SHRI RAM INSTITUTE OF PHARMACY JABALPUR

IV/IV B.PHARMACY 7TH SEMESTER (150 HOURS)

GUIDELINES FOR PRACTICE SCHOOL MODULE

Objective
The objectives of practice school are to:
Enable students to acquire learning by applying the knowledge and skills they
possess, in unfamiliar, open-ended real life situations and also the practice
school will provide excellent in skill to put in the students main core.

Why
The program would be a simulation of real work environment and requires
students to undergo the rigor of professional setting, both in form and in
substance. In the process, it provides an opportunity for students to satiate
their inquisitiveness about the corporate world, exposure to practicing
professional skills and also helps them acquire social skills by being in
constant interaction with the professionals of an organization. This program
benefits students to understand what he/she has studied in the classroom and
what is being practiced in the industry.

Practice School involves task orientation, teamwork,

Your text here 1 goal orientation and
managing the interpersonal relationships. Therefore, it helps students to
develop the qualities required by a graduate. A good Practice School program
undertaken with all the seriousness provides an excellent learning
opportunity to the student and also paves the way for successful career path.

• Enables students to have a smoother transition from academics to

professional world.
• Enhances interpersonal skills, communication skills, leadership qualities
etc.
• Provides an opportunity to students to apply some of the ideas/skill sets
in their careers,which also enhances their confidence levels.
• Enables students to be aware of their personal strengths and limitations
as professionals.
• Increases marketability of students after graduation.
• Provides link with potential future employers.
Concept of Practice School

In the VII semester, every candidate shall undergo practice school for a period
of 150 hours evenly distributed throughout the semester.

The student shall opt any one of the domains for practice school declared by
the academic (program) committee from time to time.

At the end of the practice school, every student shall submit a printed report
(in triplicate) on the practice school he/she attended (not more than 25
pages). Along with the exams of semester VII, the report submitted by the
student.

The knowledge and skills acquired by the student through practice school
shall be evaluated by the subject experts at college level and grade point shall
be awarded.

Practice school in our curriculum

1. Basic Introduction

2. Scientific method

3. Application

4. Training

5. Research

6. Documentation
 PRACTICE SCHOOL ON INDUSTRIAL PHARMACY
(150 HOURS)

COURSE TOPICS DURATIO

MODULES N(HRS)
1) Pharma Industry and Pharmaceutics. 25 hrs
2) Preformulation
3) General aspects of formulation selection
• Physical and chemicals considerations.
• Buffer capacity.
• Partition coefficient.
• Solubility and PH.
• The phase rule.
• Melting point depression.
• Age and sex of patient.
Module-1
4) Steps in Pharmaceutical Research
• Discovery.
• Product Characterization.
• Formulation, Delivery, Packaging
Development.
• Pharmacokinetics and Drug Disposition.
• Preclinical Toxicology Testing and INDA.
• Bioanalytical Testing.
• Clinical Trials.

Instrument handling: 50 hrs

• SOP Handling
• Tablet compression
• Dissolution Apparatus
• Friability Tester
• Tapped density apparatus
Module–2 • Monsanto Hardness testing
• Fluidized bed processor
• Spray dryer
• Freeze dryer
• Aerosol filling machine
• High speed homogenizer (Ika ultra turrex
T25)
 Formulation (Conventional) 25 hrs

Tableting in Industrial Aspect

• Literature Search
• Requirement Short listing
• Vendor selection
Module–3 • Providing Control number and documentation.
• Preformulation
• Trail batch and optimization
• Lab Validation.
• Scale up validation
• Tech Transfer
• Regulatory clearance in detail
Novel Drug Delivery 25hrs

• Development and evaluation of bovine serum

albumin microspheres loaded withdiclofenac
sodium
• Formulation and evaluation of diclofenac gel
• Formulation and comparative evaluation of
Module–4 sustained release diclofenac sodium matrixtablets
• Formulation and evaluation of niosomes by thin film
hydration technique
• Formulation and evaluation of gelatin microspheres of
diclofenac sodium
• Formulation and evaluation of liquid crystalline
nanoparticle by using High speedhomogenizer
(Ika ultra turrex T25)
Quality control, Regulatory Affairs, Industry
needs 25hrs

• Dissolution
Module–5 • Basic consideration
• Basic of Pharmaceutical regularity affairs
• Role of regularity profession in industry
 PRACTICE SCHOOL ON PRECLINICAL PHARMACOLOGY
AND TOXICOLOGY (150 HOURS)

COURSE TOPICS DURATION

MODULES (HRS)
Module-1 Phases of Drug Development:
Drug Discovery, Characterization of investigational
drug, Formulation of investigational drug,
Pharmacokinetics aspect and Drug Disposition, 20 Hrs
Preclinical Toxicity studies and Investigational New
Drug (IND) Application, Bioanalytical Testing and
Clinical Trials.
Module–2 Historical Approaches in Drug Discovery
Indian system of Traditional medicines like Ayurveda,
Siddha and Unani, traditional Chinese medicine, and 10 Hrs
European Galenic medicine.

