1 Types of Water. 1.2
2 Water Purification Technology. 1.3
3 Dosage Forms: Definitions. 1.4
4 Aerosols. 1.5
5 Capsules. 1.7
6 Creams. 1.8
7 Eye Drops. 1.9
8 Ointments. 1.10
9 Hard Gelatin Capsule Shells. 1.11
10 Gel. 1.12
11 Injectable Preparations. 1.13
12 Nasal Preparations. 1.16
13 Liquid Orals; Oral Powders and Oral Rehydration Salts. 1.17
14 Suppositories. 1.20
15 Tablets. 1.21
16 Pessaries. 1.24
17 Definitions of Various Dosage Forms. 1.25
18 Detergents and their Concentration used in Pharmaceuticals and Hospitals. 1.28
19 Disinfectants and their Concentration used in Pharmaceuticals and Hospitals. 1.29
20 Fumigation Technology for Industry and Hospitals. 1.30
21 List of Machineries and Equipments for Pharmaceutical Plant with Advanced Technology. 1.32
22 Lubricants and their Concentration used in Tablets. 1.36
23 Binders and their Concentration used in Tablets. 1.36
24 Preservatives and their Concentration used in Liquid Orals Preparations. 1.37
25 Preservatives and their Concentration used in Parenteral Preparations. 1.37
26 Preservatives and their Concentration used in Ophthalmic Preparations. 1.38
27 Pharmaceutical Technology (Processes). 1.38
28 Problems and Solutions in Tablet Manufacturing. 1.39
29 Sterilization Methods. 1.40
30 Sterilization Indicators including ISO 11140 & EN 867, ISO 11138 EN866. 1.42
31 Sieve Numbers and Particle Sizes. 1.46
32 Designations and Dimensions of US Standard and Tyler Standard for Sieves. 1.47
33 Grades (Types) of Powders. 1.48
34 Definitions of Storage Conditions as per IP 96. 1.49
35 USP : 4 types of Pharmaceutical Glass Containers - Type I, II, III and NP. 1.50
36 Hard Gelatin Capsules and Average fill Weight Capacities. 1.50
37 Limits of filled Volumes for Parenterals as per USP. 1.51
38 Siliconizing of Glass vials. 1.51
39 New Drug Development Stages and Clinical Trails 1.52
40 Rejection and Recovery in Pharmaceuticals. 1.56
41 Market Recall and Market Withdrawals of Drug Product. 1.58
42 List of Antioxidants. 1.60
43 Definitions of Pharmaceutical Standard and Normal Values. 1.61
44 Commonly used Pharmaceutical Words. 1.63
45 Latin Terms. 1.65
46 Weights and Measures 1.72
47 Units’ Conversions Tables: Weight, Volume, Length, Area, Capacity & All Miscellaneous Units. 1.75
48 Conversion Tables of Units : Length, Flow rates, Pressure, Vacuum, Volume, Mass & Pressure Conversion Chart. 1.85
49 Recommended Temperature and Relative Humidity for Pharmaceuticals, Dry Bulb Temperature, Wet Bulb Temperature, Dew Point Temperature, Relative and Absolute Humidity, Psychrometry, Equation and Conversions. 1.87

50 Equations and Conversions of Units. 1.89
51 Aseptic Process Validation (media fill). 1.91
52 Tablet Compression Machine Types (Tooling), Wear and Tare, Cleaning and Maintenance of Punches and Dies and Food Grade Lubricants. 1.100
53 Cleaning of all types of Clean Rooms. 1.105
54 Difference between Emulsion O/W and W/O Type and Identification test for Emulsions. 1.112
55 Difference between Flocculated and Non flocculated Suspensions. 1.114
56 Surgical Dressing: Cotton & Bandages. 1.115
57 Bowie Dick Test for Autoclave Validation. 1.121
58 Sterilization Values: F0,FH, D and Z values. 1.123
59 Calculation of ideal sterilization cycle time & overkill approach 1.125
60 Filtration Basic Concepts 1.127
61 Indian and International System of Numbering 1.129
62 Calculation of % Proof of Spirit and Alcohols 1.134

