Lovely Professional University, Punjab

Course Code Course Title Course Planner

MPA203T QUALITY CONTROL AND QUALITY ASSURANCE 13145::Dr. Amit Mittal

Course Outcomes :Through this course students should be able to

CO1 :: Develop understanding of quality control and quality assurance in pharmaceutical industry
CO2 :: Illustrate GLP and cGMP guidelines
CO3 :: Discuss various aspects of pharmaceutical facility inspection
CO4 :: Enumerate quality control tests for raw material, finished product and packaging material
CO5 :: Describe the importance of documentation in pharmaceutical industry
CO6 :: Use of process parameters in drug product quality

Reference Books ( R )
Sr No Title Author Publisher Name
R-1 HOW TO PRACTICE GMP’S PP SHARMA VANDANA PUBLICATIONS
R-2 QUALITY ASSURANCE AND Y.ANJANEYULU AND PHARMAMED PRESS
QUALITY MANAGEMENT IN R. MARAYYA
PHARMACEUTICAL INDUSTRY

Relevant Websites ( RW )
Sr No (Web address) (only if relevant to the course) Salient Features
RW-1 http://cpcsea.nic.in/Auth/index.aspx This weblink provides detail information about ethical guidelines for
conducting animal studies
RW-2 https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html This weblink provides detail information regarding various Q-guidelines

LTP week distribution: (LTP Weeks)

Weeks before MTE 8
Weeks After MTE 7
Spill Over (Lecture) 8

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Detailed Plan For Lectures
Week Lecture Broad Topic(Sub Topic) Chapters/Sections of Other Readings, Lecture Description
Number Number Text/reference Relevant Websites,
books Audio Visual Aids,
software and Virtual
Labs
Week 1 Lecture 1 Introduction to quality R-2 Zero Lecture
control and quality (L:1):Introductory
assurance(concept and lecture will
evolution of quality control be given regarding the
and quality assurance) course like L T P
Credits and text book of
the course, relevant
resources, course
assessment model,
objectives of course and
course contents.
L 2: Concept and
evolution of quality
control and quality
assurance
Lecture 2 Introduction to quality R-2 Zero Lecture
control and quality (L:1):Introductory
assurance(concept and lecture will
evolution of quality control be given regarding the
and quality assurance) course like L T P
Credits and text book of
the course, relevant
resources, course
assessment model,
objectives of course and
course contents.
L 2: Concept and
evolution of quality
control and quality
assurance
Lecture 3 Introduction to quality R-2 L3: Importance and
control and quality components of good
assurance(good laboratory laboratory practice
practice)
Lecture 4 Introduction to quality R-1 L 4: Concept of good
control and quality manufacturing practice
assurance(GMP) L 5: Significance of
good manufacturing
practices
An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Learning Outcomes Pedagogical Tool Live Examples
Demonstration/
Case Study /
Images /
animation / ppt
etc. Planned
L 1: Students will Discussion
learn overview of this
course and
importance of quality
control and quality
assurance
L 2: Student will
learn about the scope
of quality control and
quality assurance in
the pharmaceutical
facility
L 1: Students will Discussion
learn overview of this
course and
importance of quality
control and quality
assurance
L 2: Student will
learn about the scope
of quality control and
quality assurance in
the pharmaceutical
facility
L3: Student will learn Discussion
about the various
components of good
laboratory practices
L 4: Student will Discussion
learn about the
concept of good
manufacturing
practices
L 5: Importance and
components of GMP
Week 2 Lecture 5 Introduction to quality R-1 L 4: Concept of good L 4: Student will Discussion
control and quality manufacturing practice learn about the
assurance(GMP) L 5: Significance of concept of good
good manufacturing manufacturing
practices practices
L 5: Importance and
components of GMP
Lecture 6 Introduction to quality RW-2 L6: Introduction to ICH L6: Student will learn Discussion
control and quality guidelines about the structure of
assurance(overview of ICH L7: Brief description of ICH guideline
guidelines - QSEM, with various Q- series L7: Student will learn
special emphasis on Q-series guidelines about the concept of
guidelines) Q-series guideline
Lecture 7 Introduction to quality RW-2 L6: Introduction to ICH L6: Student will learn Discussion
control and quality guidelines about the structure of
assurance(overview of ICH L7: Brief description of ICH guideline
guidelines - QSEM, with various Q- series L7: Student will learn
special emphasis on Q-series guidelines about the concept of
guidelines) Q-series guideline
Lecture 8 Good laboratory practices R-2 L8: Scope of GLP L8: Student will learn Discussion
and cGMP guidelines(scope L9: Quality assurance about the scope of
of GLP, definitions, quality unit GLP in the
assurance unit) production facility

