documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
DOCUMENTATION IN PHARMACEUTICAL INDUSTRY :
WORKING INSTRUCTIONS AND RECORD FORMATS
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
To ensure that authorized persons have all the information necessary to decide whether or not realize a batch of drug for sale.
To ensure the existence of documented evidence , trace ability and adult trail that will permit investigation.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
DOCUMENTATION IN PHARMACEUTICAL INDUSTRY :
WORKING INSTRUCTIONS AND RECORD FORMATS
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
To ensure that authorized persons have all the information necessary to decide whether or not realize a batch of drug for sale.
To ensure the existence of documented evidence , trace ability and adult trail that will permit investigation.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
Documentation in pharmaceutical industryPooja Harkal
It's all about the topic of documentation in pharmaceutical industry. In this the specifications of pharmaceutical quality assurance plays the main role so that it's mainly effective for the people who is in the stream of pharmaceutical quality assurance.
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Documentation in pharmaceutical industryPooja Harkal
It's all about the topic of documentation in pharmaceutical industry. In this the specifications of pharmaceutical quality assurance plays the main role so that it's mainly effective for the people who is in the stream of pharmaceutical quality assurance.
Documentation control - principles of GMPAJAYKUMAR4872
Documentation is an essential part of QA and relates to all aspects of GMP.
The pharmaceutical industry must have a good document framework (infrastructure).
It is important for a manufacturer to get the documentation right in order to get the product right.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
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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.
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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
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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
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
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!
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
MATATAG CURRICULUM: ASSESSING THE READINESS OF ELEM. PUBLIC SCHOOL TEACHERS I...NelTorrente
In this research, it concludes that while the readiness of teachers in Caloocan City to implement the MATATAG Curriculum is generally positive, targeted efforts in professional development, resource distribution, support networks, and comprehensive preparation can address the existing gaps and ensure successful curriculum implementation.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
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Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
2. Batch Manufacturing Record (BMR)
As a part of international regulatory standards of Good Manufacturing Practice (GMP),
pharmaceutical industries are required to maintain documentation of the entire
manufacturing process and batch execution process.
A batch manufacturing record is a document designed to provide a complete record of the
manufacturing history of a batch of product.
The terminology is widely applied within the Pharmaceutical & Chemical industries and is
referenced in many of the pharmaceutical and food regulatory agency requirements.
The US Food and Drug Administration (FDA) defines a batch as “a specific quantity of a drug
or other material that is intended to have uniform character and quality, within specified
limits, and is produced according to a single manufacturing order during the same cycle of
manufacture”.
3. Batch Manufacturing Record (BMR)
Batch Manufacturing Records are critical documents for ensuring quality and regulatory
requirements are achieved.
They normally contain information that relates to the following aspects of the manufacture of a
batch of product:
• Dates of start and finish of manufacture
• Lists all materials used and amounts of each used
• Lists of packaging materials used
• Details of the steps completed in the manufacturing process and times of completion
• Initials of the person responsible at every stage
• Details and results of all in-process checks
• Reference to any equipment used
• Batch yield and reconciliation
• Any deviations
• Quality control information
4. Batch Manufacturing Record (BMR)
In many cases, the Batch Manufacturing Records are written in an instructional format with areas
for the operator to enter processing information.
It is very important to provide the information in the Batch Manufacturing Record where requested.
For certain critical operations, e.g., weighing of raw materials, a second person must check
calculations and identity of materials and sign off on the Batch Manufacturing Record.
Each batch has an individual number, written on the Batch Manufacturing Record.
Batch Manufacturing Record must be:
• Legible
• Permanent
• Accurate
• Original
• Signed
All corrections and deviations must be recorded and signed off in the Batch Manufacturing Record.
5. Batch Manufacturing Record (BMR)
The following are the specific information to be detailed within a Batch Manufacturing
Record as defined by the US FDA, under the CFR (Code of Federal Regulations) Title 21, Sec.
111.260.
“What must the batch record include?”
