRYERS
DESIGN QUALIFICATION (DQ)
It Involves the Functional & Operational Specification of Dryers
• Facility Layout
• Utility Requirement i.e. Vertical or Horizontal
• Required Capacity Of The Dryer
11
12. INSTALLATION QUALIFICATION (IQ)
• Equipment Should Comply With The Original Purchase Specification
• Utility Installation, Operating Manual
• Check for any physical damage
• Verify electrical Supply
• Inlet Air installation
• SOP, Mfg. / Supplier Details
12
13. OPERATIONAL QUALIFICATION (OQ)
• Check Alarm control
• Speed Of Air
• Moisture Content
• Tap Density
• Particle Size Distribution
• Heat Distribution study
13
14. PERFORMANCE QUALIFICATION (PQ)
• The system is installed with Design specification, Mfg. Recommandations &
cGMPs.
• Run The Trial batch during operation and there should not be change in the Size,
Shape, Surface Characteristics.
14
15. 3) CAPSULE FILLING MACHINE
INSTALLATION QUALIFICATION (IQ)
The Installation Qualification will confirm details :
• The engineering specifications
• cGMP guidelines and requirements
• The purchase order no. & date shall be checked
• The accessories & their spare parts if any shall be checked as per purchase order
• Equipment name, make & model no. shall be recorded
15
16. OPERATIONAL QUALIFICATION (OQ)
• Before initiating OQ ensure that SOP for operation and Cleaning of Capsule
Filling Machine is available.
• The operation of indicators, controls and alarms is verified
• Oil leaks that could contaminate the process are observed
• Check the capsule filler to the required specifications
16
17. PERFORMANCE QUALIFICATION(PQ)
• PQ activities demonstrates and documents that the equipment is able to perform its
intended functions.
• To ensure that the quality and purity of the product is maintained
• Record the number of damaged capsules
• Capsules should be tested for weight uniformity
• Capsules batches should be tested for content uniformity
17
18. 4) TABLET COMPRESSION MACHINE
INSTALLATION QUALIFICATION (IQ)
The Installation Qualification Will Confirm Details :
• Model Number
• Serial Number
• Location Of The Equipment
• The Accessories & Their Spare Parts Checked As Per Purchase Order
• Any Deviation Observed Should Be Informed To The Supplier/Manufacturer
18
19. OPERATIONAL QUALIFICATION (OQ)
Equipment Can Operate With Specified Limits
• Upper Punch Test
• Lower Punch Test
• Tablet Press Speed
• Tablet Press Rotation Direction
19
20. PERFORMANCE QUALIFICATION(PQ)
• PQ activities demonstrates and documents that the equipment is able to perform its
intended functions.
• To ensure that the quality and purity of the product is maintained
• Record the number of damaged tablets
• Tablet should be tested for weight uniformity, Hardness test
• Tablet batches should be tested for content uniformity
20
21. CONCLUSION
• Evidence that equipment operates consistently within established limits.
• To ensure that the quality and purity of the product is maintained.
• Performed in stages : Design, Installation, Operation, Performance,
Requalification
• Information evaluated independently by Quality Assurance.
21
22. REFERENCE
• Berry I.R., and Nash R.A., “Pharmaceutical Process validation” second edition,
revised and expanded; Marcel Dekker series; 83-110.
• Equipment Qualification & Validation of Autoclave, Dry Heat Sterilization And
Membrane Filtration.
• Manohar A. Potdar “Pharmaceutical Quality Assurance” Nirali Publications, 6th
edition, 2017.
• Sawant R., Hapse S., “Fundamentals of Quality Assurance Techniques” 2nd
edition, Career Publications, May 2016.
22