L9: Student will

learn about the
structure of quality
assurance unit in
production facility
Week 3 Lecture 9 Good laboratory practices R-2 L8: Scope of GLP L8: Student will learn Discussion
and cGMP guidelines(scope L9: Quality assurance about the scope of
of GLP, definitions, quality unit GLP in the
assurance unit) production facility

L9: Student will

Lecture 10 Good laboratory practices RW-1 L10: Protocol for
and cGMP guidelines conduct of non clinical
(protocol for conduct of non testing
clinical testing) L11: Protocol for
conduct of non clinical
testing
learn about the
structure of quality
assurance unit in
production facility
L10: Student will Discussion
learn about the
protocol for conduct
of non clinical testing
L11: Student will
learn about the
protocol for conduct
of non clinical testing

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 3 Lecture 11 Good laboratory practices RW-1 L10: Protocol for L10: Student will Discussion
and cGMP guidelines conduct of non clinical learn about the
(protocol for conduct of non testing protocol for conduct
clinical testing) L11: Protocol for of non clinical testing
conduct of non clinical L11: Student will
testing learn about the
protocol for conduct
of non clinical testing
Lecture 12 Good laboratory practices RW-1 L12: Control on animal L12: Student will Discussion
and cGMP guidelines house learn about the
(control on animal house) L13: control on animal description and
house control on animal
house
L13: Student will
learn about the
description and
control on animal
house
Week 4 Lecture 13 Good laboratory practices RW-1 L12: Control on animal L12: Student will Discussion
and cGMP guidelines house learn about the
(control on animal house) L13: control on animal description and
house control on animal
house
L13: Student will
learn about the
description and
control on animal
house
Lecture 14 Good laboratory practices R-1 L14: Report preparation L14: Student will Discussion
and cGMP guidelines(report and documentation learn about the
preparation and L15: Report preparation importance of
documentation) and documentation documentation and
structure of report
L15: Student will
learn about the
importance of
documentation and
structure of report
Lecture 15 Good laboratory practices R-1 L14: Report preparation L14: Student will Discussion
and cGMP guidelines(report and documentation learn about the
preparation and L15: Report preparation importance of
documentation) and documentation documentation and
structure of report
L15: Student will
learn about the
importance of
documentation and
structure of report

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 4 Lecture 16 Good laboratory practices R-1 L16: Introduction to L16: Student will Discussion
and cGMP guidelines(cGMP cGMP guidelines learn about the cGMP
guidelines according to L17: Brief description of guidelines
schedule M, USFDA schedule M L17: Student will
(inclusive of CDER and L18: Introduction to learn about the
CBER)) USFDA (inclusive of schedule M
CDER and CBER) L18: Student will
learn about the
regulations of
USFDA
Week 5 Lecture 17 Good laboratory practices R-1 L16: Introduction to L16: Student will Discussion
and cGMP guidelines(cGMP cGMP guidelines learn about the cGMP
guidelines according to L17: Brief description of guidelines
schedule M, USFDA schedule M L17: Student will
(inclusive of CDER and L18: Introduction to learn about the
CBER)) USFDA (inclusive of schedule M
CDER and CBER) L18: Student will
learn about the
regulations of
USFDA
Lecture 18 Good laboratory practices R-1 L16: Introduction to L16: Student will Discussion
and cGMP guidelines(cGMP cGMP guidelines learn about the cGMP
guidelines according to L17: Brief description of guidelines
schedule M, USFDA schedule M L17: Student will
(inclusive of CDER and L18: Introduction to learn about the
CBER)) USFDA (inclusive of schedule M
CDER and CBER) L18: Student will
learn about the
regulations of
USFDA
Lecture 19 Pharmaceutical inspection R-1 L19: Organization and L19: Student will Discussion
convention, WHO and personnel learn about the
EMEA(organization and responsibilities structure of
personnel responsibilities, L20: Training, hygiene organization and
training, hygiene and and personal records various
personal records) responsibilities
L20: Student will
learn about the
various types of
training and
importance of
personal records