The batch production record must include the following:
a) The batch, lot, or control number:
1) Of the finished batch of dietary supplement; and
2) That you assign in accordance with 111.415 (f) for the following:
i. Each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement;
ii. Each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to
another person for packaging or labeling;
b) The identity of equipment and processing lines used in producing the batch;
6. Batch Manufacturing Record (BMR)
c) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing
lines used in producing the batch, or a cross-reference to records, such as individual equipment
logs, where this information is retained;
d) The unique identifier that you assigned to each component (or, when applicable, to a product that
you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label
used;
e) The identity and weight or measure of each component used;
f) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate
phases of processing;
g) The actual results obtained during any monitoring operation;
h) The results of any testing or examination performed during the batch production, or a cross-
reference to such results;
i) Documentation that the finished dietary supplement meets specifications established in accordance
with 111.70 (e) and (g);
7. Batch Manufacturing Record (BMR)
j) Documentation, at the time of performance, of the manufacture of the batch, including:
1) The date on which each step of the master manufacturing record was performed; and
2) The initials of the persons performing each step, including:
i. The initials of the person responsible for weighing or measuring each component used in the batch;
ii. The initials of the person responsible for verifying the weight or measure of each component used in
the batch;
iii. The initials of the person responsible for adding the component to the batch; and
iv. he initials of the person responsible for verifying the addition of components to the batch;
k) Documentation, at the time of performance, of packaging and labeling operations, including:
1) The unique identifier that you assigned to packaging and labels used, the quantity of the
packaging and labels used, and, when label reconciliation is required, reconciliation of any
discrepancies between issuance and use of labels;
8. Batch Manufacturing Record (BMR)
2) An actual or representative label, or a cross-reference to the physical location of the actual or
representative label specified in the master manufacturing record; and
3) The results of any tests or examinations conducted on packaged and labeled dietary
supplements (including repackaged or relabeled dietary supplements), or a cross-reference to
the physical location of such results;
l) Documentation at the time of performance that quality control personnel:
1) Reviewed the batch production record, including:
i. Review of any monitoring operation required under subpart E of this part; and
ii. Review of the results of any tests and examinations, including tests and examinations conducted
on components, in-process materials, finished batches of dietary supplements, and packaged
and labeled dietary supplements;
9. Batch Manufacturing Record (BMR)
2) Approved or rejected any reprocessing or repackaging; and
3) Approved and released, or rejected, the batch for distribution, including any reprocessed batch;
and
4) Approved and released, or rejected, the packaged and labeled dietary supplement, including
any repackaged or relabeled dietary supplement.
m) Documentation at the time of performance of any required material review and disposition
decision.
n) Documentation at the time of performance of any reprocessing.
10. Importance of Production Management
The importance of production management in a business is that it will spearhead the
process which will ultimately bring in profit to the business.
There are several responsibilities and tasks that a production management team is
responsible for and it is a very stressful job.
It is also stated that it is very important for the management to form good relations with the
various teams within the organization as well.
11. Importance of Production Management
The importance of production management to the business firm:
1. Accomplishment of firm's objectives: Production management helps the business firm
to achieve all its objectives. It produces products, which satisfy the customers' needs
and wants. So, the firm will increase its sales. This will help it to achieve its objectives.
2. Reputation, Goodwill and Image: Production management helps the firm to satisfy its
customers. This increases the firm’s reputation, goodwill and image. A good image helps
the firm to expand and grow.
3. Helps to introduce new products: Production management helps to introduce new
products in the market. It conducts Research and development (R&D). This helps the
firm to develop newer and better-quality products. These products are successful in the
market because they give full satisfaction to the customers.
12. Importance of Production Management
4. Supports other functional areas: Production management supports other functional
areas in an organization, such as marketing, finance, and personnel. The marketing
department will find it easier to sell good-quality products, and the finance department
will get more funds due to increase in sales. It will also get more loans and share capital
for expansion and modernization. The personnel department will be able to manage the
human resources effectively due to the better performance of the production
department.
5. Helps to face competition: Production management helps the firm to face competition
in the market. This is because production management produces products of right
quantity, right quality, right price and at the right time. These products are delivered to
the customers as per their requirements.
13. Importance of Production Management
6. Optimum utilization of resources: Production management facilitates optimum
utilization of resources such as manpower, machines, etc. So, the firm can meet its
capacity utilization objective. This will bring higher returns to the organization.
7. Minimizes cost of production: Production management helps to minimize the cost of
production. It tries to maximize the output and minimize the inputs. This helps the firm
to achieve its cost reduction and efficiency objective.
8. Expansion of the firm: The Production management helps the firm to expand and grow.
This is because it tries to improve quality and reduce costs. This helps the firm to earn
higher profits. These profits help the firm to expand and grow.
