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GMP Quality Control and Assurance Guide

The document outlines the basic principles of Good Manufacturing Practice (GMP), including ensuring consistent production and controlling risks. It defines requirements for GMP such as validated processes, appropriate facilities and equipment, trained personnel, complete records, and recall systems. The roles and responsibilities of quality control and quality assurance are also discussed.

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vijayns_250355172
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9 views11 pages

GMP Quality Control and Assurance Guide

The document outlines the basic principles of Good Manufacturing Practice (GMP), including ensuring consistent production and controlling risks. It defines requirements for GMP such as validated processes, appropriate facilities and equipment, trained personnel, complete records, and recall systems. The roles and responsibilities of quality control and quality assurance are also discussed.

Uploaded by

vijayns_250355172
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd

Basic Principles of GMP

Quality

Module 4

Slide 1 of 11

Quality
GMP

Ensure that products are consistently produced and


controlled

Diminishes risks that cannot be controlled by


testing of product
Cross-contamination
Mix-ups

Module 4

Slide 2 of 11

Quality
Basic Requirements for GMP
1)

Clearly defined and systematically reviewed processes

2)

Critical steps validated

3)

Appropriate resources: personnel, buildings, equipment,


materials

4)

Clearly written procedures (SOP, Master documents)

5)

Trained operators

6)

Complete records, failure investigations

7)

Proper storage and distribution

8)

Recall system

9)

Complaint handling

Module 4

Slide 3 of 11

Quality

Module 4

QC / QA is part of GMP

Slide 4 of 11

Quality
Quality Control (QC) Department

Independent from production and other


departments is considered to be fundamental

Under the authority of an appropriately qualified


and experienced person with one or several control
laboratories at his or her disposal.

Module 4

Slide 5 of 11

Quality
Basic Requirements for Quality Control
Resources

Adequate facilities

Trained personnel

Approved procedures (validated test methods)

Module 4

Slide 6 of 11

Quality
Basic Requirements for Quality Control
Responsibilities

Testing
Starting materials
Packaging materials
In-process
Bulk products
Finished products

Module 4

Environmental conditions

Monitoring

Releasing/rejecting of materials
Slide 7 of 11

Quality
Other Duties of the Quality Control
Department
1)

Establish QC procedures

2)

Reference standards availability

3)

Stability testing

4)

Complaint investigations

5)

Environmental monitoring

Module 4

Slide 8 of 11

Quality
Basic Requirements for Quality
Assurance
Resources

Trained personnel

Approved procedures

Module 4

Slide 9 of 11

Quality
Basic Requirements for Quality Assurance
1)

Sampling

2)

Records

3)

Review and evaluation of Production / QC documentation

4)

Failure investigations for all deviations / incidents

5)

Ingredients comply with the marketing authorization

6)

Ingredients are of the required purity / quality

7)

Proper containers

8)

Correct labelling

9)

Release of batches by the authorized person

10)

Retained samples of starting materials and products

11)

Any changes to written procedures, systems equipments should be


handled

Module 4

Slide 10 of 11

Quality
Assessment of Finished Products
Should embrace all relevant factors. For example:

production conditions

in-process test results

manufacturing documentation

compliance with finished product specification

examination of the finished pack

annual review of finished products

Module 4

Slide 11 of 11

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