Diploma in Pharmaceutical Education

PHARMACEUTICAL MANAGEMENT

Time Duration: 18 Months.
Module 1 - Overview of Pharmaceutical Industry.
Module 2 - Medical Sciences for Pharmaceutical management.(Anatomy, Physiology, Patho physiology & Industrial Pharmacology).
Module 3 - Marketing Management. & Information Technology.
Module 4 - Financial & Management Accounting.
Module 5 - Mathematics ,Statistics & Economics for Management.
Module 6 - Communication and Personality Development.
Module 7 - Advanced Biosciences.
Module 8 - Financial & Human Resource Management.
Module 9 - Legal & Regulatory aspects of Pharma Business.
Module 10 - Marketing Research including Prescription Research.
Module 11 - Operations Management.
Module 12 - Quality Management & Manufacturing Strategy.
Module 13 - Strategic Management. Values, Ethics, Corporate Governance and Citizenship.
Module 14 - DBMS, Application of ERP & E Business. International Marketing.
Module 15 - R & D Management with focus on IPR & Patenting and Clinical Trial Research.
Internship : 3 months Practice Training in a Pharma company.
Time Duration: 18 Months.
Module 1 - Overview of Pharmaceutical Industry.
Module 2 - Medical Sciences for Pharmaceutical management.
Module 3 - Evolution Of The Indian Pharmaceutical Industry.
Module 4 - Basics Of Marketing. Designing Marketing Strategies.
Module 5 - Market Research. Methods of Forecasting.
Module 6 - Pharmaceutical Sales Management.
Module 7 - Preparation Of Annual Revenue Budget And Importance Of Achieving Sales Objectives.
Module 8 - Preparation Of Annual Expense Budget, Monitoring Expenses And Achieving Profit Objectives.
Module 9 - Communication & Reporting in Method For Pharmaceutical marketing.
Module 10 - Advance Marketing. Market Entry Strategies.
Module 11 - Marketing of Medical Devices and Vaccines.
Module 12 - Distribution Management And Logistics.
Module 13 - IPR & Patenting ,Patents And TRIPS.
Module 14 - Future of The Industry.
Module 15 - Introduction to International Marketing.
Internship : 3 Months Practice Training in a pharma corporate.
Power-Point Presentation.
Public Speaking / Group Discussion.
Case Studies Presentation.
Conducting Perception Study.
Role Playing Sessions-IR Issues And Motivation.
Writing Circulars and Motivating Letters.
New Product launch.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry and Product Management.
Module 2 - Medical Sciences for Pharmaceutical management. (Anatomy, Pharmacology and Microbiology).
Module 3 - Principles of Pharmaceutical Management & Brand Management.
Module 4 - New Product Packing Arts design and development.
Module 5 - Basics Of Marketing. Designing Marketing Strategies.
Module 6 - Market Research. Methods of Forecasting.
Module 7 - Managing Human Resources.
Module 8 - Business Communication & Reporting system in Pharma Industry.
Module 9 - Basic concept of Pharmaceutical Manufacturing & Regulatory Affairs and IPR.
Module 10 - Promotional activity in pharmaceutical marketing.
Internship : 2 months Practice Training in a pharma company.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry and MSR.
Module 2 - Medical Sciences for Pharmaceutical management.(Anatomy, Pharmacology and Microbiology).
Module 3 - Principal and Practice of Pharmaceutical sales Management.
Module 4 - Personality Development.
Art Of Communication.
Personal "SWOT" Analysis.
Self Representation.
Self Atitute.
Body Language.
Speaking and Group Discussion.
Module 5 - Visual Aid Presentation to doctor and Product Knowledge.
Module 6 - Facing The Interview Panel.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry and pharmaceutical import-export management.
Module 2 - Principles and Practice of Pharmaceutical Management.
Module 3 - Back Ground of Pharmaceutical Industry in India.
Module 4 - Rules and Regulations for Import and Export.
Module 5 - Pharmaceutical Imports.
Module 6 - Basics of Pharmaceutical Exports.
Module 7 - Pharmaceutical Export Costing and Finance.
Module 8 - Pharmaceutical Export Documentation and Procedure
Module 9 - Pharmaceutical Export Production Packing and Shipping.
Module 10 - Pharmaceutical Export Project Report.
Module 11 - 2 months practical training.
Pharmaceutical RA and R&D