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 5 Lecture 20 Pharmaceutical inspection R-1 L19: Organization and L19: Student will Discussion
convention, WHO and personnel learn about the
EMEA(organization and responsibilities structure of
personnel responsibilities, L20: Training, hygiene organization and
training, hygiene and and personal records various
personal records) responsibilities
L20: Student will
learn about the
various types of
training and
importance of
personal records
Week 6 Lecture 21 Pharmaceutical inspection R-1 L21: Drug industry L21: Student will Discussion
convention, WHO and location, design learn about the
EMEA(drug L22: Construction and concept of industry
industry location, design, plant lay out location
construction and plant lay L22: Student will
out) learn about the
concept of design and
plant layout
Lecture 22 Pharmaceutical inspection R-1 L21: Drug industry L21: Student will Discussion
convention, WHO and location, design learn about the
EMEA(drug L22: Construction and concept of industry
industry location, design, plant lay out location
construction and plant lay L22: Student will
out) learn about the
concept of design and
plant layout
Lecture 23 Pharmaceutical inspection R-1 L 23: Maintenance, L 23: Student will Discussion
convention, WHO and sanitation learn about the
EMEA(maintenance, L 24: Environmental maintenance and
sanitation, environmental control sanitation in
control) production facility
L 24: Student will
learn about the
importance of
environmental
control
Lecture 24 Pharmaceutical inspection R-1 L 23: Maintenance, L 23: Student will Discussion
convention, WHO and sanitation learn about the
EMEA(maintenance, L 24: Environmental maintenance and
sanitation, environmental control sanitation in
control) production facility
L 24: Student will
learn about the
importance of
environmental
control

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 7 Lecture 25 Pharmaceutical inspection R-1 L 25: Utilities and L 25: Student will Discussion
convention, WHO and maintenance of sterile learn about the
EMEA(utilities and areas procedure of
maintenance of sterile areas, L 26: Control of maintenance of
control of contamination) contamination sterile areas
L 26: Preventive
measures to control
the contamination
Lecture 26 Pharmaceutical inspection R-1 L 25: Utilities and L 25: Student will Discussion
convention, WHO and maintenance of sterile learn about the
EMEA(utilities and areas procedure of
maintenance of sterile areas, L 26: Control of maintenance of
control of contamination) contamination sterile areas
L 26: Preventive
measures to control
the contamination
Lecture 27 Pharmaceutical inspection R-1 L 27: Concept of good L 27: Student will be Discussion
convention, WHO and warehousing practice understood about the
EMEA(good warehousing L 28: Good warehousing structure of
practice) practice importance warehouse
L 28: Student will
learn about the
importance of good
warehousing
practices
Lecture 28 Pharmaceutical inspection R-1 L 27: Concept of good L 27: Student will be Discussion
convention, WHO and warehousing practice understood about the
EMEA(good warehousing L 28: Good warehousing structure of
practice) practice importance warehouse
L 28: Student will
learn about the
importance of good
warehousing
practices
Week 8 Lecture 29 Pharmaceutical inspection RW-1 L 29: Introduction to L 29: Introduction to Discussion
convention, WHO and CPCSEA guidelines CPCSEA guidelines
EMEA(CPCSEA guidelines) L 30: CPCSEA L 30: Student will
guidelines regulations understand various
regulations under
CPCSEA guidelines
Lecture 30 Pharmaceutical inspection RW-1 L 29: Introduction to L 29: Introduction to Discussion
convention, WHO and CPCSEA guidelines CPCSEA guidelines
EMEA(CPCSEA guidelines) L 30: CPCSEA L 30: Student will
guidelines regulations understand various
regulations under
CPCSEA guidelines

