The document discusses auditing of a microbiological lab. It covers objectives of the audit such as determining quality systems, knowledge and capabilities, and continuous improvement. It also discusses six principles of efficient auditing including preparation, quality control protocols, documentation, and proficiency. Key areas of the lab that are audited are described such as walls, equipment, piping, raw materials, water systems, packaging materials, cleaning and disinfection. Microbiological results are reviewed to ensure adequate control systems.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
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
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
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
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.
Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing purpose.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
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.
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
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
Qualification of Tablet Compression Machine.pptxDhruvi50
Tablet Compression Machine
Principle of Tablet Compression Machine
Construction of Tablet Compression Machine
Working of Tablet Compression Machine
Qualification of Tablet Compression Machine
Installation Qualification
Operational Qualification
Performance Qualification
References
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
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.
Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing purpose.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
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.
Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
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.
HEAP SORT ILLUSTRATED WITH HEAPIFY, BUILD HEAP FOR DYNAMIC ARRAYS.
Heap sort is a comparison-based sorting technique based on Binary Heap data structure. It is similar to the selection sort where we first find the minimum element and place the minimum element at the beginning. Repeat the same process for the remaining elements.
Understanding Inductive Bias in Machine LearningSUTEJAS
This presentation explores the concept of inductive bias in machine learning. It explains how algorithms come with built-in assumptions and preferences that guide the learning process. You'll learn about the different types of inductive bias and how they can impact the performance and generalizability of machine learning models.
The presentation also covers the positive and negative aspects of inductive bias, along with strategies for mitigating potential drawbacks. We'll explore examples of how bias manifests in algorithms like neural networks and decision trees.
By understanding inductive bias, you can gain valuable insights into how machine learning models work and make informed decisions when building and deploying them.
A review on techniques and modelling methodologies used for checking electrom...nooriasukmaningtyas
The proper function of the integrated circuit (IC) in an inhibiting electromagnetic environment has always been a serious concern throughout the decades of revolution in the world of electronics, from disjunct devices to today’s integrated circuit technology, where billions of transistors are combined on a single chip. The automotive industry and smart vehicles in particular, are confronting design issues such as being prone to electromagnetic interference (EMI). Electronic control devices calculate incorrect outputs because of EMI and sensors give misleading values which can prove fatal in case of automotives. In this paper, the authors have non exhaustively tried to review research work concerned with the investigation of EMI in ICs and prediction of this EMI using various modelling methodologies and measurement setups.
Hierarchical Digital Twin of a Naval Power SystemKerry Sado
A hierarchical digital twin of a Naval DC power system has been developed and experimentally verified. Similar to other state-of-the-art digital twins, this technology creates a digital replica of the physical system executed in real-time or faster, which can modify hardware controls. However, its advantage stems from distributing computational efforts by utilizing a hierarchical structure composed of lower-level digital twin blocks and a higher-level system digital twin. Each digital twin block is associated with a physical subsystem of the hardware and communicates with a singular system digital twin, which creates a system-level response. By extracting information from each level of the hierarchy, power system controls of the hardware were reconfigured autonomously. This hierarchical digital twin development offers several advantages over other digital twins, particularly in the field of naval power systems. The hierarchical structure allows for greater computational efficiency and scalability while the ability to autonomously reconfigure hardware controls offers increased flexibility and responsiveness. The hierarchical decomposition and models utilized were well aligned with the physical twin, as indicated by the maximum deviations between the developed digital twin hierarchy and the hardware.
ACEP Magazine edition 4th launched on 05.06.2024Rahul
This document provides information about the third edition of the magazine "Sthapatya" published by the Association of Civil Engineers (Practicing) Aurangabad. It includes messages from current and past presidents of ACEP, memories and photos from past ACEP events, information on life time achievement awards given by ACEP, and a technical article on concrete maintenance, repairs and strengthening. The document highlights activities of ACEP and provides a technical educational article for members.
CHINA’S GEO-ECONOMIC OUTREACH IN CENTRAL ASIAN COUNTRIES AND FUTURE PROSPECTjpsjournal1
The rivalry between prominent international actors for dominance over Central Asia's hydrocarbon
reserves and the ancient silk trade route, along with China's diplomatic endeavours in the area, has been
referred to as the "New Great Game." This research centres on the power struggle, considering
geopolitical, geostrategic, and geoeconomic variables. Topics including trade, political hegemony, oil
politics, and conventional and nontraditional security are all explored and explained by the researcher.
Using Mackinder's Heartland, Spykman Rimland, and Hegemonic Stability theories, examines China's role
in Central Asia. This study adheres to the empirical epistemological method and has taken care of
objectivity. This study analyze primary and secondary research documents critically to elaborate role of
china’s geo economic outreach in central Asian countries and its future prospect. China is thriving in trade,
pipeline politics, and winning states, according to this study, thanks to important instruments like the
Shanghai Cooperation Organisation and the Belt and Road Economic Initiative. According to this study,
China is seeing significant success in commerce, pipeline politics, and gaining influence on other
governments. This success may be attributed to the effective utilisation of key tools such as the Shanghai
Cooperation Organisation and the Belt and Road Economic Initiative.
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. AREAOF 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 ,WINDOWSAND 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. RA
W 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).
▶ Aschematic diagram of system should be provided.
12. MICROBIOLOGICALRESULTS :
▶ 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. ESSENTIALDOCUMENTS:
▶ Validation documents relating to design qualification ,installation
qualification ,operational qualification and performance qualification
(DQ,IQ,OQAND 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. CLEANINGAND 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.