Time Duration: 12 month.
Module 1 - Overview of pharmaceutical industry.
Module 2 - Introduction about Research and Clinical trial.
Module 3 - Introduction about NDA, ANDA, INDA ,DMF.
Module 4 - Introduction to Drug Discovery and drug Development.
Module 5 - Basic pharmacology and clinical research : Basic conceptual knowledge about receptors, drugs, preclinical studies, pharmacodynamic, pharmacokinetic (ADME), drug interactions.
Module 6 - Clinical trials New drug discovery process- purpose, main steps involved in new drug discovery process, timelines of each steps, advantages and purposes of each steps, ethics in clinical research, unethical trials, thalidomide tragedy, Phase-I, II, III, IV trials.
Module 7 - Introduction and designing -Various phases of clinical trials -Post Marketing surveillance – methods -Principles of sampling -Inclusion and exclusion criteria . Methods of allocation and randomization -Informed consent process in brief.
Module 8 - Monitoring treatment outcome -Termination of trial -Safety monitoring in clinical trials.
Module 9 - Pre clinical toxicology: General principles, Systemic toxicology (Single dose and repeat dose toxicity studies), Carcinogenicity, Mutagenicity, Teratogenicity, Reproductive toxicity, Local toxicity, Genotoxicity, animal toxicity requirements.
Module 10 - Basic terminology used in clinical research: Types of clinical trials, single blinding, double blinding, open access, randomized trials and their examples, interventional study, ethics committee and its members, cross over design, etc...and Institution Ethics Committee / Independent Ethics Committee Data Management in clinical Research.
Module 10 - TWO Months Training in R & D Center.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry , Clinical Research and Data management.
Module 2 - Clinical Research Introduction , Principles of Pharmacology & Drug Discovery & Development , Roles & Responsibilities of Key Stakeholders, Preparations & Planning for Clinical Trials.
Module 3 - Introductions to Data Management, Data Management Plan, Documents, guidelines used in CDM , Study Set Up, CRF (Case Report Form ) Design Considerations , Identifying and Managing Discrepancies, Medical Coding.
Module 4 - Introduction to Clinical Database, Database Closure, Clinical Database & Types. Database Design (Introduction) • Edit Check & Edit Check Testing.
Module 5 - The CDM Process, Review and finalization of study documents. Database designing, Data collection, CRF tracking, Data entry, Data validation, Discrepancy management.
Module 6 - Electronic Data Capture, Tracking CRF Data, Managing Lab Data, Collecting Adverse Event Data, Creating Reports and Transferring Data , e Enterprise Clinical Data Management Tools.
Module 7 - Clinical Data Analysis and Reporting Using Clinical Data Management Software, Data Entry, Data Review/Data Validation, Query Management, Data base QC , CRF Design (Introduction) ,UAT (User Acceptance Testing) , SOPs , Quality Assurance, Audits.
Module 8 - Introduction to Tools for CDM (Clinical Data management ), Clinical Data Management Systems (CDMS), ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite, OpenClinica, openCDMS, TrialDB, and PhOSCo.
Module 9 - General Introduction to SAS.
Module 10 - Regulations, Guidelines, and Standards in CDM.
Internship - TWO Months Training in R & D Center.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry. and Pharmacovigilance, Introduction, history, Important and Development of Pharmacovigilance. National and international scenario ( Pharmacovigilance in India)
  • Pharmacovigilance global perspective.
  • WHO international drug monitoring programme.
Module 2 - Introduction to adverse drug reactions, Definitions and classification of ADRs, Detection and reporting, Causality assessment, Severity and seriousness assessment, Predictability and preventability assessment, Management of adverse drug reactions.
Module 3 - Methodologies in Pharmacovigilance, Passive surveillance "Spontaneous reports and case series, Stimulated reporting, Active surveillance“ "Sentinel sites, drug event monitoring and registries, Comparative observational studies "Cross sectional study, case control study and, cohort study Targeted clinical investigations, Vaccine safety surveillance, terminologies of Adverse medication related event, Regulatory terminologies, Basic drug information resources, Specialized resources for ADRs, Critical evaluation of medication safety literature.
Module 4 - Establishing pharmacovigilance programme - Establishing in a hospital, Establishment, operation of drug safety department in industry Establishing a national programme.
  • SOPs  "Types, designing, maintenance and training.
