"Quality Control" Pharm ana 12

Quality Assurance

is a broader concept that encompasses all aspects of the processes, procedures, and systems that assure quality in pharmaceutical manufacturing and operations

Systematic Approach

Process Validation

Training and Compliance

Risk Management

Focus on Processes

Quality Assurance

QualityControl

referstotheprocessof testing andinspectingproductstoensuretheymeettherequired specificationsandqualitystandards

Testing

Batch Release

In-Process Control

Documentation

Focus on Products

Quality Control

QUALITY

The totality of characteristics or features of a product that bear on its capacity to satisfy stated of implied needs.

QUALITY

Sum of all factors that contribute directly or in directly to the safety, effectiveness, acceptability, andreliability of the product.

QUALITY ASSURANCE and QUALITY CONTROL

Concepts of Quality

QUALITY ASSURANCE

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

QUALITY ASSURANCE

Sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required by their intended to have

QUALITY ASSURANCE

The responsibility of an organization to determine that systems facilities and written procedures are both adequate followed in the final dosage form, all the applicable specifications.

Quality Assurance

A managing tool

Quality Assurance

Process-oriented

Quality Assurance

Proactive strategy

Quality Assurance

Prevention of Defects

Everyone’s responsibility

Performed in parallel with a project

Quality Control

A corrective tool

Product-oriented

Reactive Strategy

Quality Control

Detection of defects

Quality Control

Testing team’s responsibility

Quality Control

Performed after the final product is ready

Total Quality Control

The organized effort within and entire establishment to design, procure, maintain and assure the specified quality in each unit of product distributed

Sampling

The process of removing an appropriate numberofitemsfromapopulationinorderto makeinferencestotheentirepopulation.

Testing

The accuratemeasurement of characteristic and included quantitative and qualitative examination at specified or random checkpoints

Final product, Raw materials, Intermediate products

Materials to be sampled include

Sampling

Selection of a portion of a batch.

Sampling

To represent the entire batch population.

Sampling

A sample chosen for further evaluation.

Sampling

Various sampling methods (random, systematic).

Sampling

Conducted before testing to select samples

Testing

Evaluation of a sample's properties/quality.

Testing

To determine compliance with specifications

Testing

Results indicating quality characteristics

Testing

Various testing methods (chemical, physical)

Testing

Conducted on the selected samples.

Inspection

Thetrained,accurateobservationthatusually involves thevisualmonitoringof an itemat specifiedorrandomcheckpoints.

Monograph

A document which specifies all the tests to be conducted on a particular material or product, the procedure and or appropriate references containing the details of the procedure and the expected results.

Chanced cause

Any unknown random cause which inevitable and cannot be predicted.

Certificate of Analysis

Adocumentcontainingtheresultsofall tests conducted on a specific material or non compliance with established standards or specifications approved by responsible personnel

Visual inspection in pharmaceuticals

s a critical quality control process that involves the careful examination of pharmaceutical products to ensure they meet established quality standards before they reach consumers

Quality Assurance, Regulatory Compliance, Product Integrity

key aspects of visual inspection in the pharmaceutical industry

Quality Assurance

in visual inspection, to confirm that the product is free from physical defects, contaminants, or other anomalies

Regulatory Compliance

in visual inspection, to ensure compliance with regulatory standards established by authorities like the FDA or EMA

Product Integrity

in visual inspection, to maintain the trust of healthcare professionals and patients by ensuring the product is safe and effective

monograph

a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA)

Identity

Test to identify that a particular substance is the medicine that it claims to be

Strength

Tetsing methods and acceptable ranges for the potency of medicine, as reflected in FDa’s approvals. for example, this indicates the amount of API in a medicine

Purity

Information on impurities that may be present in a medicine and the amounts that are permitted, along with the testing methods to identify and measure them.

Impurity

is any component in the API or finished dosage form which is not the desired product or other formulation components. Levels that exceed may be present patient safety concerns

Performance

Laboratory tests to predict and demonstrate how a medicine will be released as it enters the body

QUALITY CONTROL

Provides assurance that products will be consistently of qualityappropriatetotheirintendeduse.

QUALITY CONTROL

Assured that all quality control arrangement are in place and infact carried out.

QUALITY CONTROL DEPARTMENT

Ensures uniform production of high quality product

QUALITY CONTROL DEPARTMENT

Safeguards public health

QUALITY CONTROL DEPARTMENT

Ensures that the minimum standards of the product comply with BFAD requirements

Analytic testing

laboratory-Research and Development Department

Biological Test

QUALITY CONTROL MANAGEMENT sections

Packaging

IdentityTest

Limit Test

Potency Test

Dosage-form Specific Test

Quality Control General Test Classification

Material Type

Special properties

Integrity

Packaging

Transparent, collapsible, easy to drain

Special properties in packaging

Tightness, leak-free

Integrity in packaging

Physical method

Physical Properties

Chemical Method

Identity Test

Specific Gravity, Refractive Index, Optical rotations.

Physical method in Identity test

Gross physical appearance, like color, odor, consistency, dimensions

Physical Properties in Identity test

Visible chemical reactions

Chemical Method in Identity test

Gross dirt, insoluble matter

Gross Impurities in Limit Test

trace metals ions, degradation products

Chemical Impurities in Limit Test

viable microorganisms (aerobic/anaerobic)

Biological Impurities in Limit Test

Instrumental method

Chemical method

Biological method

Potency Test

HPLC, UV spectrometry, Polarimeter, Gas Chromatography

Instrumental method in Potency Test

Titrimetric

Chemical method in Potency Test

Live animals, excised animal organs or tissues, biological products (enzymes and proteins), microorganism

Biological method in Potency Test

Tablets and Capsules

Implants

Parenteral

Sample

Turmeric Paper

Dosage Form Specific Test

Tablets and Capsules

dissolution, disintegration

Implants

disintegration

Sample

taken from a population

Sample

should represent the whole batch from where it is taken.

Sample

is a finite number of objects selected from a population

Turmeric paper

detects borate