During the audit, information relevant to the objectives, scope and criteria, including information on interfaces between functions, activities and processes, should be collected by appropriate sampling and should be verified.
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”.
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
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
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”.
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
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
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
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.
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
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.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
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.
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
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.
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
CIA part 1 essentials of internal auditingariundalai1
The Institute of Internal Auditors (The IIA) uses the International Professional Practices Framework (IPPF) to organize its authoritative guidance in a manner that is readily accessible. The IPPF, sometimes called the “Red Book,” is intended to help practitioners and stakeholders throughout the world respond to the expanding market for high-quality internal auditing.
Internal audit means a continuous critical review of financial and operating matters of a business. In other words, we can say that the audit of a business conducted by the business for a continuous basis. Internal audit is done by the internal staff appointed particularly for the audit purposes. These are called internal auditors.
This is a presentation under the course ENTREPRENEURSHIP DEVELOPMENT AND BUSINESS COMMUNICATION for UG STUDENTS of State Agricultural Universities.
Uploaded by Jayanta Kumar Dutta, Assistant Professor, Department of Extension Education, AAU, Jorhat, Assam
7 Steps to Conducting a Financial Audit | The Enterprise WorldTEWMAGAZINE
Overview of the financial audit process: 1. Preparing for the Audit 2. Assessing Internal Controls 3. Gathering and Reviewing Financial Data 4. Testing Financial Transactions and Balances 5. Summarizing Findings and Preparing Audit Reports 6. Post-Audit Follow-Up 7. Wrapping up
Similar to CHAPTER-1 Information Gathering and Administration.pdf (20)
Mass Spectrometry (MS) is an analytic technique used to determine the relative masses of molecular ions and fragments by calculating the degree of deflection of charged particles in a magnetic field.
It provides a great deal of information with very small amount of samples.
MS Fragmentation Process and Application of MS.pdfDr. Dinesh Mehta
Fragmentation process:
Bombardment of molecules by an electron beam with energy between 10-15ev usually results in the ionization of molecules by removal of one electron (Molecular ion formation).
Mass Spectrometry (MS) is an analytic technique used to determine
the relative masses of molecular ions and fragments by calculating the
degree of deflection of charged particles in a magnetic field.
It provides a great deal of information with very small amount of samples.
MS Fragmentation Process and Application of MS.pdfDr. Dinesh Mehta
Bombardment of molecules by an electron beam with energy
between 10-15ev usually results in the ionization of molecules by
removal of one electron (Molecular ion formation).
Unlike a spectrometer (which is any instrument that can measure the
properties of light over a range of wavelengths), a spectrophotometer
measures only the intensity of light as a function of its wavelength.
ISO defines the audits as “systematic, independent and documented process for obtaining audit evidence and evaluating them objectively to determine the degree to which the verification criteria are met.”
A process audit is an examination of results to determine whether the activities, resources and behaviour that cause them are being managed efficiently and effectively.
A process audit is not simply following a trail through a department from input to output - this is a transaction audit.
CHAPTER-1 Management Audit and Planning procedure.pdfDr. Dinesh Mehta
Audits are conducted to ascertain the validity and reliability of the information; also to provide an assessment of the internal control of a system. It provides management with information on the efficiency with which the company controls the quality of its processes and products
The versatile instrument is used to isolate unknown compounds from a HPTLC/TLC plate and transfer them into a mass spectrometer for identification or structure elucidation.
The aim of the coupling is to obtain an information-rich detection for both identification and quantification compared to that with a single analytical technique.
Benchmarking is defined as a technique in which an organisation compares its performance to that of 'best in class' organisations, discovers how other organisations achieve the levels they do, and uses that information to improve its own performance.
The hyphenated technique is a combination or coupling of two analytical techniques with the help of a proper interface.
The aim of the coupling is to obtain an information-rich detection for both identification and quantification compared to that with a single analytical technique.
Hyphenated techniques have received ever-increasing attention as the principal means to solve complex analytical problems.
Hyphenated techniques are widely used in chemistry and biochemistry and used for both quantitative and qualitative analysis of unknown compounds in complex natural product extracts or fraction and estimation of protein samples also.
Hyphenated technique is a combination or coupling of two analytical techniques with the help of proper interface.