  • Roles and responsibilities in pharmacovigilance.
  • o Licence Partners, o Contract Research Organizations (CROs) and o Market Authorization Holders (MAH).
Module 5 - Identification of new adverse drug reactions, Signal detection in pre and post marketing period, Prioritization and risk assessment, Risk management, Seriousness & Expectedness & Causality Assessment Criteria.
Module 6 - Drug and disease classification- Anatomical, therapeutic and chemical classification of drugs, International classification of diseases, Daily defined doses, International Non proprietary Names for drugs.
Module 7 - Drug dictionaries and coding in pharmacovigilance - WHO adverse reaction terminologies, MedDRA and Standardised MedDRA queries, WHO drug dictionary, Eudravigilance medicinal productdictionary.
Communication in pharmacovigilance - Effective communication in Pharmacovigilance, Communication in Drug Safety Crisis management.
  • Communicating with Regulatory Agencies, Business Partners, Healthcare facilities, Media & Dear Doctor Letters to Healthcare Professionals.
Module 8 - Introduction to Argus, Introduction to Aris G Pharmacovigilance and safety, Basic Prescribing Information (BPI) Labelling, EMEA labeling, Investigator'™s Brochure (IB) Labelling. Event verbatim, CTCAE guidelines, Case Narratives.
Statistical methods for evaluating medication safety data , Pharmacogenomics of adverse drug reactions.
Module 9 - Safety data generation -Pre clinical phase, Clinical phase, Post approval phase.
Safety monitoring during clinical trials - Need for safety monitoring and terminologies, Monitoring of safety, Key players and their responsibilities, Causality assessment of adverse events, Communication of safety information.
Drug safety evaluation in special population  "Paediatrics, Pregnancy and lactation, Geriatrics.
Module 10 - Organizations Guideline and pharmacovigilance ,ICH Guidelines for Pharmacovigilance, CIOMS.
  • US FDA and Pharmacovigilance.
  • o CFR requirements o Guidance for pre approval pharmacovigilance of prescription drugs o Guidance for post approval pharmacovigilance of prescription drugs o Guidance for pharmacovigilance of non prescription drugs o Good pharmacovigilance practice o Risk Evaluation and Mitigation Strategy.
  • EMEA (Europe) and Pharmacovigilance.
  • o Part I "Marketing authorization holders o Part II "Competent authorities and the agency o Part III "Electronic exchange of pharmacovigilance information in EU o Part IV" Pharmacovigilance communication.
  • MHLW (Japan) and pharmacovigilance.
  • Health Canada and Pharmacovigilance.
  • o Introduction o F&D and NHP Regulations o Guidance documents for pharmacovigilance.
  • CDSCO (India) and Pharmacovigilance.
  • o D&C Act and Schedule Y o Differences in Indian and global pharmacovigilance requirements.
Module 11 - Pharmacovigilance compliance and inspections - Conduct of pharmacovigilance inspections, Preparation for pharmacovigilance inspection, Importance of Regulatory Audit o Types of Regulatory Audits Planned Audits, Random Visits, Dos and Don'™ts Inspection reports and corrective actions. Quality Assurance (QA) aspects of Pharmacovigilance activities.
Module 12 - Case Study-
  • Designing of pharmacovigilance center.
  • Signal detection and risk assessment.
         (i)Causality assessment of adverse drug reactions.
         (ii)Case narratives.
         (iii)Safety reporting.
Time Duration: 12 months.
Module 1 - Overview of pharmaceutical industry. & Regulatory Affairs.
Module 2 - Introduction to NDA, ANDA,INDA ,MAA,DMF submissions, 505(b)(2) application Overview of GMP.
Module 3 - Introduction and Registration requirement of International regulatory agencies USFDA, MHRA, TGA ANVISA.
Module 4 - ICH Quality guidelines, ICH M4 Q CTD Format. ISO 9000 series.
Module 5 - DMF preparation: Module 2, Module 3, Regulatory Submission to US, DMF submission, Common deficiencies, Handling changes, Regulatory submission to Europe.
Module 6 - CEP approval, Module 1, 2 & 3, Addressing deficiencies, Revisions & renewal ,EDMF/ASMF.
Module 7 - WHO, Canada, Japan filling procedure, Dossier preparation in CTD format: Module 2, 3, 4 & 5.
Module 8 - ANDA approval process, Hatch-Waxman Law, - Regulatory Submission to Europe- Marketing Authorization procedures.
Module 9 - Patent, copyright, trademark, Geoghraphical Indication, Biodiversity, Unfair Competition, Industrial Designed, TRIPS andTRIMS.
Module 10 - Module 1 & 2, Common deficiencies, Variations ,Regulatory Submission to Semi Regulated Markets , Latin America (Brazil & Mexico).
Module 11 - ACTD submission, Regulatory Submission to India, Schedule- Y CDCSCO, eCTD Submissions.
Module 12 - Detail of CTD and ECTD .
PHARMACEUTICAL INDUSTRY COURSE

