I am going to send you my one-word questions from my syllabus.

I want you to act as my rapid-fire one-word exam coach.

STEP 1 — ANSWER MY QUESTIONS

First, go through all the one-word questions I send.

Give me the correct answer for every question.

Keep each answer:

Very short

Accurate

Easy to memorize

Exam-oriented

Use this format:

1. Question: ______ Answer: ______

Do not give long explanations unless an answer is confusing or needs clarification.

STEP 2 — CREATE ADDITIONAL QUESTIONS

After answering my questions, analyze my syllabus and create additional important one-word questions that are NOT in my list.

Focus on things that are likely to be asked, such as:

Full forms

Abbreviations

Definitions

Important terms

Organizations/agencies

Guidelines

Standards

Important names

Important numbers/years, if relevant

Functions/roles

One-word concepts

Clearly label these as "AI-added important questions."

STEP 3 — TEST ME

Now start testing me.

Mix my original questions + AI-added questions randomly.

Do NOT follow the order in which I sent them.

Ask me ONE question at a time and wait for my answer.

Example:

Question 1: What is the full form of TQM?

I answer.

If correct: ✅ Correct! — Total Quality Management

Then immediately ask the next question.

If wrong: ❌ Wrong. Correct answer: Total Quality Management

Give me a very short memory trick, then continue.

STEP 4 — REPEAT MY WEAK QUESTIONS

Keep track of the questions I get wrong.

Bring those questions back later in a random order until I answer them correctly.

Do NOT repeatedly ask questions I already know well.

STEP 5 — MIX EVERYTHING

Keep continuously mixing:

My original questions + AI-added questions + previously incorrect questions

so I cannot simply memorize the sequence.

Every 20 questions, tell me:

Score: __/20

Weak areas: ______

Then continue testing me.

FINAL ROUND

After we have covered all my questions, give me a final rapid-fire test containing:

My most important original questions

Questions I got wrong

AI-added high-probability questions

Questions from all units mixed together

Finally, give me a Last-Minute Revision List containing only the answers I absolutely need to remember before entering the exam hall.

IMPORTANT: I have very little time. Do not waste time with long explanations. Keep everything fast, simple, interactive and exam-focused.

I will now send you my one-word questions. Do not start the test until you have first given me the answers to all the questions I send.

SUPAC does not deal with changes in a) Site b) Process and equipment c) Manufacturers d) Composition CO1 BTL1 14 What is CTD? a) Common Technical Document b) Common Technical Dossier c) Common Technical Development d) All of the above CO1 BTL1 15 Pilot plant is an integral part for a) Technology evaluation b) Scale up c) Transfer activities d) All of the above CO1 BTL1 16 WHO guidelines for technology transfer means a) Development for transfer with documentation b) Technical document transfer c) Govt organisation monitoring pharmacy d) New storage system CO1 BTL1 17 Which is not a scale up process? a) Laboratory to pilot-scale b) Pilot-scale to industrial scale c) Industrial to pilot-scale d) Laboratory to industrial scale CO1 BTL1 18 Expansion in CROs reflect? a) Balance workload b) Reduce investment c) Build in-house capability d) All of the above CO1 BTL1 19 Pilot CoPP is issued by a) GMP b) US FDA c) WHO d) CDSCO CO1 BTL1 20 Part of pilot plant operation? a) Validation b) Training c) Manufacturing activity d) All of the above CO1 BTL1 21 Not a space requirement? a) Physical testing area b) Standard equipment floor space c) Storage area d) Raw material CO1 BTL1 22 QRM ICH guideline? a) Q7 b) Q8 c) Q9 d) Q10 CO1 BTL1 23 CoPP format recommended by a) GMP b) FDA c) WHO d) All of the above CO1 BTL1 24 Pilot CoPP issued by a) GMP b) US FDA c) WHO d) CDSCO CO1 BTL1 25 Scale up means a) Increasing batch size b) Decreasing batch size c) Increasing production rate d) Increasing quality CO1 BTL1 26 Scale down means a) Increasing batch size b) Decreasing batch size c) Increasing production rate d) Increasing quality CO1 BTL1 27 Not a space requirement? a) Physical testing area b) Storage area c) Raw material d) Standard equipment floor space CO1 BTL1 28 Part of pilot plant operation a) Validation b) Training c) Manufacturing activity d) All of the above CO1 BTL1 29 SU to RU info for liquid dosage a) pH & viscosity b) Specific gravity c) H2O content d) All of the above CO1 BTL1 30 Laboratory accreditation system a) ISO b) WHO c) NABL d) GMP CO1 BTL1 31 Other name of dry granulation a) Mixing b) Reduction c) Slugging d) Blending CO1 BTL1 32 Scale-up parameter for FBD a) Optimum load b) Air flow c) Inlet air temp & humidity d) All of the above