SECTION II
CURRENT GOOD MANUFACTURING PRACTICES ( cGMP), DRUG AND COSMETIC ACT 1940 . 2.1 – 2.392

1 Definitions of GMP, cGMP, QA and IPQC. 2.2
2 Certifications for Pharmaceuticals Industries. 2.4
3 US Federal Standard 209 E. 2.8
4 ISO -14644-1: 1999 (E) Classifications of Air Cleanliness. 2.9
5 ISO -14644-2 Clean Room Testing for Compliance. 2.10
6 US Federal Standard 209 E: Class Designation, Testing and Monitoring Reports. 2.11
7 Recommended Minimum Premises Area, Equipments and Machineries for Manufacturing and Testing of Drugs as per Schedule M (Old) and New Schedule M.
2.12
8 Calibrations. 2.19
9 Validations. 2.20
10 Process Validations. 2.21
11 Analytical Method Validations. 2.23
12 Cleaning Method Validations. 2.34
13 URS, FAT, DQ, SAT, IQ, OQ, PQ of Machine and Equipments 2.40
14 WHO GMP Minimum Document Check list. 2.48
15 Schedules from Drug and Cosmetic Act 1940. 2.49
16 Schedules from Drug and Cosmetic Rules 1945. 2.50
17 Food and Drug Administration (FDA) Licensing forms. 2.52
18 International Standards Organization ISO 9001: 2000 clauses. 2.54
19 Accelerated Stability Testing and Shelf life Calculation. 2.57
20 International Conference on Harmonization (ICH) and eCTD 2.58
21 WHO GMP and ICH Stability Testing Guideline for Drug Products. 2.72
22 Good Laboratory Practices. 2.80
23 Content of Master Formula Records as per WHO GMP and USFDA. 2.90
24 US FDA Drug Master files (DMF). 2.92
25 Preparation for WHO GMP Audit. 2.94
26 Clean Room Standards for Different Countries and Names. 2.102
27 Guidance for Preparation of Site Master File (SMF) (MHRA). 2.103
28 ISO (14001 : 1996) - Environment Management Systems Clauses. 2.115
29 Validation Master Plan. 2.116
30 Schedule M and it’s Implementation ( updated up to Jun.2005). 2.119
31 Validations of Laundering Process. 2.168
32 List of Important SOP in Pharmaceuticals. 2.171
33 Stability Testing Global Map(Stability Zones) 2.177
34 Cleaning Method Validation Protocol. 2.178
35 Analytical Method Validation Protocol. 2.187
36 Process Validation Protocol. 2.213
37 Stability Study Protocol (Long term, Short term & Photo stability). 2.223
38 Computer System Validation. 2.229
39 Intellectual Property Right : Patents copy right and Trade marks. 2.243
40 Quality Risk management with Protocol & Report 2.260
41 Bulk Drug GMP (API) – Indian. 2.293
42 Clean Room Fabric Specifications & Tests. 2.303
43 Neutral License codes for Export from States of India. 2.306
44 SUPAC Scale UP & Post Approval Changes : SUPAC. 2.308
45 Registration Dossier Contents 2.323
46 Technology Transfer Guidance 2.325
47 GAMP 5 2.350
48 Water System Validation And Qualification. 2.352
49 Quality Management System (GMP) Documentation 2.355
50 Product registration in International Market-Regulatory Filing. 2.363
51 Schedule L-I – Good Laboratory Practices 2.383

SECTION III
QC, QA, MICROBIOLOGY, AND BIOTECHNOLOGY 3.1 – 3.114

1 Solubility : Definitions as per IP 96. 3.2
2 Viscosity : Definition, Types and Units. 3.3
3 Chromatography: Definition, Types, Instrumentation, Principle and Applications. 3.5
4 Spectroscopy : Definition, Type, Instrumentation, Principle and Applications. 3.8
5 Calculation of PP caps wad Density. 3.13
6 Micro Organisms and Nutrient Medias. 3.14
7 Biotechnology. 3.15
8 Microbial Tests for Formulations : IP, USP and Drugs and Cosmetics Act 1940. 3.23
9 Sterility Testing Sampling Plan for Parenterals. 3.24
10 Formula for calculation of Mean, SD, and RSD for HPLC Methods. 3.25
11 Formula for Calculation of Mean, SD, and RSD for Titrimetry Methods. 3.27
12 Limits of Particulate matters for Parenterals. 3.28
13 UV light Dosage PPM dosing, Velocity Calculation and Dead legs for Water System 3.29
14 Reference Standards and Working Standards. 3.34
15 Guidance for Out of Specification (OOS). 3.39
16 Dissolution test Apparatus Calibrations. 3.41
17 Preservative Efficacy Test (PET) with Protocol. 3.45
18 Growth Promotion Test with Protocol. 3.65
19 Inoculums Preparations in Microbial Analysis. 3.84
20 General Guidance for HPLC Validation. 3.86
21 General Requirements for the Competence of Testing and Calibration Laboratories (IS-14874 : 2000, ISO/IES – 17025 : 1999). 3.91
22 Tolerance Limits for Weights Calibrations : OIML Recommendations. 3.92
23 Validation of Air Sampler used in Microbiology. 3.93
24 Analytical Method Technology. 3.98
25 Important Terms used in Microbiological Testing. 3.99
26 Frequently used Abbreviations in Pharmaceuticals. 3.101
27 Sieve : Calibration and Certification. 3.111

