GMP Equipments Requirements

Session 6: GMP Equipments Requirements

Total Session Time: 120 minutes

Pre-requisites

Learning Tasks

By the end of this session students are expected to be able to:

Resources Needed:

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

10 minutes Buzzing

2 General Features of Manufacturing Equipment

Presentation

Small group

3 35 minutes discussion GMP Requirements for Equipments

Presentation

4 20 Minutes Presentation Construction of Equipment

20 minutes Basic Equipment in Pharmaceutical

5 Presentation

Manufacturing

20 Minutes Calibration, Cleaning and Maintenance of

6 Presentation

Equipment

7 05 minutes Presentation Key Points

8 05 minutes Presentation Evaluation

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: General Features of Manufacturing Equipment (10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

be of appropriate design, adequate size, and suitably located to facilitate operations for its

intended use and for its cleaning and maintenance

by providing information on requirements and feedback on existing equipment

operations to be carried out

STEP 3: GMP Requirements for Equipments (35 minutes)

Activity: Small Group Discussion (10 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

ALLOW students to discuss for 10 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

o Operating criteria

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

 Should be adequate to meet process, size, speed and effectiveness requirements

o Spare parts

 Availability of spares and servicing

 This can result in using different makes of an equipment in different parts of the

world

o Maintenance

 Frequency and ease of maintenance significantly impact on productivity and even

quality

 Equipment break down during process could adversely affect quality

 Cleanability of the equipment

 Accessibility to the parts of equipment needed to be cleaned

 Easy of disassembling and re-assembling the equipment

o Environmental issues

 Dust dissemination

 Potential for contamination of other products and requiring operators to wear

additional protective clothing and frequent cleaning of facility

 Noise and energy use

o Equipment design, size and space required for its location

o Construction materials of the equipment

o Process controls on the equipment

 Automatic weight adjustment on tablet presses

 Temperature recorders on ovens

o Cost of the equipment

 Base price of the equipment

 Additional costs related to installation, etc.

o Design and maintenance manuals

 Manuals are important for validation/qualification of the equipment and

maintenance programs

STEP 4: Construction of Equipment (20 minutes)

cleaning and maintenance

o This will avoid cross-contamination, dust and dirt-build up and any adverse effect on

the quality of the product

o Surfaces

 Surfaces that contact components, in-process materials or drug product should be

smooth, nonreactive or absorptive

 These surfaces should not alter the safety, identity, strength, quality or purity of

the drug product beyond the official or other established requirements

o Fixed pipework (for transfer of materials through pipelines)

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

 All pipes used must be of right standard and specification for the material and

pipeline to prevent any wrong connections and mix-ups

 All pipes must be clearly labelled

 Labels in all pipes should indicate contents and direction of flow

 Servicing pipings and devices must be adequately marked

 The use of adaptors is not recommended

 Piping system should allow monitoring and testing of materials delivered in them

at regular intervals

o Substances required for operation of equipment

 Coolants, lubricants and other substances required for operation of the equipment

should not come into contact with components, drug product, containers,

closures, in-process materials or drug product

 Lubrication needs to be of good grade, controlled and monitored

o Potential sources of contamination

 Construction of equipment should be in a such a way that motors, drive belts,

gears and other potential sources of lubricant contamination are located away

from vessels or package openings that could result in product contamination

STEP 5: Basic Equipment in Pharmaceutical Manufacturing (20 minutes)

o Must be of appropriate range and precision

 All balances and measuring equipment must be capable of weighing or measuring

the materials over the desired range required for production and testing

 Appropriate weighing and measuring equipment must available in the relevant

areas i.e. production area and quality control laboratories

o Must be calibrated on scheduled basis

 Calibration must be done on regular intervals

 Check weighing must be done on daily basis

 Proper records of calibration must be maintained

o There are should be SOPs for use, calibration, cleaning and maintenance of weighing

and measuring equipment

o Must Production equipment must be suitably designed for the intended uses

o not be hazardous to the product

o Some production equipment include mixers, granulators, tablet presses, capsule filling

machine, liquid filling machine, packing machine etc

o Defective equipment must be removed or labelled to prevent use

o Must be designed to allow easy cleaning even if it is dedicated to one product

o Relevant SOPs (use, cleaning, maintenance) must be available and in use

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

o Equipment and instruments in quality control laboratories must be suitable for the

tests to be performed

o Defective equipment must be removed or labelled to prevent their use

o Equipment used for washing and drying should be designed to promote easy cleaning

 Cleaning on scheduled basis

 Procedures (SOPS) should be followed and records kept

STEP 6: Calibration, Cleaning and Maintenance of Equipment (20

minutes)

to prevent malfunctions or contamination

o Contamination alters safety, identity, strength, quality or purity of the drug product

beyond the official or other established requirements

o Control, weighing, measuring, monitoring and test equipment must calibrated

according to written SOP and an established schedule

o Performed using standards traceable to certified standards

o Calibration records maintained

o Current calibration status known and verifiable

o Out of calibration instruments should not be used, and deviations investigated to

determine if these could have had an impact on the quality of the intermediate(s) or

API(s) manufactured using this equipment since the last successful calibration

o There should be SOPs and schedules to be followed for cleaning and preventive

maintenance of equipment

o SOPs for cleaning of equipment and its subsequent release for use

o Detailed cleaning SOPs to enable operators to clean each type of equipment in a

reproducible and effective manner.

o The SOPs should include;

operations

 Methods for disassembling and reassembling equipment to ensure proper cleaning

and maintenance

equipment cleaning, when appropriate

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

o Records of calibration, cleaning and preventive maintenance of all equipment must

be kept properly

STEP 6: Key Points (5 minutes)

be of appropriate design, adequate size, and suitably located to facilitate operations for its

intended use and for its cleaning and maintenance

production equipment, quality laboratory equipment and equipment for washing, cleaning

and drying

STEP 7: Evaluation (5 minutes)

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

References

Signore, A. A., & Jacobs, T. (2017). Good design practices for GMP pharmaceutical

facilities. Boca Raton, Fl.: CRC Press.

Lund, W. (2009). The pharmaceutical codex: Principles and practice of pharmaceutics. New

Delhi: CBS.

Aulton, M. E., & Taylor, K. (2018). Aulton s pharmaceutics: The design and manufacture of

medicines. Edinburgh: Elsevier.

Gad, S. C. (2008). Pharmaceutical manufacturing handbook production and processes.

Hoboken, NJ: Wiley-Interscience.

Rawlins E.A, Editor: 1977 Bentley’s Textbook of Pharmaceutics, 8th Ed. Baillie're Tindall.

London

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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2

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