This presentation introduces pharmaceutical quality assurance and quality control. It discusses that quality assurance covers all aspects of production from raw materials to finished products. Quality control ensures drugs are safe, effective and consistent. The presentation covers in-process quality control, production processes like blending and milling, and quality control of the storage facility. It also discusses technology transfer requirements for pharmaceutical production like manufacturing instructions, analytical methods and batch records.

2. Welcome
To
our
PresenTaTion

3. Presented To
simin shabnam loPa
b. Pharm & m. Pharm (r.u.)
lacTurer DeParTmenT of
Pharmacy,VarenDra uniVersiTy

4. Presented By
Group:
Revenue

5. Group Members
Saima Akter
ID No.: 151211046
Md. Jebon Mia
ID No.: 151211050

6. Sadi Md. Jubaeer
ID No: 151211047
Priyanka Rani
ID No : 151211038
Most.Khadija Akter Riva
ID No: 151211051

7. Md. Ifta Khairul Islam
ID No: 151211058
Al Asma Hawa
ID No: 151211066

8. A Pharmaceutical
Industry
Presentation
On

10. What is Quality
• The ability to make the same thing the same way,
over and over again
• Customer buys today is same as what they bought
last week or will buy next week
• Product meets customer’s expectations 100% of
the time

11. Quality Assurance
• Covers everything from raw materials and GMP
verification through finished-product release
• HACCP is part of QA
• Quality Control
• Actual manufacturing process

12. Quality Assurance Operation
• Reviewing the daily lab and production reports is a
part of the QA responsibilities. This is to determine
that the procedures are being followed and the tests
are being made. QA can spot trends by conducting
consistent record reviews. If record reviews don’t
stay current, no one will get timely feedback before
a real problem crops up.

13. The Pharmaceutical Quality Assurance & Quality
Control program combines theoretical knowledge
with hands-on skills in all areas that impact drug
quality.

14. Cont……

15. Quality control
• Quality control is an essential operation of the
pharmaceutical industry. Drugs must be marketed
as safe and therapeutically active formulations
whose performance is consistent and predictable..

16. Quality control

17. IPC
• In-process methods are key components of quality
control in a chemical manufacturing plant. These
methods ensure that a production reaction step
conducted by trained operators It ensures the best
API.

18. Production
• Production involves the propagation, conversion, or
processing of a drug or device, either directly or
indirectly, by extraction of the drug from
substances of natural origin or by means of
chemical or biological synthesis.
Production also includes
• 1.Any packaging or repackaging of the
substance(s) or labeling or relabeling of containers
for the promotion and marketing of such drugs or
devices.

19. Production
2.Any preparation of a drug or device that is given or
sold for resale by pharmaciest , practitioners, or other
persons.
3.The distribution of inordinate amounts of
compounded preparations or the copying of
commercially available drug products.
4.The preparation of any quantity of a drug product
without a licensed prescriber/patient/licensed
pharmacist/compounder relationship.

20. Unit Operations of Production
1.Formulation and Pre-Formulation Development:
Before a drug can be Produced at any scale, much work
goes into the actual formulation of the drug. Formulation
development scientists must evaluate a compound for
uniformity, stability and many other factors. After the
evaluation phase, a solution must be developed to deliver the
drug in its required form such as solid, semi-solid, immediate
or controlled release, tablet, capsule, and many other
Variations
2.Powder Blending
In the pharmaceutical industry, a wide range of excipients
may be blended together to create the final blend used to
manufacture the solid dosage form.

21. Unit Operations of Production
3.Milling
During the drug Producing process, milling is often
required in order to reduce the average particle size
in a drug powder.
4.Granulation
Granulation can be thought of as the opposite of milling; it
is the process by which small particles are bound together to
form larger particles, called granules. Granulation is used for
several reasons.

22. Production

23. Research and Development Sector in
Pharmaceutical Industry
• During the discovery research phase of development
of a medicine pharmacists will work with other
scientists to develop and select drug compounds that
may be valuable as medicines. They will also help the
project team, which might include medicinal
chemists,bioscientists,toxicologists,pharmacokinetici
sts and others, to understand the biopharmaceutical
properties of the compound, the dosage form and
how the route of administration might affect the rate
and extent of absorption. In this area a post-graduate
qualification is a particular asset.