Module–3 New Approaches in Drug Discovery

Combinatorial Chemistry, High-Throughput Screening,
10 Hrs
Ultra-High-Throughput Screening and High-Content
Screening.
Module–4 The Committee for the Purpose of Control and
Supervision of Experiments on Animals (CPCSEA)
Guidelines for the Care and Use of Laboratory
Animals:
Goal, Veterinary Care, Quarantine, Stabilization and
Separation, Surveillance, Diagnosis, Treatment and
Control of Disease, Animal Experimentation Involving
Hazardous Agents, Durations of Experiments, Physical
Restraint of Animals for Examination, Functional
Areas of Animal House, Physical Facilities of Animal
10 Hrs
House, Environment (A) Temperature and Humidity
Control (B) Ventilation (C) Power and Lighting
(D) Noise Control, Animal Husbandry (A) Caging or
Housing System (B) Social Environment, Animal Food
and Water, Bedding, Sanitation and Cleanliness,
Waste Disposal, Record Keeping in the Animal House,
Animal Facility Staff and Their Training, Anesthesia
and Euthanasia Methods used in Experimental
Animals.
Module–5 Preclinical Study:
Types of Preclinical Testing, Important Consideration of
Conducting Preclinical Studies, Steps Involved in
Preclinical Trials, Safety Pharmacology, Toxicity 20 Hrs
Studies such as Acute, Subacute, Chronic,
Inhalational, Dermal, Reproductive and Carcinogenic
Toxicity Studies.
Module–6 Animal Models in Preclinical Research:
The Animal Models used to screen Analgesic, Anti-
Inflammatory, Antipyretic, Local Anesthetic, Antiulcer,
Antiemetic, Antidiarrheal, Antiasthmatic, Antiallergic,
Antifertility, Aphrodisiacs, Muscle Relaxant,
Anticonvulsant, Antipsychotic, Antidepressant, 60 Hrs
Antianxiety, Antiparkinsonian, Nootropic,
Antihypertensive, Antiarrhythmic, Antihyperlipedimic,
Antihyperglycemic, Hepatoprotective, Diuretic, and
Anticancer activities.
Module-7 Biostatistics in Preclinical Studies:
Introduction to Biostatistics in Preclinical studies,
Types of data, Summarizing the data, Describing data
20 Hrs
& Normality Selection, Statistical tests (Parametric and
Nonparametric), Hypothesis testing & Significance level
(p-value) and Data presentation.
 PRACTICE SCHOOL ON PHARMACEUTICAL
REGULATORY AFFAIRS (150 HOURS)

COURSE TOPICS DURATION

MODULES (HRS)
Module-1 Introduction to Regulatory Affairs
General terminology, Roles and Responsibilities of RA 10 hrs
in Pharmaceutical Industry, Regulatory guidance
documents, Rules and Regulations, New
amendments in pharmaceutical regulations.
Module–2 Introduction to Regulatory Authorities
25 hrs
Over view of Regulatory authorities and their role and
responsibilities including its organization chart:
India, USA, EU, Canada, Japan, Australia.