SPILL OVER
Week 8 Lecture 31 Spill Over

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 8 Lecture 32 Spill Over

MID-TERM
Week 9 Lecture 33 In process, finished product R-2 L 33: Analysis of raw Student will learn Discussion
and packaging material materials, finished various tools for
quality controls(analysis of products, packaging anlaysis of raw
raw materials, finished materials materials, finished as
products, packaging well as packaging
materials) materials
Lecture 34 In process, finished product R-1 L 34: In process quality Student will Discussion
and packaging material control (IPQC) understand various in
quality controls(in process process quality
quality control (IPQC)) control tests
Lecture 35 In process, finished product RW-2 L 35: Developing Student will learn Discussion
and packaging material specification (ICH Q6 about the detail
quality controls(developing and Q3) specification of ICH
specification (ICH Q6 and Q6 and Q3
Q3))
Lecture 36 In process, finished product R-1 L 36: Purchase Student will learn Discussion
and packaging material specifications and about the
quality controls(purchase maintenance of stores maintenance of raw
specifications and for raw materials material as per GMP
maintenance of stores for
raw materials)
Week 10 Lecture 37 In process, finished product R-1 L 37: In process quality Student will Discussion
and packaging material control and finished understand various
quality controls(in process products quality control IPQC tests for tablets
quality control and finished for following and capsules
products quality control for formulation in Pharma
following formulation in industry according to
Pharma industry according Indian, US and British
to Indian, US and British pharmacopoeias: tablets,
pharmacopoeias:tablets, capsules
capsules)
Lecture 38 In process, finished product R-2 L 38: ointments, Student will leran Discussion
and packaging material suppositories, creams about the IPQC tests
quality controls(ointments, of ointments,
suppositories, creams) suppositries and
creams
Lecture 39 In process, finished product R-1 L 39: Parenterals, Student will learn Discussion
and packaging material ophthalmic and surgical about the IPQC tests
quality controls(parenterals, products (how to refer for parenterals,
ophthalmic and surgical pharmacopoeias) ophthalmic and
products (how to refer surgical products
pharmacopoeias))

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 10 Lecture 40 In process, finished product R-1 L 40: Quality control Student will learn Discussion
and packaging material test for containers, about the various QC
quality controls(quality closures and secondary tests for packaging
control test for containers, packing materials materials
closures and secondary
packing materials)
Week 11 Lecture 41 Documentation in R-1 L 41: Three tier Student will learn Discussion
pharmaceutical industry documentation about the concept of
(three tier documentation) three tier
documentation
Lecture 42 Documentation in R-2 L 42: Policy, procedures Student will learn Discussion
pharmaceutical industry and work instructions, about the various
(policy, procedures and and records (Formats) formats and
work instructions, and basic principles- how to maintenance of
records (Formats)) maintain, retention and records
retrieval etc.

Documentation in R-2 L 42: Policy, procedures Student will learn Discussion

pharmaceutical industry and work instructions, about the various
(basic principles- how to and records (Formats) formats and
maintain, retention and basic principles- how to maintenance of
retrieval etc.) maintain, retention and records
retrieval etc.

