INTRO 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)

Qualitative

Quantitative

Pharmaceutical Analysis 2 divisions

Qualitative

• identification of components in a given sample

• identity of the chemical species present in the sample

Qualitative

• Quality or character of chemical

• determination composition of chemical

Quantitative

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

Quantitative

Answers the question: “How much is present in the sample?”

Qualitative

Answers the question: “What is present in a given sample?”

identity of the drug in the formulated product

determination of active ingredient or additional impurities

stability of the drug

rate of the drug from its formulation

identity and purity of pure drug that meets specification concentrations of specified impurities

concentrations of drug in plasma or biological fluids

determine pKa values, partition coefficients, and solubilities(physicochemical properties)

stability of drug under development

Importance of Pharmaceutical Analysis

Quality

• Degree of excellence

• 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)

Quality

Excellence that is better than a minimum standard.

Drug Quality in the World

Availability of substandard and counterfeit drugs in disturbing proportion in many low- income countries

Drug Quality in the World

Lack of reliable drug quality assurance systems in many developing countries

Quality Control

sum of all tests performed to determine the conformance of the product to specification

Quality Control

Guarantees that the product:

o Is free of impurities

o Physically and chemically stable

o Contains the amount of active ingredients as stated in the label

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

Quality Assurance

Over-all organizational body designed to assure product quality.

Quality Assurance

Sum of all processes performed to ensure that the productpossess all the characteristics it is intended to have.

cGMP, AO 43, WHO guidelines, ISO, EU

All manufacturing activities of a laboratory are based on?

Current Good Manufacturing Practices

regulations: force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective

GMP

regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.

Current Good Manufacturing Practices

protects the consumer from purchasing aproduct which is not effective or even dangerous.

Current Good Manufacturing Practices

Benefits

• Eliminates the risk of marketing unsafe product.

• Guarantees conformance to regulatory requirement

• Guarantees product efficacy

• Reduces operating cost

• Reduces operating loses

• Produces higher employee morale

• Motivates health care professional to sell or prescribed the product

Quality Responsibility

Quality is the collective responsibility of every Quality Responsibilityindividual in an organization.

Quality by Design (QbD Approach)

• Quality is not an add-on

• Product quality criteria must be established.

• Detailed specifications provide quantitative parameters for measurement.

Quality by Design (QbD Approach)

• Written procedures document how quality is attained and maintained

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

ORGANIZATION OF QUALITY CONTROL

material inspection section

analytical laboratory

biological testing laboratory

specifications & analytical development

quality coordinating office

Materials Inspection Section

• To sample and examine all raw materials received

Materials Inspection Section

• 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.

Analytical Laboratory

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.

Biological Testing Laboratory

To conduct environmental monitoring.

Specifications and Analytical Development

To coordinate with research, product development, production sales and management towards improvement of a product.

Specifications and Analytical Development

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. These records include the batch and master formula records, raw material analytical records, printed and packaging material inspection reports and retention files.

Quality Coordination Office

To maintain and develop SOP’s.

Based on Sample Size

Based on Extent of Determination

Based on Nature of Methods

TYPES OF ANALYSIS