Pharmaceutical Classifications

Chapter: Quality Assurance

Types of Specifications: 4 types

1. Identity

2. Quality

3. Purity

4. Potency

* Parameters of Quality analysis

1. Specificity

2. Sensitivity

3. Linearity

4. Precision

5. Accuracy

6. Ruggedness

6. System suitability

* Division of Validation- 4 divisions

1. Cleaning validation

2. Process validation

3. Analytical method validation

4. Computer system validation

* Validation Phases- 3 phases

Phase-1: Pre-validation phase (Qualification phase)

Phase 2: Process validation phase (Process qualification phase)

Phase 3: Validation maintenace phase

* Validation of Pharmaceutical Equipments (Types of Qualification)

1. Design qualification (DG)

2. Installation Qualification (IQ)

3. Operational qualification (OQ)

4. Performance qualification (PQ)

Types of Process validation-4 types

1. Prospective validation (Development stage)

2. Concurrent validation (Production stage)

3. Retrospective validation (Examination of past experience of production)

4. Revalidation

* Stages of Process validation–3 stages

1. Process design

2. Process Qualification

3. Continued process Verification

* Parameters of method validation

1. Specificity

2. Sensitivity

3. Linearity

4. Precision

5. Accuracy & Recovery

6. Ruggedness

6. System suitability

* Phases of Water system qualification–3 phases

Phase 1: Investigation

Phase 2: Verification

Phase 3: Long term control

* Types of Compression machine tooling

1. D tooling (Tablet size 25 mm)

2. DB tooling (Tablet size 19 mm)

3. B tooling (Tablet size 16 mm)

4. BB tooling (Tablet size 13 mm)

IPC Check during Dispensing

⇨ Room Condition (RH, Temperature)

⇨ Apperance

⇨ Contamination during weighing

⇨ Weighing of incorrect material, wrong material

* IPC Check during Granulation

⇨ Time & Speed

⇨ Homogenicity

⇨ Granular size

⇨ Moisture of granules

IPC Check during Tableting

⇨ Room Condition (RH, Temperature)

⇨ Machine speed

⇨ Compression pressure

⇨ Appearance

⇨ Thickness

⇨ Hardness

⇨ Friability

⇨ Disintegration time

⇨ Moisture content

⇨ Diameter

⇨ Weight

⇨ Relative Standard Deviation–RSD (Used to determine if the standard deviation of a set of data is small or large when compared to the mean deviation)

IPC Check during Coating

⇨ Room Condition (RH, Temperature)

⇨ Apperance

⇨ Time and Speed

⇨ Disintegration time

⇨ Dissolution time

⇨ Percentage of weight gain

⇨ Mosture content

IPC Check during Capsule filling

⇨ Room Condition (RH, Temperature)

⇨ Apperance

⇨ Machine Speed

⇨ Weight

⇨ Disintegration time

⇨ Moisture content of pellets

IPC Check during Oral liquid filling & sealing

⇨ Appearance

⇨ Machine speed

⇨ pH

⇨ Leakage test

⇨ Volume check

⇨ Sealimg of bottle

IPC Check during Injectable Product filling & sealing

⇨ Room Condition (RH, Temperature)

⇨ Appearance

⇨ Weight (Average & Uniformity)

⇨ Clarity test (Ensure that the parenterals are free from the visible foreign particles)