i want question answer with options...again givr it

c) Industrial to pilot-scale

d) All of the above

c) Manufacturers

b) ICH Q8

c) NABL

Technology transfer is a) Purpose orientated
b) process orientated c) Technology orientated
d) Commercial orientated CO2 BTL1

2

Research phase of technology transfer involved a) Design of procedure b)Selection of excipients
c) Identification of excipients d)All the above

CO2

BTL1 3 Types of technical transfer involves CO2 BTL1 Q.No Question (Short Title) CO BTL 1 Technology transfer is a) Purpose orientated
b) process orientated c) Technology orientated
d) Commercial orientated CO2 BTL1 a) Vertical b) Horizontal
c) Both a&b d) None 4 Basic requirement of technology transfer a) Sending Unit (SU) b) Receiving Unit (RU) c) Both d) None of these CO2 BTL1 5 Technology transfer between different companies a) Intercompany transfer b) Intra company transfer c) Technology transfer d) Technology transfer protocol CO2 BTL1 6 MoU stands for a) Memorandum of Ubiquitous
b) Memorandum of understanding
c) Memorandum of unpredictable d) Memorandum of unprofitable CO2 BTL1 7 Methods generally used in liquid filling a) Gravimetric b) Volumetric c) Constant level method d) All of the above CO2 BTL1 8 Filling method of pharmaceutical liquid depends on a) Viscosity of the liquid
b) Surface tension of the liquid CO2 BTL1 Q.No Question (Short Title) CO BTL 1 Technology transfer is a) Purpose orientated
b) process orientated c) Technology orientated
d) Commercial orientated CO2 BTL1 c) Compatibility with the material used in the construction of the filling machine
d) All of the above 9 Information provided by SU to RU for liquid dosage form A) Range of pH and viscosity b) Specific gravity
c) H20 content d) All of these CO2 BTL1 10 Primary focus of Phase III clinical testing a) How to manage costs
b) The optimal range of effective dosage
c) The collection and analysis of highly specific efficacy end point data
d) The analysis of data results from the small-subset target population CO2 BTL1 11 FDA classification criteria for NDA a) Novelty of the active ingredient and time market
b) Balance between safety and effectiveness
c) Novelty of the active ingredient and clinical improvement
d) Clinical improvement and effectiveness of product CO2 BTL1 12 Quality Management Systems deal with a) Quality for their products and services
b) Safety for their products and services
CO2 BTL1 Q.No Question (Short Title) CO BTL 1 Technology transfer is a) Purpose orientated
b) process orientated c) Technology orientated
d) Commercial orientated CO2 BTL1 c) Quality and safety for their products
d) Quality and safety for their product and services 13 Definition of Quality Control a) Sampling and documentation b) Sampling, specification and documentation c) Sampling, specification, testing, documentation and release procedures
d) None of these CO2 BTL1 14 Study leaders during clinical trial a) Chief medical officer and clinical research associates. b) Principal investigators and study coordinates
c) Study coordinates and chief medical officer
d) Principal investigators and clinical research associates. CO2 BTL1 15 SIDBI was developed on a) 2 April, 1990 b) 2 April, 1991
c) 2 April, 1992 d) 2 April, 1993 CO2 BTL1 16 Purpose of the Case Report Form (CRF) a) To ensure data accuracy by providing a place to store warehouse patient data for audit purposes b) To provide a reference for all study subjects from which to analyze patient data
CO2 BTL1 Q.No Question (Short Title) CO BTL 1 Technology transfer is a) Purpose orientated
b) process orientated c) Technology orientated
d) Commercial orientated CO2 BTL1 c) To include in the NDA filing
d) All of the above 17 At the end of the study, What happens to CRFs at the end of the study a) The CRF data is complied and submitted to the FDA in the IND.
b) The CRF data is aggregated by an external party if the trial was double blinded to assess the drug’s safety and efficacy
c) The CRF data is aggregated and analyzed to assess the drug’s safety and efficacy.
d) The CRF data is compiled and submitted to Regulatory Affairs CO2 BTL1 18 On which two criteria does the FDA classify NDAs?
a) Novelty of the active ingredient and time to market
b) Balance between safety and effectiveness
c) Novelty of the active ingredient and clinical improvement d) Clinical improvement and effectiveness of product CO2 BTL1 19 Pilot plant is an integral part for
a) Technology evaluation b) Scale up
c) Transfer activities d) All of the above

