QUALITY MANAGEMENT SYSTEM

CONCEPTS UNDER QUALITY MANAGEMENT SYSTEM

1. Quality Management

2. Quality Assurance (QA)

3. Good Manufacturing Practice (GMP)

4. Quality Control (QC)

5. Quality in Pharmaceuticals

6. Benefits From A Quality Control System

QUALITY MANAGEMENT

• refers to  

• all activities and functions involved in the determination and achievement of quality policy, quality objectives, and responsibilities within an organization.

QUALITY MANAGEMENT

• ensures that

• all processes, systems, and outputs consistently meet predefined quality standards.

Quality Policy

A formal statement by top management expressing the organization's commitment to quality.

Quality Policy

• It serves as

• a guiding principle for all employees.

  • essential since companies have many SOPs to follow

  • should inspire employees and remind them that their work contributes to producing safe, high-quality products, protecting  both consumers and the company. 

Basic Elements of Quality Management

• Quality Planning

• Quality Assurance (QA)

• Quality Control (QC)

• An appropriate infrastructure or quality system

Quality Planning

establishing objectives and processes necessary to deliver results.

Quality Assurance (QA)

systematic activities ensuring quality requirements are met.

Quality Control (QC)

operational techniques to verify product quality.

An appropriate infrastructure or quality system

organized framework that ensures pharmaceutical products are consistently produced and controlled according to quality standards.

An appropriate infrastructure or quality system

• encompasses the

• organizational structure, procedures, processes, and resources needed to implement and maintain an effective Quality Management System (QMS).

QUALITY ASSURANCE (QA)

A proactive, process-oriented system that ensures quality is built into the product from development through production.

Key Functions of QA

1. Development and implementation of Standard Operating Procedures (SOPs

2. Validation of manufacturing processes and equipment

3. Training personnel on GMP 

4. Internal auditing and documentation control

5. Complaint handling and deviation management

QUALITY ASSURANCE (QA)

goal

"Prevention of defects."

GOOD MANUFACTURING PRACTICE (GMP)

ensures that products are consistently produced and controlled according to quality standards appropriate for their intended use and as required by the marketing authorization

Basic GMP Principles

1. Qualified and trained personnel

2. Approved and documented procedures (SOPs)

3. Controlled manufacturing environments (e.g. environment and humidity) 

4. Proper maintenance and calibration of equipment 

5. In-process and final product control

6. Proper documentation and record keeping

QUALITY CONTROL (QC)

A reactive, product-oriented system focused on identifying defects in the finished product. It is not enough to focus only on the process; the final product must also undergo quality control.

QUALITY CONTROL (QC)

• sum of all procedures undertaken to

• ensure the identity and purity of a particular pharmaceutical tool which gives the assurance that a product conforms to standards and specifications through a system of inspection, analysis, and action

QUALITY CONTROL (QC)

• can have no effect on the

• quality of the product

QUALITY CONTROL (QC)

activities 

• assay of API, dissolution testing, disintegration rate, tablet hardness, friability, presence of particles in a solution, etc.; using either 100% sampling or a computed sample size that represents the entire population

Functions of QC

1. Sampling, testing, and approval / rejection of raw materials, intermediates (impurities), and final products

2. Stability testing (determine shelf-life) and documentation

3. Environmental monitoring

QC Analyst

Conducts tests and records results

QC Supervisor

Reviews and approves test results

QA Department

Audits and verifies QC documentation

Production Head

implements corrective actions

Management

Ensures compliance and resources

Potential Benefits of an Effective QC System

1. Ensures product safety and efficacy

2. Reduces recalls and complaints

3. Improves manufacturing consistency

4. Builds regulatory and consumer confidence

QUALITY IN PHARMACEUTICALS 

• Quality refers to the

• suitability of a drug substance or drug product for its intended use

QUALITY IN PHARMACEUTICALS 

A pharmaceutical product must

consistently meet its identity, strength, purity, and safety requirements to ensure therapeutic efficacy and patient safety.

DEFINITION FROM WHO

• “Quality of a pharmaceutical product is the degree to which it meets the requirements of identity, strength, purity, and other characteristics designed to ensure safety and effectiveness”.

COMBINATION OF ATTRIBUTES

• The quality of a pharmaceutical product is determined by a combination of measurable attributes: identity, strength, purity 

• Together, these attributes-when compared to a standard- serve as the basis for measuring uniformity and acceptability of the product.