SECTION IV
ENGINEERING, MAINTENANCE, WATER AND AIR 4.1 – 4.100

1 Light Illumination (LUX) for Pharmaceutical Plant. 4.2
2 Clean room Lighting. 4.3
3 Colour coding for Pipelines and Gas lines. 4.4
4 Colour coding for Cylinders of Medical Gases. 4.7
5 Fire Extinguishers : Types and Applications. 4.8
6 Air Handling Units : CFM and Air Changes Calculation. 4.9
7 Stainless Steel Grades and Difference. 4.10
8 Calculations of US Gallon Per Minute and other Conversions for AHU and Standard Steam Flow Based on Pipe Size. 4.11
9 Environment Management and Related acts and Standard Values. 4.13
10 Effluent Water Treatment Technology. 4.18
11 ETP Water Testing (COD, BOD and other) 4.21
12 Drinking Water Standards as per EPA USA, WHO and BIS. 4.33
13 Pump Head Calculation and Factors of Pump Selections. 4.48
14 Pipe Friction Loss Data and Friction Loss in Valve and Fittings. 4.51
15 Air Handling Unit : Good Practices. 4.53
16 Friction Losses of Air in Pipe. 4.57
17 Air Carrying Capacities of Pipes. 4.58
18 Types of Industrial Gases Cylinders : Shape, Size and Capacities. 4.59
19 Maintaining of Defect Book and Planned Preventive Maintenance. 4.61
20 Pharma Hygienic Piping. 4.68
21 Pure Steam Quality 4.75
22 AHU : construction, Component & Validation 4.77
23 Design & Training – Water purification technology 4.89
24 Water pipe line – slope measurement & limit. 4.98
25 Brine Concentrations and Freezing Point 4.99

SECTION V
PHYTO PHARMACEUTICALS (PHARMACOGNOSY), PHARMACOLOGY, MEDICINAL CHEMISTRY AND PHYSIOLOGY (INFORMATION FOR PHYSICIANS, NURSES.) 5.1 to 5.62

1 Ayurvedic Dosage Forms. 5.2
2 Methods of Evaluations of Crude Drugs. 5.5
3 Physical Methods of Evaluations of Crude Drugs (Various Values). 5.6
4 Cultivation of Medicinal Plants. 5.9
5 Definitions of Medicinal and Pharmacological Terms. 5.11
6 Calculation of Expected Date of Delivery. 5.18
7 Drugs to be Avoided in Pregnancy. 5.19
8 Drug S to be Avoided in Lactation. 5.20
9 Immunization Schedule for Children. 5.21
10 Eruption of Teeth and Height Weight Chart for Children. 5.22
11 Table of Average Blood Pressure. 5.23
12 Respiration Rates at Various Ages. 5.24
13 Vitamins: Sources, Daily Requirements, Deficiency Diseases. 5.25
14 Heterocyclic Compounds: Nomenclature and Structure. 5.26
15 Crud Drugs : Name, Family, Main Chemical Constituents and Category. 5.34
16 Drugs : Mode of Action, Market Names and Uses. 5.39
17 Pentose Phosphate Pathway Reaction. 5.60
18 Essential Fatty Acid, Amino Acids and Elements for Human Nutrition. 5.61
19 Citric Acid Cycle Balanced Reaction. 5.62

SECTION VI
STORES AND DISTRIBUTION 6.1 – 6.18

1 Material Management & Good Storage Practices (WHO GMP). 6.2
2 Pharmaceutical Industrial Stores : Including Dispensing and Other Systems. 6.6
3 Medical Stores. 6.14
4 Hospital Stores. 6.16
5 Requirements for Obtaining Sealing License from FDA. 6.17

SECTION VII
JOB, EMPLOYMENTS AND PERSONALITY DEVELOPMENT 7.1 – 7.16

1 Scope of Pharmacy Degree and Diploma in Pharmacy. 7.2
2 How to Face Interviews and Personality Development. 7.3
3 Important Pharma, Agro and Related Website. 7.10
4 Model Question Paper for Drug Inspector Exam. 7.13
Bibliography 1 – 4

Important Telephone Numbers and Notes 1 – 14