Time Duration: 12 months.
Module 1 - Overview of pharmaceutical industry.
Module 2 - Introduction to common word use in pharmaceutical industry: INDUCTION TRAING, ON JOB TRAINING, BMR, BPR, Master packaging Records, BMR, SOP, DEVIATION, LINE CLEARANCE, PRODUCT CHANGE, BATCH CHANGE, INCCIDENT, CLEANING ,CLEANING LOG, TEMP. RH LOG, MACHINE CLEANING LOG, MIX-UP, batch packing start-up. CAPA, Batch hold, Investigation report, Qualification and validation.
Module 3 - 21 CFR 211.130 - PACKAGING AND LABELING OPERATIONS.
Module 4 - PACKING MATERIAL: Primary, secondary and Tertiary packing material, Material code.
Module 5 - TYPE OF PHARMACEUTICAL PACKAGING
BLISTER PACKING, STRIP PACKING, BULK PACKING, AEROSOL PACKING, INJECTION PACKING, BOTTLE PACKING FOR SOLID ORAL, LIQUIED PACKING BOTTLE PACK.
Module 6 - PACKING MACHINE blistering, strining, Bottle filling machine, Injection filling, Filling machine for liquied dosage form, machine, cartonator, labeling machine, online checkweigher.
Leaktest operator, weighing balance.
Module 7 - PACKING PROCESS-Weigh, Inspection and receiving of bulk material from manufacturing department.
Request given for dispensing of packing material, Cross Checking of packing by packing officer, Receiving of packing material inside packing line, REJECTION HANDING AND LABELING.
Module 8 - Request given for issue of BPR, Checking of BPR, ENTERY PROCESSURE ON BPR, In-process during packing – In-process checking solid oral packing, bulk packing, aerosol packing, liquid bottle packing, injection packing.
Module 9 - PARAMATER CHECKING DURING STAR-UP OF BATCH PACKING.
Module 10 - Reconciliation of batch, Batch yield, packing yield. ,barcode , pharmacode, different from Barcode AND Pharmacode, 2D, Handover to packed batch to warehouse department.
Module 11 - Market complaint: Handing of market complaint, type of market complaint.
Module 12 - Sampling during Packing, Roll of QA in packing, Personnel management in the industry.
Module 13 - PROJECT REPOT.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry and QA.
Module 2 - GMP and GLP.
Module 3 - Qality assurance and Regulatory affairs.
Module 4 - Material Management.
Module 5 - Insight to ICH quality guidelines: ICH Q1, Q2, Q3, Q6, Q7.
Module 6 - Documentation control ,Qualification & Validation- Process, Cleaning, Water system.
Module 7 - Change Management system: Change Control, Deviations, CAPA.
Module 8 - Out of Specification results, Market Complaints and Recalls, Rejection Handling and Reuse of Material. Colure code for Status label on material.
Module 9 - Annual Product Review, GMP Inspections.
Module 10 - IPQA and it’s roll in manufacturing, Warehouse, packaging, Quality control.
Module 11 - Batch Release, Investigation in any deviation or anccident.
Module 12 - Case study.
Time Duration: 12 months.
Module 1 - Overview of Pharmaceutical Industry and Production Management.
Module 2 - Introduction to common word use in pharmaceutical industry: INDUCTION TRAING, ON JOB TRAINING, BMR, BPR, Master packaging Records, BMR, SOP, DEVIATION, LINE CLEARANCE, PRODUCT CHANGE, BATCH CHANGE, INCCIDENT, CLEANING ,CLEANING LOG, TEMP. RH LOG, MACHINE CLEANING LOG, MIX-UP, batch packing start-up. CAPA, Batch hold, Investigation report, Qualification and validation.
Module 3 - PARAMATER CHECKING DURING STAR-UP OF BATCH MANUFACRINING.
Module 4 - Manufacturing, equipment , excipient uses , In-process Test Required, Troubleshooting with flow chart of tablet, capsule.
Module 5 - Manufacturing, equipment , excipient uses , In-process Test Required, Troubleshooting withflow chart injection, ointment, Syrup, aerosol.
Module 6 - Dispensing method of raw and active material, sieving and standard sieving , shifting, granulation, dryining of granules & tablet.
Module 7 - Batch change over and Product change over. Cleaning method during batch and product change over. Batch yield and product yield.
Module 8 - Inspection Checklist for different doses form. 21 CFR 211. Co-relation with different department.
Module 9 - Good Manufacturing Practices in Pharmaceutical Industry.
Module 10 - Principles of Pharmaceutical Production Management.
Module 11 - Case study/Internship.
Time Duration: 12 months.
Module 1 - Overview of pharmaceutical Industry, Quality, Quality Assurance and Quality Control in pharmaceutical.
Module 2 - Department and responsibility of different section in QC department.
Module 3 - list of equipment, there use, working principal used in Q.C department in pharmaceutical industry.
Module 4 - 21 CFR PART 211, Qualification and Validation. Good laboratory practice (GLP).
Module 5 - Quality Assurance and Quality Control- Possible Problems and Fixes, Addressing Internal and External Quality Issues Complying with Govt. regulations.
Module 6 - Types of Quality Testing (models, types, procedures etc.), different type of report.
Module 7 - Quality Testing Tools and Techniques, sample collection, type of sample, sampling method.
Module 8 - Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000.
Module 9 - Total Quality Management and GMP, Quality Risk Management, Assessing Quality Concerns at Different Work Units or Areas.
Module10 - Setting up Quality Control Checks, Inspections and Audits.
Module 11 - Documentation, Good Documentation Practices, SOPs, Protocols, etc.
Module 12 - Case Studies.
Time Duration: 12 months.
Module 1 - Overview of pharmaceutical Industry and warehouse.
Module 2 - Good manufacturing practice. CFR 21, PART 211.
Module 3 - Key Issues in Warehousing. Supply- chain Management (SCM).
Module 4 - Warehouse and Warehousing.
Module 5 - Warehouse Distribution Center.
Module 6 - Warehouse Management and Performance Systems.
Module 7 - Materials Handling and Packaging.
Module 8 - Transportation.
Module 9 - Inventory Management for Organizational Effectiveness.
Module 10 - Key Elements of Logistics Management.
Module 11 - International Logistics.
Module 12 - Logistics and Information and Communications Technologies.
PHARMACEUTICAL RELATED LAW