Lecture 43 Documentation in R-1 L 43: Standard operating Student will learn Discussion
pharmaceutical industry procedures (how to how to write SOP
(standard operating write)
procedures (how to write))
Lecture 44 Documentation in R-1 L 44: Master formula Student will learn Discussion
pharmaceutical industry record about the
(master formula record) development of
master formula
Documentation in R-1 L 44: Batch formula Student will learn Discussion
pharmaceutical industry record about the
(batch formula record) development of batch
formula
Week 12 Lecture 45 Documentation in R-1 L 45: Quality audit plan Student will learn Discussion
pharmaceutical industry and reports about importance of
(quality audit plan and audit and reports
reports)
Lecture 46 Documentation in R-1 L 46: Specification and Student will learn Discussion
pharmaceutical industry test procedures about development of
(specification and test test procedures
procedures)
Lecture 47 Documentation in R-1 L 47: Protocols and Student will learn Discussion
pharmaceutical industry reports about the preparation
(protocols and reports) of reports and
protocols

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 12 Lecture 48 Documentation in R-1 L 48: Distribution Student will learn Discussion
pharmaceutical industry records about the importance
(distribution records) of records
Documentation in R-1 L 48: Electronic data Student will learn Discussion
pharmaceutical industry about the importance
(electronic data) of electronic data
Week 13 Lecture 49 Manufacturing operations R-1 L 49: Sanitation of Student will learn Discussion
and controls(sanitation of manufacturing premises about the importance
manufacturing premises) of sanitation in
production
Manufacturing operations R-1 L 49: Mix-ups and cross Student will learn Discussion
and controls(mix-ups and contamination about the impact of
cross contamination) cross contamination
Lecture 50 Manufacturing operations R-1 L 50: processing of Student will learn Discussion
and controls(processing of intermediates and bulk about the process
intermediates and bulk products parameters
products)
Manufacturing operations R-1 L 50: Packaging Student will learn Discussion
and controls(packaging operations about the packaging
operations) operations
Lecture 51 Manufacturing operations R-1 L 51: IPQC Student will learn Discussion
and controls(IPQC) about various IPQC
tests
Manufacturing operations R-1 L 51: Release of Student will learn Discussion
and controls(release of finished product about criteria for
finished product) finished products
Lecture 52 Manufacturing operations R-1 L 52: Process deviations Student will Discussion
and controls(process understand about the
deviations) significance of
process deviations
Manufacturing operations R-1 L 52: Charge-in of Student will Discussion
and controls(charge-in of components understand about the
components) significance of
charge-in of
components
Week 14 Lecture 53 Manufacturing operations R-1 L 53: Time limitations Student will learn Discussion
and controls(time limitations on production about the importance
on production) of time limitations in
production
Manufacturing operations R-1 L 53: Drug product Student will learn Discussion
and controls(drug product inspection about the procedure
inspection) for drug product
inspection
Lecture 54 Manufacturing operations R-1 L 54: Expiry date Student will learn Discussion
and controls(expiry date calculation about the method for
calculation) expiry date
calculation

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.
Week 14 Lecture 54 Manufacturing operations R-1 L 54: Calculation of Student will learn Discussion
and controls(calculation of yields about the method for
yields) calculation of yields
Lecture 55 Manufacturing operations R-1 L 55: Production record Student will Discussion
and controls(production review understand the
record review) review of production
record and its impact
in pharmaceutical
industry
Manufacturing operations R-1 L 55: Change control Student will Discussion
and controls(change control) understand the
change control
Lecture 56 Manufacturing operations R-1 L 56: Sterile products Student will learn Discussion
and controls(sterile about the various
products) sterile products
Week 15 Lecture 57 Manufacturing operations R-1 L 57: Aseptic process Student will learn Discussion
and controls(aseptic process control about the aseptic
control) process control and
its importance in
sterile manufacturing
Lecture 58 Manufacturing operations R-1 L 58: Packaging Student will Discussion
and controls(packaging) understand the
specification and
importance of
packaging materials

SPILL OVER
Week 15 Lecture 59 Spill Over
Lecture 60 Spill Over
Week 16 Lecture 61 Spill Over
Lecture 62 Spill Over
Lecture 63 Spill Over
Lecture 64 Spill Over

An instruction plan is only a tentative plan. The teacher may make some changes in his/her teaching plan. The students are advised to use syllabus for preparation of all examinations. The students are expected to keep themselves
updated on the contemporary issues related to the course. Upto 20% of the questions in any examination/Academic tasks can be asked from such issues even if not explicitly mentioned in the instruction plan.