QUALITY MANAGEMENT

GMP FOR PHARMACEUTICAL PRODUCT (CPOB)

Modul-4
GMP RESOURCES
Wayan Redja
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2020
 GMP RESOURCES

PERSONNEL
PREMISES AND FACILITIES
EQUIPMENT
MATERIAL
DOCUMENTATION

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 C. GMP RESOURCES

2. Personnel
a. Principle
> Availability of adequate number of qualified
personnel understand written responsibility.

> Each personnel must understand GM principle

including hygiene instruction through initial and
continual training related to his/he job.
.

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 C. GMP RESOURCES
2. Personnel (continuation)
b. Organization Structure

Plant
Manager Plant
Manager
Production Quality PPIC Technical
Manager Manager Manager Manager QA
Manager
QA QC
Manager Manager
PPIC Production QC Technical
Manager Manager Manager Manager

Model A Model B
 B. GMP RESOURCES

2. Personnel
c. Job Description, Authority and
Responsibility
> Responsible person specific job, authority and
responsibility must be mentioned in the written job
description.
> No gap or overlapping of responsibility

d, Key Personnel
> QA, QC, and Production Managers
> Full time registered pharmacist
> Experience at least 5 years

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 B. GMP RESOURCES
2. Personnel
d. Key Personnel

Table 1: Key Personnel Job Description

1. QA QC Prod
1. Assure Quality System implementation ■
2. Products are produced and stored as SOP ■
3. Assure the required test has been carried out ■
 B. GMP RESOURCES

Resources
3. Premises and Facilities
a. Principle
b. General
c. Weighing Area
d. Production Area
e. Cleanliness Room Qualification
f. Storage Area
g. QC Area
h. Supporting Facilities
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 B. GMP RESOURCES

Resources
3. Premises and Facilities
i. Critical Supporting Facilities
1). AHU
- Principle
- Type
- Component Function
- Operational Principle
- Room Classes
2) Water Treatment
- Principle, -Method, -Pure water spec.
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 B. GMP RESOURCES

B. Resources
3. Premises and Facilities
i. Critical Supporting Facilities
2) Water Treatment
- Principle
- Water Purification Methods
- Types of Purified Water
- Quality Control
3) Compressed gas

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 B. GMP RESOURCES

Resources
4. Equipment
a. Principle
b. Design and Construction
c. Installation
d. Maintenance

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 B. GMP RESOURCES

5. Documentation
a. Principle
b. General
c. Type of Documents
- Specifications
- Master Production Document
- Master Processing Procedure
- Master Packaging Procedure
- Batch Processing Record
- Batch Packaging Record
- SOP
- Records and Reports

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 ASSIGNMENT
1. What is GMP resources?
2. What must be carried out to assure the resources are valid.
3. Why resources are needed?
4. Why valid resources must be used in GMP?
5, How to prove that the machine we will use is valid?
6. What are GMP requirements of the machines?
7, What are GMP requirements of production building?
8. Why human resource is the most important resource in GMP?
9. Compare in a table the requirements and the main job and functions
of QA, QC and Production Manager?
10 Draw an organization structure of a pharmaceutical plant.

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THANK YOU

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