14. Importance of Production Management
The importance of production management to customers and society:
1. Higher standard of living: Production management conducts continuous research and
development (R&D). So, they produce new and better varieties of products. People use
these products and enjoy a higher standard of living.
2. Generates employment: Production activities create many different job opportunities in
the country, either directly or indirectly. Direct employment is generated in the
production area, and indirect employment is generated in the supporting areas such as
marketing, finance, customer support, etc.
3. Improves quality and reduces cost: Production management improves the quality of
the products because of research and development. Because of large-scale production,
there are economies of large scale. This brings down the cost of production. So,
consumer prices also reduce.
15. Importance of Production Management
4. Spread effect: Because of production, other sectors also expand. Companies making
spare parts will expand. The service sector such as banking, transport, communication,
insurance, BPO, etc. also expand. This spread effect offers more job opportunities and
boosts economy.
5. Creates utility: Production creates form utility. Consumers can get form utility in the
shape, size and designs of the product. Production also creates time utility, because
goods are available whenever consumers need it.
6. Boosts economy: Production management ensures optimum utilization of resources
and effective production of goods and services. This leads to speedy economic growth
and well-being of the nation.
16. Production Management Software Solutions
While the concept of systemized production management is not new, with the arrival of the
digital age companies have tools available to them that were not possible before.
Production management software can take the system described above to the next level,
further homing in to improve all areas through the identification of deeper levels of data
that can be turned into improvements.
It also automates many functions reducing both time and human error.
Here are some of the benefits that production management software can deliver:
• Cloud-Based
• Intuitive and User Friendly
• Analytics
• Interoperability
• Customizable
17. Production Management Software Solutions
Cloud-Based: Most available software solutions today are cloud-based. This means that
manufacturers using these platforms do not need to have a heavy infrastructure or IT
presence to deploy.
This is especially important for small and medium-sized businesses (SMB) who may not
have in-house skillsets for IT and may not be able to afford a traditional enterprise-level
system.
It also means that companies always have access to the most updated version of the
software, eliminating the need for costly and time-consuming periodic upgrades.
18. Production Management Software Solutions
Intuitive and User Friendly: Software is also more user friendly using intuitive dashboards,
drop-downs, and drag-and-drop features to simplify tasks.
This may be in the form of drag-and-drop scheduling or perhaps in the automation of the
purchasing process.
In cases like these, rules-based logic can automate these and other tasks to eliminate the
need for manual monitoring.
And because the data being analyzed is real-time, it means that these functional areas are
optimized.
Finally, intuitive and user-friendly platforms reduce training time and the cost associated
with steep learning curves.
19. Production Management Software Solutions
Analytics: Today’s production management software uses deep analytics to automate and
produce more accurate views of the workflow and of the entire production operation.
This includes shop floor reporting, workforce, and labor utilization, equipment loading, and
more.
It aligns Bills of Material (BOM) with manufacturing routing and uses real-time production
performance data to maintain adherence to standards and to allow managers to make
decisions in real-time with accurate data.
20. Production Management Software Solutions
Interoperability: One traditional barrier to better production management was the
existence of siloed data.
With each respective department and support area maintaining their own system and
software for managing data, information was not real-time and had to be reconciled before
it could be acted upon at higher levels.
Today, production management software can integrate through APIs with other third-party
applications.
This allows it to become part of an end-to-end ecosystem for managing business practices.
Its real-time flow and integration of data from production can be tied to finance systems,
billing systems, quality management, and others to offer seamless integration and a more
holistic visualization of manufacturing and its total imp
21. Production Management Software Solutions
Customizable: Agility and flexibility are important in today’s hyper-competitive markets.
And production management software is customizable to allow companies to leverage
flexibility to only use the functionality they need.
This allows manufacturers to only use the needed functionality, reducing clutter in the user
experience, and improving efficiency.
It can be utilized specifically for production but is flexible and agile to incorporate modules
for CRM, inventory control, supply chain management, and procurement.
This is highly valuable for SMBs whose staff often performs tasks and duties across several
departments or functional areas and who need a comprehensive production management
system tied to a larger suite of functions.
22. Production Management Software Solutions
For manufacturing, production management is the systemized deployment of techniques
and methods that allow managers to control production and deliver the lowest cost, highest
quality finished goods in pursuit of business objectives.
It can be implemented in any size factory and enhanced through the use of production
management software.