⇨ Leakage test

⇨ Volume check

IPC check during Primary packaging

⇨ Machine speed

⇨ Batch number

⇨ Manufacturing date

⇨ Expiry date

⇨ Leak test

⇨ Sealing

⇨ Batch printing

⇨ Batch number

⇨ Manufacturing date

⇨ Expiry date

⇨ Price

⇨ Quantity

ICH guidelines

Q1: Stability

Q2: Analytical Validation

Q3: Impurities

Q4: Pharmacopoeias

Q5: Quality of Biotechnological Products

Q6: Specifications

Q7: Good Manufacturing Practices

Q8: Pharmaceutical Development

Q9: Quality Risk Management

Q10: Pharmaceutical Quality System

Q11: Development & Manufacture of Drug Substances

Q12: Lifecycle Management

Clauses of ISO 9001:2015

⇨ Leadership

⇨ Planning

⇨ Support

⇨ Operation

⇨ Performance evaluation

⇨ Improvement

* The 10 Golden Rules of GMP

1. Get the facility design right from the start

2. Validate processes /সমস্ত Process গুলোকে Validate করা

3. Write procedures and follow them

4. Identify who does what

5. Keep good records

6. Train and develop staff

7. Practice good hygiene / Good hygiene practice করা

8. Maintain facilities and equipment/ Facilities এবং Equipment গুলো Maintain করা

9. Build quality into the whole product lifecycle

10. Performing regular audit/ Regular Audit Perform করা

* Points to be followed for IPC more effective

⇨ People

⇨ Training

⇨ Environment

⇨ Process

⇨ Equipment

⇨ Management

Criteria for quality

⇨ Safety

⇨ Potency

⇨ Efficacy

⇨ Stability

⇨ Acceptability

⇨ Regulatory Compliance

* Five basic points for quality

⇨ Safety

⇨ Quality

⇨ Identity

⇨ Potency

⇨ Purity

* Types of Calibration

1. Internal calibration

2. External calibration

* Information included in Dossier

⇨ Company Information

⇨ Master formula of a product

⇨ Manufacturing procedure

⇨ Manufacturing equipments list

⇨ Stability data

⇨ Preclinical & Clinical data

⇨ Specification

⇨ Other related documents

Information should be included in Master formula Used in Manufacturing

⇨ Product name

⇨ Product description

⇨ Strength of the product

⇨ Batch size

⇨ Quantities of ingredients

⇨ Specification of each ingredients

⇨ Manufacturing instruction

⇨ Control instruction

⇨ Detailed description of Packaging information

Information should be included in BMR  relating to Batch & Product

Product name

Batch number

Date

Responsible person name

Quantity

Quality control report

In-process control information

details of any deviation

Information should be included in BMR  (relating to packaging instruction)

Product name

Batch number

Code number

Batch formula & brief packaging process

Packaging date

Theotretical & actual yield

Records of cleaning of equipment

In-process control & laboratory result

Packaging line clearance record

Manufacturing & Exipry date

Chapter: Pharmaceutical Mixing

Types of Granulation-2 types

1. Wet Granulation

2. Dry Granulation

Steps of wet granulation of tablet-13 steps

1. Requisition of raw material

2. Weighing & Dispensing

3. Crushing & Sieving of all ingredients

4. Dry mixing in the Rapid mixer granulator

5. Addition of binder solution

6. Wet mixing

7. Co-milling

8. Drying in Flyidized Bed Dryer (Granule creating)

9. Dry milling/ Size reductiom

10. Lubrication/ Glidant added

11. Compression of tablet

Equipments for wet granulation

⇨ Fluidized bed granulator

⇨ High Shear mixer

⇨ Sigma blade

⇨ Heavy duty planetary mixer

⇨ Tumble blender

Steps of Dry granulation of tablet

1. Requisition of raw materials

2. Weighing

3. Dispensing

4. Compression into slugs/ Roll compaction

5. Milling & Screening of slugs

6. Lubrication / Blending (Mixture of two or more things)

7. Compression of tablet

Equipments for particle size reduction

⇨ Oscillating granulator

⇨ Hammer mill

⇨ Mechanical sieving device

⇨ Screening device

Factors consideration during oven drying operation

⇨  Air flow

⇨ Air Temperature

⇨ The depth of the granulation tablet

Factors consideration during Scale-up drying process

⇨ Rate of air flow

⇨ Inlet air flow

⇨ Humidity

Problems identification during pilot plant scale up of tablet compression

⇨ Capping

⇨ Sticking to the punch surface

⇨ Tablet hardness

⇨ Weight variation

Drying Equipments

⇨ Hot air Oven

⇨ Fluidized bed dryer

Steps of Spheronization

1. Dry mixing

2. Wet massing

3. Extrusion

4. Spheronization (Spheronization is the process where extrudates are shaped into small rounded or sperical granules)

5. Drying

6. Screening

7. Lubrication

8. Tablet compression

Types of Voids

1. Open intraparticulate voids

2. Closed intraparticulate voids

3. Interparticulate voids

Types of forces affecting flow properties of solids

1. Cohesive forces or Van der Waals forces

2. Electrostatic forces

3. Frictional forces

4. Mechanical forces

5. Surface tension forces

Basic Components of Compression machine

Hopper

Die

Punch

Cam Track

Feeding mechanism

Compression factors affecting particle size distribution

⇨ Flowability

⇨ Compressibility (Compressibility is a measure of the relative volume change of a solid or a fluid in response to a pressure change)

⇨ Uniformity of Tablet weight

⇨ Content Uniformity

⇨ Tablet hardness

⇨ Color uniformity of tablet

Types of Tablet Coating

1.Sugar Coating

2. Film Coating

Types of Film coating

1. Non-enteric film coating

2. Enteric film coating

Classification of dissolution apparatus (USP)

Apparatus 1: Rotating Basket

Apparatus 2: Paddle Assembly (most widely used)

Apparatus 3: Reciprocating cylinder

Apparatus 4: Flow through cell.