24. Role of Research and Development Sector
in Pharmaceutical Industry
• New Product Research
• New Product development
• Existing Product Updates
• Quality Checking
• Innovation
• Formulation and packaging development
• Clinical research

25. R&D Status in Pharmaceutical Sector
Modern Medicine :
• It is mandatory to all the local and foreign
companies to follow good manufacturing practices
(GMP) as per WHO recommended guide line
• Although, top and medium level companies
strictly follow GMP and possess all high-tech
facilities in their premises, but they do not have
R&D facilities in real sense
• The top 30 local companies have well-equipped
product development (PD) department instead of
full-fledged R&D

26. R&D Status in Pharmaceutical Sector
• Recently some top pharmaceutical industries are
producing high-tech biopharmaceutical products
have started real R&D activities in a limited scale
• Only few of the APIs producers have full-fledge
R&D facilities. Most of them are manufacturing
under technology transfer from India and China

27. Storage House/ Warehouse
The storing of pharmaceutical products and materials up to
their point of use is called the storage house of a
pharmaceutical
Storage areas
1. Precautions must be taken to prevent unauthorized persons
from entering storage areas.
2. Storage areas should be of sufficient capacity to allow the
orderly storage of the various categories of materials and
products, namely starting and packaging materials,
intermediates, bulk and finished products, products in
quarantine, and released, rejected, returned or recalled
products.

28. Monitoring of storage conditions
1.Recorded temperature monitoring data should be available
for review. The equipment used for monitoring should be
checked at suitable predetermined intervals and the results of
such checks should be recorded and retained. All monitoring
records should be kept for at least the shelf-life of the stored
material or product plus 1 year, or as required by national
legislation. Temperature mapping should show uniformity of
the temperature across the storage facility. It is recommended
that temperature monitors be located in areas that are most
likely to show fluctuations.
2.Equipment used for monitoring should also be calibrated at
defined intervals.

29. Storage requirements
• Written instructions and records should be available
which document all activities in the storage areas
including the handling of expired stock. These should
adequately describe the storage procedures and define
the route of materials and pharmaceutical products and
information through the organization in the event of a
product recall being required

30. Pharmaceutical Technical Services
Pharmaceutical Technical Services (PTS) is a
focused consulting organization, specializing in
serving the GMP production and facilities'
operations activities of the pharmaceutical,
biopharmaceutical, diagnostic, and related
regulated industries

31. Pharmaceutical Technical Services
• The pharmaceutical industry discovers, develops,
produces, and markets drugs or pharmaceuticals for
use as medications. Pharmaceutical companies may
deal in generic or brand medications and medical
devices. They are subject to a variety of laws and
regulations that govern the patenting, testing, safety,
efficacy and marketing of drugs.

32. Technology transfer checklist
• It consists of…
• .Production master formula
• .Manufacturing instruction
• .Analytical methods
• .Previous process validation
• .Previous analytical validation
• .Cleaning instruction and previous cleaning validation
• .Stability reports
• .Packaging instruction
• .Specimen manufacturing batch record

33. Master Formula
• Master Formula is a full spectrum, multinutrient
complex, providing premium vitamins, minerals,
and food-based nutriment to support general
health and well-being. By utilizing a Synergistic
Suspension Isolation process – SSI Technology –
ingredients are delivered in three distinct delivery
forms. Collectively, these ingredients provide a
premium, synergistic complex to support your
body.

34. Analytical Method
• Analytical Methods welcomes early applied
demonstrations of new analytical methods with
clear societal impact. Developments are encouraged
within the fields of healthcare, pharmaceuticals and
biomedical diagnostics, environmental and forensic
analysis, heritage science, agricultural science and
food products, industrial process development and
product validation

36. Concept of Supply Chain Management
• Supply chain is a network of facilities &
distribution options that performs the function of
procurement of raw materials, transformation of
these materials into intermediate & finished
products and distribution of these products to the
customers.
• Simply stated
• The supply chain encompasses all of those
activities associated with moving goods from the
raw-materials stage through to the end user.