Measurable Criteria For Quality

1. Conformance

2. Fitness for Use

3. Reliability

4. Yield

5. Customer

CONFORMANCE

• The product must conform to specifications and limits set by pharmacopoeias (e.g. USP, BP, or local FDA standards) 

  • Considered defective if it is not met

CONFORMANCE

parameters

• appearance

• assay

• pH

• sterility,

• quantity,

• quality,

• correct API,

• correct excipient,

FITNESS FOR USE

• The product must perform its intended function effectively.

FITNESS FOR USE

parameters 

• ease of administration,

• correct dosage form, and

• bioavailability.

RELIABILITY

• The ability of a product to consistently perform its intended function throughout its shelf life.

RELIABILITY

ensures 

• stability,

• potency, and

• safety under prescribed storage conditions

YIELD

• Represents the proportion of acceptable units produced relative to total output.

YIELD

high yield

•  reflects efficient processes and minimal waste.

 CUSTOMER SATISFACTION

• The ultimate indicator of quality.

• Patients, physicians, and healthcare professionals must trust that the product is safe, effective, and consistent.

• Quality = Safe + Pure + Effective + Reliable

Higher Management

Main Areas Supervised

Entire organization

Higher Management

Key Responsibilities

Define quality policy, allocate resources, and regulatory compliance

Scientific VP

Main Areas Supervised

R&D, QC

Scientific VP

Key Responsibilities

Oversees product development, testing, validation, and batch release

R&D Department

Main Areas Supervised

Formulation, process dev’t

R&D Department

Key Responsibilities

Ensures new products meet standards before launch

QC Department

Main Areas Supervised

Laboratory testing

QC Department

Key Responsibilities

Conducts material and product testing, and prepares reports

Manufacturing VP

Main Areas Supervised

Purchasing, Production, Warehouse, Maintenance

Manufacturing VP
Key Responsibilities

Supervises operations, ensuring GMP compliance

Purchasing

Main Areas Supervised

Material sourcing

Purchasing

Key Responsibilities

Ensures suppliers and materials meet standards

Production

Main Areas Supervised

Manufacturing

Production

Key Responsibilities

Executes processes, maintains batch integrity

Warehouse

Main Areas Supervised

Storage and logistics

Warehouse

Key Responsibilities

Ensures proper handling and storage conditions

Maintenance
Main Areas Supervised

Equipment, facilities

Maintenance

Key Responsibilities

Prevents breakdowns affecting product quality

BENEFITS FROM A QUALITY CONTROL SYSTEM

1. The system minimizes or eliminates the risk of marketing unsafe products.

2. It guarantees conformance to regulatory requirements.

3. It guarantees product efficacy.

4. It reduces operating costs.

5. It reduces operating losses.

6. It produces higher employee morale.

7. It motivates the pharmaceutical/medical professions to sell or prescribe

SUMMARY OF MAIN CONCEPTS

Quality Control

• Focused on testing of the environment and facilities, the materials, components and product in accordance with the standard

• product; detetive

SUMMARY OF MAIN CONCEPTS

Good Manufacturing Practice

• Deals with risks that cannot be tested and builds quality into the product

• compliance; operational

SUMMARY OF MAIN CONCEPTS

Quality Assurance

• The unit that ensures the policy is achieved

• process; preventive

SUMMARY OF MAIN CONCEPTS

Quality Management

• Overall policy of the organization towards quality

• system-wide; strategic

COST OF QUALITY

• The total cost of ensuring that a product or service is of acceptable quality. 

• Used within a total quality management or performance improvement programme.

Prevention Costs

• Training, process design, validation

• Avoiding defects

• Associated with making sure that things will be done right

Prevention Costs

Example

• Training

• Employees

• Process design

• SOPs

• GMPs

• Validation of processes

Appraisal Costs

• Inspection, testing, auditing

• Measuring quality

• Associated if things were done correctly

Appraisal Costs

Example

• Testing

• Inspection

• Quality control

• Checking of drug product

Internal Failure Costs

• Scrap, rework, re-testing

• Defects before release

Internal Failure Costs

Example

• Rework

• Scrap

External Failure Costs

• Complaints, returns, recalls

• Defects after release

External Failure Costs

Example

• Recalls (Product)

• Complaints (Product)

SPECIFICATIONS AND STANDARDS

1. Specifications

2. Standards

3. ISO 9000

4. CAPA

SPECIFICATION

• A detailed written description of a material, product, or process to ensure compliance with quality standards.