In this presentation Hyphenated techniques-LC-MS/MS, GC-MS/MS, HPTLC-MS has been discussed
Comparing Evolved Extractive Text Summary Scores of Bidirectional Encoder Rep...University of Maribor
Slides from:
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Track: Artificial Intelligence
https://www.etran.rs/2024/en/home-english/
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
This presentation explores a brief idea about the structural and functional attributes of nucleotides, the structure and function of genetic materials along with the impact of UV rays and pH upon them.
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
Spectroscopy is a branch of science dealing the study of interaction of electromagnetic radiation with matter.
Ultraviolet-visible spectroscopy refers to absorption spectroscopy or reflect spectroscopy in the UV-VIS spectral region.
Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
What is greenhouse gasses and how many gasses are there to affect the Earth.moosaasad1975
What are greenhouse gasses how they affect the earth and its environment what is the future of the environment and earth how the weather and the climate effects.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
2. INFORMATION GATHERING
Information is simply the facts or knowledge provided or learned.
It can be tacit, in people's heads, or explicit, in documents-
electronic or hard copy.
During the audit, information relevant to the objectives, scope
and criteria, including information on interfaces between
functions, activities and processes, should be collected by
appropriate sampling and should be verified.
Only verifiable information can be audit evidence which must
be recorded
Audit evidence:
It is any information used by the auditor to determine if the
audited information is in accordance with the established
criteria and to arrive at the conclusions on which the audit
opinion is based. Internal Audit evidence includes any data,
information, process flows, vouchers, bills, memos, contracts or
transactions.
Methods of gathering audit information:
3. There are six basic methods of gathering information during an
audit. Depending on the type of information that needs to be
obtained, the Internal Auditor will need to determine which
method, or combination of methods, should be used.
Figure: Criteria adopted to collect Information
1. Interviews:
Interviewing is a powerful data collection technique, which
works well on its own and is often used to support other
techniques, such as observation.
The interviewee’s insights can guide the Internal Auditor’s
decisions about what to observe.
4. The most important thing to remember when interviewing is to
always talk to the right person, as it can save a lot of time and
confusion.
Communication is a key element to the success of any audit. The
more effectively the Internal Auditor interviews personnel, the more
useful information will be gathered.
Inspections:
When inspecting something, it is good practice to start with
general observations and then proceeding to the more specific
elements.
First, the Internal Auditor will have a good overall look around
the facility and then examine specific items more closely,
noting anything that does not seem quite right.
It is important to ask questions throughout the inspection. If a
problem is found, the Internal Auditor must investigate (dig
deeper) to explore the extent of the finding.
2. Reviewing documents:
Documents should be clear regardless of who reads them.
Details vary but, in general, every document should carry a
title, an owner and a revision status. If any of this information
is missing, the Internal Auditor should ask why.
The revisions noted should be checked against the master
record. Changes must be authorized, signed and dated by an
authorized person.
5. However, one sample taken in one given period of time is
usually not enough to form accurate conclusions. Another
important aspect of record keeping is clarity.
3. Observations:
The simplest way to check how a process works is to observe
it in action.
Observing a routine activity for a couple of hours can give the
Internal Auditor the opportunity to see how something is done
under normal circumstances.
He or she should ask questions about what they see, making
sure at all times not to interfere with the processes they are
observing, as that may cause the personnel not to carry out
their tasks as they usually do.
4. Vertical tracking:
This method is also referred to as “vertical auditing” and
consists of following a specific development from the
beginning until the end, simultaneously checking all the
records that are produced in the process.
Applying the vertical tracking technique can lead the Internal
Auditor to areas that were not initially part of the scope, but it
does facilitate a bigger picture view, as this allows the Internal
Auditor to see how the various parts of a given program work
together
6. 5. Exercises:
The aim of an exercise is to test something that is usually done
at the facility as part of the routine. However, the Internal
Auditor gets to pick the time and the circumstances for the test.
The subject of testing can be the personnel, the program, or the
equipment. An Internal Auditor should not run an exercise
without the knowledge and cooperation of the auditee.
Doing so is likely to have negative consequences as
unannounced actions may breach certain facility specific rules
or regulations which the Internal Auditor is unaware of.
A good Internal Auditor must have his or her own efficient way
of taking notes. This is an extremely important part of the job that
cannot be neglected. Notes must get reviewed and refined along
the way.
ADMINISTRATION:
The internal audit team must have the confidence and trust of the
key stakeholders it works with and be seen as a credible source of
assurance and advice.
