QUALITY ASSURANCE AND QUALITY CONTROL OF PHARMACEUTICALS

Quality

Totality of characteristics of features of a product that bears on its capacity to satisfy stated or implied needs.

Identity

Purity

Strength

Safety

Performance

Packaging

Labeling

QUALITY OF PHARMACEUTICALS

• A medicine quality can be evaluated through the following characteristics:

Identity (Appearance)

QUALITY OF PHARMACEUTICALS

Important to its efficacy and purity.

Purity

QUALITY OF PHARMACEUTICALS

To know if the product will provide its effectiveness and without any impurities..

Strength

QUALITY OF PHARMACEUTICALS

The amount that should be present on a drug product.

Performance

QUALITY OF PHARMACEUTICALS

Products should also perform their intended functions.

Ex: Enteric Coated

Gastric- should be intact

Intestinal- should dissolved within few minutes

Packaging and labeling

QUALITY OF PHARMACEUTICALS

Responsible for holding and protecting the product as well as the packaging materials.

-Quality management

-Quality assurance

-cGMP

-Quality control

QUALITY RELATIONSHIPS

- It is important to have a harmonized system within a manufacturing company to ensure that each unit has responsibility.

- When creating a product it requires collaboration between different personnels from different persons.

Quality Relationship: the driving units to produce a quality product

Quality Management

Coordinates activities to direct and control an organization with regard to quality.

Note:

-Oversee the quality of the product during the production.

- Create continuous improvement. (Conduct audits where we can see variations in terms of processes and quality. They will find a way to correct it to ensure the company can still continue to work.

- Audits should be done regularly

- Will set all protocols on how to fulfill the desired goal.

-Customer focus

-Leadership

-Engagement of people

-Process approach

-Continuous improvement

-Evidence based approach

-Relationship approach

Enumerate the principles of quality management

Good Manufacturing Practice (GMP)

To ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use.

Current Good Manufacturing Practice (cGMP)

requiring companies to use technologies and systems that are up-to-date in order to comply with current regulations.

Administrative Order No. 220,s.1974

Philippines Department of Health establishes guidelines for good manufacturing practices for drugs.

“intended use”

The goal of having cGMP is to make sure the product is for?

1. Quality System

2. Organization and Personnel

3. Building and Facilities

4. Equipment

5. Documentation

6. Production

7. Packaging and Identification

8. Storage and Distributions

9. Validation

10. Returned and Salvaged Products

Enumerate the Manufacturing Operational Requirements

1. Minimizes or eliminates the risk of marketing unsafe products

2. Guarantees conformance to regulatory requirements

3. Guarantees product efficacy

4. Reduces operating costs and operating losses

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

WHAT ARE THE POTENTIAL BENEFITS OF CGMP?

Quality Assurance

-The sum of the organized arrangements of processes made with the objective of ensuring the quality products are consistently produced in their intended use.

-Develop or creates process that should be followed, includes protocols for quality control units

Process Oriented

QUALITY ASSURANCE

Focuses on creating and improving processes to ensure consistent and high-quality outputs.

Defect Prevention

QUALITY ASSURANCE

By planning and optimizing processes effectively, QA minimizes the chances of defects occurring.

Proactive Approach

QUALITY ASSURANCE

QA emphasizes planning and acting in advance to avoid potential issues.

RESPONSIBILITIES OF QUALITY ASSURANCE

1. Identify and prepare necessary policies and SOPs relative to the control of the quality

2. Determine if these SOPs and policies are current and correct

3. Ensures that these policies are strictly followed

4. Final authority for product acceptance/ release and rejection
Note: Qc runs the tests, but the final say of acceptance and decision after reviewing the product is QUALITY ASSURANCE.

5. Serves as the primary contact with regulatory agencies (such as FDA)

6. Responsible for quality monitoring and audits

7. Give the company inside reports on its level of compliance
Note: Provides recommendations on which actions are needed to take wether preventive or reactive reactions

Quality Control

The part of cGMP that is concerned with sampling, specifications and testing, and ensures that the relevant and necessary tests are intact and in fact carried out and that the products are not released for sale until their quality has been adjudged to be satisfactory.

• Product

• Oriented

• Defect Detection

• Reactive Approach: QC takes action only after examining the product and identifying issues or their causes.

Note: Focused on product testing and analysis. To ensure that the products meet certain specifications and defects.

RESPONSIBILITIES OF QUALITY CONTROL

● Sampling and analytical testing of incoming raw materials and finished products.

● Inspection of packaging components including labelling.

● Conduct in-process testing.

● Perform environmental monitoring.
Note: The conditions in the working station (e.g., temperature)

● Inspect testing operation for compliance.

● Test product complaints and/or samples.

● Evaluate production stability.
Note: The characteristics and properties of the drug are maintained (in harsh environments).

Organizational Charts

To give us the idea of the important units. Can be different in any company.

Example: (Flow Chart)

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.

Note:

- Describes specific raw material or finished product. Recommend test that should be conducted on certain products to know its properties as well as packaging and labelling.

Acceptance Criteria: Specification

Pharmacopeia: Book of Standards (are intended to be imported, manufactured on a specific region)

Certificate of Analysis (COA)

● A document containing the results of all tests conducted on a specific material to show compliance

Should also contain:

-Name/ Address

-Lot or Batch Number

-Date of Manufactured

Standard Operating Procedure (SOP)

● A written instruction that documents the proper sequence of steps to be done.
Example: SOP on instrument operation

SOP CONTAINS:
● Purpose
● Scope
● Responsibility
● Procedure
● Changed history
● Safety measures
● Material and equipment
● Reporting
● Reference Documents