SPECIFICATION

• list of 

tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described

• "Conformance to specifications" means that

• the drug substance and/or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

FORMULA (MASTER FORMULA RECORD)

A complete and precise description of the composition of the drug product

FORMULA (MASTER FORMULA RECORD)

includes

• Active Pharmaceutical Ingredient (API) quantity

• Excipients and their functions

• Overages (if any)

• Batch size

• Theoretical yield

FORMULA (MASTER FORMULA RECORD)

purpose 

• Ensures consistency and correct proportions in every batch manufactured

  • Every tablet, solution, vial, and ampoule has uniformity, and each of those units consistently exert the intended therapeutic use

RAW MATERIALS SPECIFICATION

• Standards describing the quality requirements for all ingredients used in manufacturing

RAW MATERIALS SPECIFICATION

includes

• Identity tests,

• purity and impurity limits,

• strength/assay,

• physical properties (e.g., moisture, particle size),

• microbial limits,

• safety data,

• approved suppliers

RAW MATERIALS SPECIFICATION

purpose 

Ensures all raw materials meet pharmacopoeial or internally validated standards before they can be used.

RAW MATERIALS SPECIFICATION

Example

API must meet USP, BP, or Ph.Eur. identity and assay specifications.

 STANDARD OPERATING PROCEDURE (SOP)

• A step-by-step written instruction defining how a specific operation must be performed.

 STANDARD OPERATING PROCEDURE (SOP)

Types Relevant to a Drug Product

• Manufacturing SOPs

• Cleaning SOPs

• Equipment operation SOPs

• Sampling and testing SOPs

• Packaging SOPs

• Job description of employees

• Every step, from receiving raw materials to their storage and testing

 STANDARD OPERATING PROCEDURE (SOP)

Purpose

• Provides uniformity, compliance, and reduces human error.

• Ensures that all processes are controlled and reproducible.

 FINISHED PRODUCT SPECIFICATIONS (FPS)

• A complete set of standards the final drug product must meet before batch release.

 FINISHED PRODUCT SPECIFICATIONS (FPS)

includes 

• Assay (API strength)

• Identity

• Dissolution/disintegration

• Content uniformity

• Impurities and degradants

• pH/viscosity (if applicable)

• Microbiological limits

• Appearance (color, shape, odor, clarity)

• Moisture content

• Packaging and labeling requirements

• Shelf-life and stability profile

 FINISHED PRODUCT SPECIFICATIONS (FPS)

purpose 

Ensures the drug is safe, effective, and consistent before reaching patients.

PACKAGING MATERIAL STANDARD

Specifications for all packaging components used to contain the drug product

PACKAGING MATERIAL STANDARD

Purpose

Ensures the packaging protects the drug from light, oxygen, moisture, contamination, and maintains stability throughout shelf life.

PACKAGING MATERIAL STANDARD

Testing Requirements

• Compatibility with the product

• Integrity and tightness

• Moisture and light protection

• Identification and print accuracy

• Compliance with pharmacopeial standards

PACKAGING MATERIAL STANDARD

includes 

• Bottles

• Blisters

• Caps

• Liners

• Labels

• Inserts

• Cartons

• Primary packaging (direct contact)

• Secondary packaging (protective)

TESTING METHODS (ANALYTICAL METHODS)

• Validated procedures for evaluating raw materials, in-process materials, and the final product.

TESTING METHODS (ANALYTICAL METHODS)

types of tests 

• Chemical analysis (HPLC, UV-Vis, GC)

• Physical tests (hardness, friability, dissolution)

• Microbiological tests (sterility, MLT, endotoxin)

• Stability testing methods

• Identity and purity testing

TESTING METHODS (ANALYTICAL METHODS)

purpose 

Ensures test results are accurate, precise, specific, and reproducible.

STANDARD

•  a document that provides requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose

• A benchmark or reference against which quality is measured. 

 PHARMACOPEIAL STANDARDS

• legally enforceable and used globally.

• Official quality requirements published in recognized pharmacopeias (official compendia)

PHARMACOPEIAL STANDARDS

examples 

• US -United States Pharmacopeia

• BP British-Pharmacopoeia

• Ph. Eur.-European Pharmacopoeia

• JP-Japanese Pharmacopoeia

• IP-Indian Pharmacopoeia

• Philippine PNF/PBP