Time Duration: 12 months.
Module 1 - Introduction to Intellectual Property: History, Concepts and Types.
Module 2 - International Treaties and Conventions for Protection of IPs.
Module 3 - Role of Intellectual Property in Growth, Development, Trade and Commerce.
Module 4 - Various types of Intellectual Property Rights: Trademarks Basic, Copyright Basics, Trade Secrets, Geographical Indications, Semi Conductors and Integrated Circuits, Industrial Design.
Module 5 - Protection & Maintenance of IP -
- Trademark: Statutes, Filing Procedure.
- Copyright: Statutes, Filing Procedure.
- Trade secrets: Protection.
- Patent: Statutes, Filing Procedure.
- TRIPS.
Module 6 - IP & Patent Litigation ,Patent Process via PCT.
Module 7 - IP & Patent Licensing ,Alternate Dispute Resolution.
Module 8 - Patent Searches (Patentability searches) , Patent Analytic (FTO, Invalidity, Landscaping, etc.), Claims and Specification Drafting, Patent Prosecution.
Module 9 - IP Valuation.
Module 10 - IP Portfolio Audit and Management.
Module 11 - Commercialization and issues related to technology transfer.
Module 12 - Case study.
Diploma in Pharmaceutical Formulation

Sr. no.

Module for Formulation (mfg & QA)

1

General Introduction to pharmaceutical  Industries :   

 Different types of documents and their uses

 Different types of documents and their uses

SOP (STANDARD OPERATING PROCRDURE),

Entry and exit procedure in pharma industry,gowning procedure, Document Entry procedure.

Log for log,  Training log, Master Batch  records, Master batch manufacturing records , Batch manufacturing record (BMR)

Master batch packaging records,), Batch packaging record (BPR), Cleaning log

Temperature humidity monitoring log, daily Calibration log, validation records.  CERTIFICATE OF ANALYSIS (COA).

6. Good manufacturing practices (GMP) , 21 CFR 211.

7.  Deviation (PLAN AND UNPLAN DEVIATION),  CAPA (corrective and preventive action), 8.Change control.

 9. Qualification. 10 Validation

11. Cleaning procedure of area and machine  during change over, Area and machine cleaning   Checking during changeover. LIne/area  clearance clearances,  batch Start-up and clearances. Different type of Labels and their importanceâ??s in pharmaceutical industry.  Different  type of contamination.