37. Product
Time
Price &
Profit
Place
Right
Objectives of SCMObjectives of SCM
•Objectives:-
–Right Product
–Right Place
–Right Time
–Right Price &
Profit for
the retailer

38. RAW MATERIALRAW MATERIAL
WAREHOUSEWAREHOUSE
STOCKSTOCK
MANUFACTUREMANUFACTURE
RR
WAREHOUSEWAREHOUSE
DISTRIBUTIONDISTRIBUTION
CENTRE
RETAILERETAILE
RR
CUSTOMERCUSTOMER
Flow of GoodsFlow of Goods
Flow of InformationFlow of Information
SCM also Involves
SUPPLIERSUPPLIER

39. Role of SCM
Proper implementation of SCM helps to use the
following strategic areas to their full advantage:
•1.Fulfillment:
a. Ensure the right quantity at the right time.
b. It makes sure that the right quantities are ordered.
•2.Logistics:
a. Keep the cost of transporting materials as low as
possible consistent with safe and reliable delivery.
b. Constant contact with its distribution team.

40. Role of SCM
• 3. Production:
Ensure production lines function smoothly.
• 4.Reduced Cost of
a. Inventory carrying cost
b. Internal and external failure cost
c. Purchase cost
• 5. Revenue & Profit
No Sales are lost and flexible to respond
unforeseen changes

41. Supply Chain LevelsSupply Chain LevelsSupply Chain LevelsSupply Chain Levels
• Supply Chain Design
• Resource Acquisition
• Long Term Planning (1 Year ++)
StrategicStrategic
• Production/ Distribution Planning
• Resource Allocation
• Medium Term Planning (Qtrly,Monthly)
TacticalTactical
• Production Scheduling
• Resource Scheduling
• Performance tracking
• Short Term Planning (Weekly,Daily)
OperationalOperational

42. Seven Principle of SCM
• 1. Segment customers based on service needs.
• 2. Customize the logistics network.
• 3. Listen to signals of market demand and plan
accordingly.
• 4. Differentiate product closer to the customer.
• 5. Source strategically.
• 6. Develop a supply chain-wide technology
strategy.
• 7. Adopt channel-spanning performance measures

43. Information Technology Sector
• The Information Technology Sector is central to the
nation's security, economy, and public health and
safety as businesses, governments, academia, and
private citizens are increasingly dependent upon
Information Technology Sector functions. These
virtual and distributed functions produce and
provide hardware, software, and information
technology systems and services, and in
collaboration with the Communications Sector—
the Internet

44. Operation of IT Sector
• Information Technology Sector functions are
operated by a combination of entities—often
owners and operators and their respective
associations—that maintain and reconstitute the
network, including the Internet. Although
information technology infrastructure has a certain
level of inherent resilience, its interdependent and
interconnected structure presents challenges as well
as opportunities for coordinating public and private
sector preparedness and protection activities.

46. Role of Pharmacist in a Pharmaceutical
Industry
• Research and development
Pharmacists contribute to research, and their expertise
in formulation development is of particular relevance to
the biological availability of active ingredients.
• Manufacture and quality assurance
The pharmacist’s broad knowledge of the
pharmaceutical sciences ensures an integrated approach
to quality assurance (including good manufacturing
practice) through the validation of the various stages of
production and the testing of products before release

47. Role of Pharmacist in a Pharmaceutical
Industry
• Drug information
The pharmacist has the knowledge and expertise to
provide detailed information on medicines to
members of the health professions and the public.
Also, pharmacists provide an information service
within the company.
• Patent applications and drug registration
The pharmacist is ideally qualified to understand
and collate the diverse information required for
patent and authorization submissions.

48. Role of Pharmacist in a Pharmaceutical
Industry
• Clinical trials and post-marketing surveillance
The pharmacist has the knowledge of drugs and
health care provision required to facilitate
collaboration between companies, health
professionals and governments in relation to
clinical trials and surveillance.
• Sales and marketing
The pharmacist, whose professional ethics demand
a concern for the interest of patients, can make a
contribution to proper marketing practices related
to health care and to the provision of appropriate
information to health professionals and the public.

49. Thank You