Module–3 Introduction to ICH

25 hrs
Over view of ICH Guidelines: QSEM (Quality, Safety,
Efficacy and Multi disciplinary. Introduction to CTD
(Common Technical Documentation) and eCTD
(Electronic Common Technical Documentation)
Module–4 Introduction to Regulatory Approval Process
Approval Process and timelines involved in IND 50 hrs
(Investigation of New Drug), NDA (New Drug
Application), ANDA (Abbreviated New Drug
Application ) and BLA (Biological License Application).
Module–5 Introduction to Clinical Trails 20 hrs
Over view of Non – clinical and Clinical trials, Clinical
trial protocol development, Institutional Review
Board, Role and Responsibilities of Sponsor and
Investigators and Safety monitoring in clinical trials.
Module–6 Introduction to General Regulatory Concepts
20 hrs
Orange Book, Purple Book, Federal Register and
Code of Federal Register. DMF (Drug master Files),
Annual Reports, Changes to an Approved
NDA/ANDA.
 PRACTICE SCHOOL ON HOSPITAL PHARMACY
(150 HOURS)
COURSE DURATION
TOPICS
MODULE (HRS)
Introduction
1. Pharmacy practice and pharmaceutical care
2. Rational use of drugs
3. Hospital pharmacy and role of hospital pharmacist
Module–1
4. Clinical pharmacy and evidenced based medicines 25hrs
5. Pharmacovigilance
6. Public health and. pharmacoepidemiology
7. Introduction to clinical research and basic clinical
trials
Community Pharmacy
1. Requirements and licensing procedure to establish
community pharmacy
2. Treating of minor ailments
3. Health screening techniques
Module–2 25hrs
4. Arrangement of drugs in community pharmacy
5. Indent keeping
6. Dispensing of medicines
7. Inventory control at Janaushadi Kendra
8. OTC medications
Clinical and hospital pharmacy
1. Inventory control
2. Processing drug information queries.
3. Assessment of drug related problems
Module–3 4. Patient counseling and preparation of leaflets 25hrs
5. Interpretation of laboratory data
6. PMH interviews
7. Patient medication adherence
8. Preparation of essential drug list for a hospital
 Clinical research and Pharmacovigilance
1. Clinical trial rule 2019.
2. Good clinical Practice ICH, GCP, CDSCO
guidelines
3. Designing of clinical study documents
Module–4 4. Safety monitoring in clinical trials. 50hrs
5. Ethics in clinical trials
6. Declaration of Helsinki and Belmont report
5. Practical aspects of ADR identification,
monitoring, reporting and management
6. Pharmacovigilance
Public health and basics research methodology
1. Vaccination schedule
2. Calculating the Determinants of health
3. Sustainable developmental goals
4. National and international health organizations
5. Communicable diseases and Role of pharmacist in
Module–5 25 hrs
preventing communicable diseases.
6. Community awareness on national health
programmes.
7. Balanced diet and nutritional deficiency disorders
8. Types of data
9. Usage of graphpad instat and SPSS Softwares.
 PRACTICE SCHOOL ON PHARMACEUTICAL ANALYSIS
(150 HOURS)

COURSE TOPICS DURATION

MODULES (HRS)
Module-1 Introduction to Pharmaceutical Analysis
General introduction of analysis in Pharmacy.
Types of analysis in pharmacy. Different
techniques of analysis. Importance of analysis in
pharma industry.Importance of Pharmacopeia in
analysis
Introduction to Standard operating procedures
in analysis 20hrs
1.Study of SOP 2.Preparation of SOP
3.Importance of SOP
Preparation of Reagents and Standard
solutions
Importance of reagents and standard solutions in
analysis.
Module–2 Theory, Principle, Instrumentation,
Application of following Analytical
Instruments
1.Analyticla balance 2.pH meter 3.UV Visible
spectroscopy
4. IR spectroscopy 5.Fluorimetry 6.High 25hrs
performance liquid chromatography 7.HPTLC 8.DSC
9.Dissolution 10.Particle size analyzer 11.NMR
12.Mass spectroscopy 12. Analytical method
validation.
Module–3 Operation and Handling of Analytical
Instruments
1. Analytical balance 2. pH meter
3. UV Visible spectroscopy
45hrs
4. IR spectroscopy 5. Fluorimetry
6. High performance liquid chromatography
7.HPTLC 8.DSC 9.Dissolution 10.Particle size
analyzer
Module–4 Preparation of Analytical Methods For Various
Drugs
1. Selection of drugs 2. Collection of Monographs
3. Literature Search 4. Selection of equipment 25hrs
5. Method Development 6. Method Validation
7. Quantification of Drugs.

Module–5 Calibration of Analytical Instruments

1. Definition and importance of calibration in
pharmacy.
2. Calibration of Glassware
3. Calibration of following instruments:
1. Analytical balance 2. pH meter 3. UV Visible 25hrs
spectroscopy
4. IR spectroscopy 5. Fluorimetry
6. High performance liquid chromatography
7. HPTLC 8. DSC
Module-6 Good Documentation Practice
1. Writing of Laboratory Note Book
10hrs
2. Preparation of Protocols
3. Preparation of Validation Reports