This confidence should not be assumed and can only be
established and maintained by having an effective working
relationship, by delivering high quality and timely advice and
internal audit reports that are seen to be contributing directly to
assisting the organisation to meet its responsibilities.
7. The key stakeholders of internal audit are:
1. Chief Executive
2. Board of Directors
3. Audit Committee
4. Senior management
5. External auditor
6. Other reviewers
1. Chief Executive:
While internal audit reports functionally to the Audit
Committee, it is important that the Head of Internal Audit has
direct access, as and when required, to the Chief Executive.
Organisations today, recognize the advantages in making the
Head of Internal Audit directly accountable to the Chief
Executive. This not only sends a clear signal about the
importance of the internal audit function, it also facilitates
regular contact between the Chief Executive and internal audit.
This contact should be used as an opportunity to gain insights
into new and emerging risks and issues facing the organisation
and to discuss the role the Chief Executive expects internal
audit to fulfill in the company.
8. 2. Board of Directors:
The Head of Internal Audit may formally report to the Board of
Directors on the effectiveness of the internal audit function in
order to exchange views and ideas.
As the Audit Committee is usually a sub-committee of the Board,
this responsibility is often delegated to the Audit Committee.
As a minimum, it is important that the Head of Internal Audit has
direct access to the Chair of the Board and the Chief Executive,
as and when required.
3.Audit committee:
Audit Committees play an integral role in the governance framework
of organizations. It assists Chief Executives and Boards to
understand whether key controls are appropriate and operating
effectively
In this respect, the relationship between internal audit and the Audit
Committee is crucial and has a number of dimensions which are
mentioned below:
a. Advise the Chief Executive about the internal audit plans of the
organisation.
b. Direct or coordinate work programs relating to internal and
external audits.
c. Review the adequacy of responses to reports of internal and
external audits.
d. Utilize the internal audit function to undertake secretariat
compliance
9. e. Utilize internal audit reports and its general interaction with the
Internal Audit team, to assess the effectiveness of controls and the
performance of the organisation.
4. Senior management:
To effectively fulfill its responsibilities, it is important
that internal audit has a professional and constructive
relationship with senior management of the
organization.
Internal auditors should interact on a regular basis with
members of the senior management team, and through
the delivery of practical, business-focused and useful
reports and advice, build a relationship that is based on
cooperation, collaboration and mutual respect.
These meetings should also be used to obtain informal
feedback about the performance of internal audit and to
assist in identifying ways that internal audit can best
assist organization management.
5. External auditors:
External auditors too must help in developing internal audit
strategy and internal audit work plan.
Both audit teams need to address the key financial and business
systems underpinning the company's financial statements and to
avoid duplication of compliance and assurance.
10. To avoid such duplication, the external auditor must evaluate the
work of the internal audit function to determine its adequacy for
external audit purposes.
The Internal audit function can be made responsible for liaising
with external auditor on behalf of the organization. Such a role
can be a useful way for an internal audit team to be aware of
planned and actual external audit coverage.
Thus, a constructive relationship between both sets of auditors
assists in the conduct of external audits.
Such a role can only be fulfilled when there is healthy
communication between teams which can be achieved by
establish meetings to allow for a routine exchange of information.
6. Other reviewers:
Internal audit is one of a number of internal and external
review and assurance activities that exist as part of an
organization’s governance arrangements.
The company shall benefit when all these activities, such as
those performed by the Ombudsman and regulators, operate in
a coordinated and complementary manner to the greatest
extent possible.
This requires regular formal and informal contact between
review bodies to minimize duplication and overlap.
Some organisations see a benefit in protocols being formalised
for such activities: providing, for example, for the regular
11. exchange of views and information and for the reporting of the
results of work undertaken in a coordinated manner.
Protocols can be particularly important in situations where
internal audit needs to work closely with other entities as a
result of inter-agency or other agreements.
REFERENCES:
1. Vedanabhlata S, Gupta VN. A review on audits and
compliance management. Asian J Pharm Clin Res 2013;6:43-
5.
2. Sharma S, Kohli S, Potdar M. Current good manufacturing
practices: Audit.
3. Active Pharmaceutical Ingredients Committee (APIC).
Auditing guide; 2016. Available from:
http://apic.cefic.org/pub/Auditing/APIC_CEFIC_Auditing
guideAugust2016.pdf.
https://drpotdar.wordpress.com/2008/04/30/audit/.