12. Changeover (Product change over, batch change over ).13. In-proeses Checking, Q.C. Sample, preserve sample, Intermediate product

test

3

General description of different department in formulation industries

 

A) Human resources department.b)  Manufacturing department.C) Packaging department.d) Quality Assurance (QA)

E) Quality Control (Q.C.)F) Warehouse -. Dispensing of raw and packing material.

G) Engineering department.    (AHU/HVACH) Security department.I) Safety Department

4

Different Type of pharmaceutical formulation : Manufacturing, equipment , excipient uses , In-process Test Required, Troubleshooting withflow chart of below dosage form.

Tablet mfg

Tablets- Introduction , MBR Collection, Dispensing of raw material

Area, equipment  Cleaningand and  line clearanceShiffining of material, Different type of shifter, steam jacket

Granulation and Granulator, Inprocess check, And Q.C. Releases

Drying , Mixining,Inprocess check ,And Q.C. Releases

Compression and compessining machine,Inprocess check,And Q.C. Releases

coating and coating pan,And Q.C. Releases report for NEXT STEP

Tablet prininting and tablet inspection machine,And Q.C. Releases report for packing.

Trouble and trouble shooting

test

Capsule mfg

Capsule-Introduction, type, excipient of capsule,Capsule cell for hard gelating capsule.

Raw material dispeninsing, Area , equipment cleaning and line clearances.

Capsule plate manufacrining machine and process, Inprocess -check

Capsule filling machine, process and its operation,And Q.C. Releases report for packing.

Trouble and trouble shooting

Test

Semi- solid mfg

B). Semi- solid formulation plant.  Ointment,  Cream.

Introduction to ointment, cream, raw material dispensing.

Mixing and prepation of intermedient product. Inprocess check.

Trouble and trouble shooting

 

C). Liquid oral â??     Syrup, suspension

Liquied dosage form

Introduction to Syrup, suspension, raw material dispensing,area, equipment  Cleaningand and  line clearance

Bolttle cleaning machine, Bottle inspection machine, mfg tank, bottle filling machine.

In-process check, trouble and trouble shooting  in machine and product.

Sterile product mfg

D). Sterile formulation pant â?? Ophthalmic preparation, Injection, powder Injection, water for injection, Form filling sealing (FFS).

Introduction of Sterile product, are classifcation, area sterization

Entery procedures of human and material in sterial area. Cleaning procedure and importances of cleaning specialy in sterial area

Water for Injction mfg, Injection bulk prepation, machine used for formulation of injection

Ampoule filling and sealing machine, Inprocess check, sterity and pyrogen test for injection

Opthalmic prepation and FFS Introduction , machine used , machineoperation , in-process, prolem and trouble shooting

E) .Miscellaneous formulation â??  Aerosol.

TEST PAPPER- Semi- solid, liquied and sterial product

Packaging

Pharmaceutical Packaging

Introduction to packaging, Importances of packaging, charectorstatic of packaging,Packing material . Primary packaging and secondry packaging area.

 Component of packaging ( GSM,Base film, lid film, Paper , leaflet, Carton, container , bottle, silica  gel, gum stick, bar code, pharmacode, 2-d code, scaner, 3- ply shipper, 5- ply shipper, shrink film, product sticker, material code, A.R. CODE, glass,aerosol )

Blister PACKING LINE and type of blister packing machine. Area, machine cleaning and clearances. Type of cleaning, process of cleaning, batch startup , paramater checking during bactch packaging start, In-process check.

Description  and change part of BQS Packing machine, Elmach packing machine

Description and change of strip packaging machine, Cartonator, Online checkweiger,

conyeyor belt, Printer, carton counting machine, shrink pack machine, shipper sealing machine, shipper weighing machine.recancillation, packaging yield .batch yield, Excess material returne in Warehouse.BPR Reviwe, batch transdered in warehouse.

 Bottle packaging line, labeling machine, counteck machine.,bottle cleaning machine,

Problem and trouble shooting during packaing

TEST PAPPER

RA

 Introduction to Different Regulatory  agency AND AUDIT PREPATION

A) General description of regulated and semi- regulated pharmaceutical market.B) USFDA.

C) MHRA, D) TGA.

E) ANVISA, MCC, and other regulatory agency.

 

Personnel behaviours and mently prepare for  for Industries.

 

labour unioun in industry,Beheviour with casual person, machine operartor, behaviour bose, mently prepare for industry

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