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
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.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
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
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.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
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 of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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”
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
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)
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
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 of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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”
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
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)
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
Aseptic process is very critical in drug manufacturing , Facility along with the trained persons are very much important and there handling practices play a very crucial role in the sterility and integrity of the products. First we have to assure yourself before giving assurance to others.
MANUFACTURING OF PARENTRALS
1. Formulation and Raw Materials:
Concept: The process begins with the formulation of the parenteral drug, determining its composition and concentration.
Raw Materials: High-quality pharmaceutical-grade raw materials, including active pharmaceutical ingredients (APIs), excipients, and solvents, are selected based on their compatibility and purity.
2. Sterilization of Raw Materials:
Concept: Due to the sterile nature of parenteral products, all raw materials, including the API and excipients, must undergo rigorous sterilization.
Methods: Common sterilization methods include autoclaving, filtration, and aseptic processing to ensure aseptic conditions throughout the manufacturing process.
3. Manufacturing Process:
Preparation: The formulation is prepared, and various components are weighed and measured precisely.
Mixing: The ingredients are mixed under controlled conditions to achieve a homogeneous blend, ensuring uniform distribution of the API and other components.
Filtration: The solution is then filtered to remove any particulate matter and ensure clarity.
Filling: The sterile drug solution is filled into vials, ampoules, or other suitable containers in a controlled environment, maintaining sterility.
4. Sterilization of Final Product:
Terminal Sterilization: The final product, in its container, undergoes terminal sterilization methods like autoclaving or gamma irradiation to eliminate any microbial contamination that may have occurred during the manufacturing process.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Palestine last event orientationfvgnh .pptxRaedMohamed3
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.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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
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.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
2. Auditing of Microbiological lab:
“A service involving an independent review of an organization's records,
operations and procedures to evaluate for efficiency, effectiveness,
compliance and the existence of adequate internal controls to mitigate risks
to the achievement of the organization's objectives.”
Objectives:
1.Determine quality systems in place for microbiological control
2.Determine level of knowledge and capabilities of audited site
3.Determine if continuous improvement is part of culture
3. Six Principles of Efficient Auditing
Correct preparation
Correct types and frequencies of QC protocols and procedures
Correct documentation
Adherence to method requirements
Adherence to SOP procedures
Initial and continuing proficiency demonstrations
4. WHAT ARE RAW MATERIALS ?
All materials that used into the manufacturing of a finished bulk (even
though it may not be present in final product e.g. Certain solvents etc.)
and which are consumed by person using it are called as raw materials.
Raw materials can be either active drug or inactive substances.
E.g. Hard gelatin capsules: even though it is used to fill the blend of
medicine, it is not considered as package materials because it is
consumed by person using medicines.
5. AREA OF INTEREST IN BUILDING OF RAW MATERIAL:
1)Walls and Celling's:
Moulds are most commonly encountered microbes on walls celling’s,
particularly when poor ventilation, temperature, and relative humidity
control lead to high level of moisture.
Contamination may be excessive where damaged surfaces expose the
underlying plaster.
Surfaces should be smooth ,impervious and cleanable; damaged
surfaces should be repaired promptly.
6.
7. 3.DOORS ,WINDOWS AND FITTINGS :
These should be flush-fitting whenever possible.
Wood readily absorbs moisture and can generate high number of
moulds; where present, it should be sealed with a high –glass paint and
any surface damage repaired immediately.
4.EQUIPMENT:
The ability of bacteria to attach to surfaces such as stainless steel and
plastic and survive should not be under estimate.
Every piece of equipment has its own particular nooks and crannies
where microbiological contamination can reside; internal threads and
dead legs cause particular problem
8. 5.CLEANING OF EQUIPMENT:
Cleaned equipment can be readily re-contaminated before use .
The auditor should review :the quality water used in final rinsing stage
and how equipment is dried and stored to minimize the risk of
contamination by pseudomonas and other gram –negative bacteria.
6.PIPELINES:
Pipeline must be completely drainable to ensure that trapped fluid
does not provide a hospitable environment for growth of bacteria.
Internal surfaces should be smooth and polished to minimize pits
where microbes may lodge.
Joints and welds should be kept a minimum, since they may provide a
protective haven for a microorganism. Its sealed with lagging material.
