Introduction to Pharmaceutical Analysis 2

Pharmaceutical Analysis

- Also known as Analytical Chemistry or Quantitative-Qualitative Chemistry

Pharmaceutical Analysis

Branch of chemistry that provides information relative to the composition of matter (chemical composition, structure, behavior)

1. Qualitative

2. Quantitative

Pharmaceutical Analysis has two major divisions:

Qualitative

Ixnvolves the identification of components in a given

sample

Qualitative

It gives the identity of the chemical species present in the sample

Qualitative

Quality or character of chemical

Qualitative

Determination composition of chemical

Qualitative

Ascertainment of impurities present in a given sample

Qualitative

Answers the question: "What is present in a given

sample?"

Quantitative

Involves the determination of the proportion/number of components in a given sample.

Quantitative

Testing is in terms of the chemical compounds, raw materials, and the proportioning of these things.

Test impurities

It has been a mandate that all pharma products and other drugs must comply with the standards to _______

Quantitative

Pharmaceutical Analysis reveals the categorization, identification, and determination of raw materials and final product outcomes.

Quality

- Degree of excellence

Quality

Sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability of the product

Quality

"Doing it right the first time and all the time".(TQM)

1. Strength

2. Quality

3. Purity

4. Packaging

5. Labelling

Poor quality drugs do not meet official standards for:

1. Availability of substandard and counterfeit drugs

2. Lack of reliable drug quality assurance systems

Drug Quality in the World

Quality Control (QC)

Is the sum of all tests performed to determine the

conformance of the product to specification

1. Is free of impurities

2. Physically and chemically stable

3. Contains the amount of active ingredients as stated in the label

4. Provides optimal release of active ingredients when the product is administered.

Quality Control (QC) guarantees that the product:

Quality Assurance (QA)

Over-all organizational body designed to assure product quality

Quality Assurance (QA)

Sum of all processes performed to ensure that the product possess all the characteristics it is intended to have

QC

- QC or QA (focus)

To identify defects in the finished products

QA

- QC or QA (focus)

To prevent defects with a focus process

QA

- QC or QA (goal)

To improve development and test processes so that defects do not arise

QC

- QC or QA (goal)

To identify defects after a products is developed and before it is released

QA

c- QC or QA (how)

Establish a good QMS and assessment of its adequacy with continuous monitoring

QC

- QC or QA (how)

Finding sources of quality problems to continually meet customer's requirement

QA

- QC or QA (what)

Prevention of quality problems through planned

and systematic activities

QC

- QC or QA (what)

- Analytical techniques used to maintain the product quality and process

QA

- QC or QA (responsibility)

- Everyone on the team

QC

- QC or QA (responsibility)

- Of a specific team that tests the product for defects

QA

- QC or QA (tool)

- managerial tool

QC

- QC or QA (tool)

- corrective tool

1. cGMP

2. AO 43

3. WHO guidelines

4. ISO

5. EU.

All manufacturing activities of a laboratory are

based on

Quality Responsibility

Is the collective responsibility of every individual in an organization.

Quality by Design (QbD Approach)

Product quality criteria must be established

Quality by Design (QbD Approach)

Detailed specifications provide quantitative parameters for measurement

Quality by Design (QbD Approach)

Written procedures document how quality is attained and maintained.

Quality by Design (QbD Approach)

Continuous monitoring to confirm quality is being built into the product.

1. material inspection section

2. analytical laboratory

3. biological testing laboratory

4. specifications & analytical development

5. quality coordinating office

Quality control manager

Materials Inspection Section

- To sample and examine all raw materials received

To sample and conduct physical tests on:

- All shipments of packaging materials.

- All manufacturing, filling, and packaging operations.

Analytical Laboratory

- To assure the acceptability of a product, it is

essential that all materials are within

specification.

- Tests are made not only to raw

materials and packaging components but also on

the bulk product during processing and after

packaging prior to its release to the market

Biological Testing Laboratory

- To perform and evaluate microbiological and pharmacological assays, sterility, pyrogen, and

bacteriological tests, irritation, safety, or acute

toxicity tests.

- To conduct environmental monitoring.

Specifications and Analytical Development

- To coordinate with research, product development,

production sales and management towards improvement

of a product.

- To establish specifications for raw and packaging

materials.

Specifications and Analytical Development

To validate existing and tentative procedures of testing.

• To establish specifications based on validated

procedures.

Quality Coordination Office

- To maintain and store records that represents the

history of the batch from start to finish. (batch and master formula records, raw material analytical records, printed and packaging material inspection reports and retention files)

- To maintain and develop SOP's.

Ultramicro

< 1 mg

Micro

1 - 10 mg

Semi-Micro

10 - 100 mg

Macro

100 - 1000 mg

1. Proximate analysis

2. Ultimate analysis

- Types of Analysis

- Based on Extent of Determination

Proximate analysis

- Types of Analysis

- Total amount of a class or group of active constituents

Ultimate analysis

- Types of Analysis

- Amount of a single chemical species in a sample.

1. Classical

2. Instrumental

3. Miscellaneous

- Types of Analysis

- Based on Nature of Methods

Classical

- Types of Analysis

- Titrimetric, Gravimetry

Instrumental

- Types of Analysis

- Spectrometry, Polarimetry

Miscellaneous

- Types of Analysis

- Water content, Ash content, Acid value, Iodine

value, etc.