Apparatus 5: Paddle over disk

Apparatus 6: Cylinder

Apparatus 7: Reciprocating holder

Reciprocating Cylinder

Dissolution test stages with acceptable range

Stage 1 // 6 tablets ⇨ dissolved amount of each unit should not less than D+5%

Stage 2// 12 tablets ⇨ Average 12 units is eual to or greater than D and no unit is less than D-15%

Stage 3// 24 tablets ⇨ Average of 24 units is equal to or greater than D, not more than 2 units are less than D-15% and no unit is less than D-25%

[D= Dissolved active ingredient specified in the  individual monograph)

Chapter: Pharmaceutical Instruments

Classification of HPLC

⇨ Normal Phase Chromatography

⇨ Reverse Phase Chromatography

⇨ Adsorption Chromatography

⇨ Ion Exchange Chromatography

⇨ Partition Chromatography

⇨ Size Exclution Chromatography

⇨ Isocratic Separation Chromatography

⇨ Gradient Separation Chromatography

⇨ Analytical HPLC

⇨ Preparative HPLC

⇨ Qualitative Analysis HPLC

⇨ Quantitative Analysis HPLC

Types of Chromatography

⇨ Affinity Chromatography

⇨ Pseudo-affinity Chromatography

⇨ Column Chromatography

⇨ Dye-ligand Chromatography

⇨ Gas Chromatography

⇨ Gel-Permeation Chromatography

⇨ High Performance Liquid Chromatography (HPLC)

⇨ Hydro-interactive chromatography

⇨ Paper Chromatography

⇨ Thin Layer Chromatography

Classification of Potentiometric titration

⇨ Acid-Base Titration

⇨ Oxidation-reduction titration

⇨ Precipitation titration

⇨ Back Titration

In acid base titration acid whose strength is to be determined is take place in the conical flax and alkai is placed to the burette.

Types of Spectroscopy

⇨ UV visible Spectroscopy

⇨ IR spectroscopy

⇨ NMR Spectroscopy

⇨ Mass Spectroscopy

Chapter: Microbiology

Sterilization Processes

A. Physical Processes of Sterilization

1. Thermal sterilization method

i. Dry heat Sterilization

ii. Moist heat sterilization

iii. Fractional Sterilization

iv. Marginal Sterilization

2. Non-Thermal Sterilization methods (Cold Sterilization)

2.1 Physical methods

2.1.1. Filtration method

2.1.2. Radiation method

2.1.2.A. Non-ionizing sterilization (Ultraviolet radiation)

2.1.2.B. Ionizing sterilization (Gamma ray, B ray, Cathode ray)

2.2. Chemical sterilization methods

2.2.1. Gas Sterilization (Ethylene oxide, beta propiolactone, hydrogen peroxide)

New technologies of Sterilization

1. Ultra high pressure

2. High-intensity light pulse

3. Gas plasma

Types of Culture media

1. Nutrient media

2. Differential media

3. Minimal media

4. Selective media

5. Transport media

6. Enriched media

Classification of Fungi-4 taxonomic classes

1. Zygomycetes

2. Ascomycetes

3. Deuteromycetes

4. Basidomycetes

Morphological Classification of Fungi- 5 morphological briad groups

1. Yeasts

2. Yeast-like fungi

3. Dimorphic fungi

4. Filamentus fungi

5. Mushrooms and toadstools

Classification antibioltic assays:

1. Conventional

2. Enzyme-based & immunoassays

3. Biological assay

Types of Pyrogen test

1. Rabbit test

2. LAL test

Types of Bacteria

1. Gram positive Bacteria

2. Gram negative Bacteria

Chapter: Research & Development

Methods of Stability Study

1. Real time/ Long term stability study

2. Intermediate stability study

3. Accelerated stability study

7 Stages of New product Development

1. Idea generation

2. Idea screening

3. Concept development and testing

4. Marketing strategy and business analysis

5. Product development

6. Test marketing

7. Product launch

Drug development process according to FDA

1. Discovery and development

2. Preclinical Research

3. Clinical Research

4. FDA Review

5.FDA post market safety monitoring

Critical Process Parameters in drug development

⇨ pH

⇨ Disintegration time

⇨ Dissolution time

⇨ Impurities

⇨ Water content

⇨ Dose accuracy

⇨ Dissolved Oxygen

⇨ Oxidation-reduction potential

RMR (Raw material requisition)