CO2 BTL1 20 NDA takes CO2 BTL1 Q.No Question (Short Title) CO BTL 1 Technology transfer is a) Purpose orientated
b) process orientated c) Technology orientated
d) Commercial orientated CO2 BTL1 a) 12 years b) 15 years
c) 10 years d) 5 years 21 Technology transfer between sites of different companies a) Inter company transfer b) Intra company transfer
c) Technology transfer d) Technology transfer protocol CO2 BTL1 22 Binding to die walls can be overcome by a) 0.001 to 0.005 b) 0.001 to 0.005
c) 0.001 to 0.05 d) 0.01 to 0.005 CO2 BTL1 23 Research phase of technology development involves a) Design of procedure b) Selection of excipients
c) Identification of excipients d) All of the above CO2 BTL1 24 Easy handling order system a) LIFO b) FIFO
c) Above both d) None of the above CO2 BTL1 25 Price charged for a technology depends upon a) Technology b) High profit
c) Research cost d) market force

first give me answer for all these unit 2c questions

b) Inter company transfer

d) All of the above

d) All of the above

d) All of these

c) The collection and analysis of highly specific efficacy end point data

c) Novelty of the active ingredient and clinical improvement

d) Quality and safety for their product and services

c) Sampling, specification, testing, documentation and release procedures

a) Chief medical officer and clinical research associates

URS stands for? a) User Requirement Specification b) User Resource Specification c) User Retrospective Specification d) User Reference Specification CO3 BTL1 2 The variable for FBD control parameters includes a) Air volume b) Bowl change c) Bowl sieve
d) Porosity of the filter bags CO3 BTL1 3 Which of the following is used for validation of hot air oven? a) Voltmeter b) Pressure gauge c) Flow meter d) Stopwatch CO3 BTL1 4 Which of the following is an important aspect of equipment validation? a) Instrument Qualification b) Process Qualification c) Performance Qualification d) Validation Qualification CO3 BTL1 Q.No Question with Options CO BTL 5 Distance between two dies of a compression machine is checked with the help of? a) Optical micrometer b) Screw gauge c) Vernier caliper d) Monsanto tester CO3 BTL1 6 Performance Qualification checklist for compression machine is checked with the help of a) Punch shape b) Disintegration time c) Drug solubility d) Air velocity CO3 BTL1 7 The lowest available capsule size is a)0 b) 000 c) 1 d) 5 CO3 BTL1 8 Equipment validation must be always done by? a) User b) Vendor c) Manufacturer d) Dealer CO3 BTL1 9 cGMP stands for? CO3 BTL1 Q.No Question with Options CO BTL a)Compendium Good Manufacturing Practices b) Compendium Good Monitoring Practices c) Current Good Manufacturing Practices d) Current Good Monitoring Practices 10 Regulatory basis of process validation is available in: a) FDA b) USP c) IP d) BP CO3 BTL1

ans..with question an options