If the protective outer seal is damaged then it may provide a rich
source for contamination.
9. RAW MATERIALS:
Raw materials pose a major contamination threat to the product and the
production environment, and warrant special attention from auditor.
Untreated raw material of natural origin contain an extensive and varied
microbial population ,including potentially pathogenic organisms, such as E.coli
and salmonella species,
In case of excessively high bio-burden , pre-treatment may be needed to reduce
the bio-burden to an acceptable level , using process such as heat filtration,
irradiation ,recrystallization from a biocides or where compatible ,ethylene
oxide gas.
Irrespective of the type raw material used, the auditor should confirm that the
material is provided by an ‘approved ‘supplier.
10. Confidence in the supplier ‘s manufacturing process and their quality
system, which have been challenged through audit.
Likewise the sampling program used should be satisfactory ,based upon
the nature of the raw material(natural /synthetic),the history and
performance of the supplier ,and end use of raw material.
Sampling procedure should be reviewed.
Reduce the risk of contamination both sample and bulk.
Sampling equipment should be dedicated and clean.
Samples should be properly trained in aseptic techniques.
Warehouse storage condition should also be reviewed: temperature
control should be satisfactory ;pest control should be effective; and
containers should be positioned so that they do not come into contact with
damp ,cold surfaces such as walls and floors.
11. Water:
Water is principle of raw material used in pharmaceutical industry.
When reviewing water systems usually as part of a ‘product based
audit', the auditor must establish quickly an understanding of the
system and how it performs.
Key facts to know include whether water is used directly manufacture
and which grades of water used.
Management and operational issues include who owns the system, its
complexity(one or multiple plants).
A schematic diagram of system should be provided.
12. MICROBIOLOGICAL RESULTS :
In establishing whether an adequate system of control operates ,data
from samples taken from user points over the past 6 to 12 months
should be reviewed noting user points sampled , the range of results
and underlying trend ,whether action and alert limits are visible and
appropriate, and whether trend analysis has been applied to improve
interpretation and reporting of results.
The time of monitoring should also be noted with reference to when
the system was sanitized.
Even in the event of zero counts, the microbiological sampling
practices and test procedures should be challenged .
13. PACKAGING MATERIALS:
Cardboard ,paperboard and pulp board, unless sealed or treated, can
provide a rich source of contamination particularly moulds and gram
positive bacteria, often as resistant spores.
Materials become moist through poor storage levels of water and
subsequently microbiological contamination can increase.
Material such as glass, synthetic rubbers, plastics and laminates have
minimal surface microbial counts.
However ,if stored with limited protection in dusty or damp
conditions and packed for transportation in cardboard boxes ,often on
damp ,dirty wooden pallets, they may contain moulds and bacterial
spores.
14. ESSENTIAL DOCUMENTS:
Validation documents relating to design qualification ,installation
qualification ,operational qualification and performance qualification
(DQ,IQ,OQ AND PQ) should be complete , available and current for
the water system concerned.
Only when this has been thoroughly reviewed and approved may any
microbiological considerations be addressed.
Protocol should be prepared and approved.
Final reports should have been completed, reviewed and approved
highlighting areas of non compliance together with justifications and
recommendations for corrective action.
15. EFFECTIVE VENTILATION:
The aerial route of contamination is common and can be
significantly reduced by an effective heating ventilation and air
conditioning system.
Humidity and Temperature control is important , since this not only
provides a pleasant working environment ,but also reduces the risk
of mould contamination.
16. CLEANING AND DISINFECTION:
Although routine sanitization of surfaces is key to controlling environmental
contamination ,its importance is often over looked.
The sanitization program and procedure should be reviewed to confirm the
frequency and precise method of cleaning and their scientific basis.
The cleaning records should confirm procedural compliance (when, where and by
whom).
The activity of any disinfectant used should be appropriate for the wide range of
environmental contaminants likely to be present.
The manufacturers instructions should be followed and fresh disinfectant solutions
should be made up before use.
Mops, sponges and cloths can provide an ideal environment for rapid and extensive
growth of water –bone organisms such as pseudomonas species.
Inadequately stored and maintained cleaning equipment can be highly efficient
vehicles for spreading micro-organisms throughout the environment.
