NTA Level 6 • Semester 1 • PST06103

GMP for Pharmaceutical Equipments

Pharmaceutical Production • Source Session/Topic 24

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Session 24: GMP for Pharmaceutical Equipments

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

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

• Explain the GMP requirements for equipment used in pharmaceutical

manufacturing

• Explain the construction features of GMP compliant equipment

• Outline the basic equipment used in pharmaceutical production

• Explain the calibration of equipment used in pharmaceutical production

• Explain the cleaning of equipment used in pharmaceutical production

• Explain the preventive maintenance of equipment used in pharmaceutical

production

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

SESSION OVERVIEW

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 |

| |

|What are the features of pharmaceutical manufacturing equipment? |

| |

|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 |

• Equipment used in the manufacture, processing, packing or holding of a

drug product must be of appropriate design, adequate size, and suitably

located to facilitate operations for its intended use and for its

cleaning and maintenance

• Effectiveness of equipment starts at the design stage

• Pharmaceutical manufacturing companies contribute indirectly in the

design of equipment by providing information on requirements and feedback

on existing equipment

• Equipment must be located, designed, constructed, adapted and maintained

to suit the operations to be carried out

• Equipment should be constructed of materials that suit the operation and

use of the equipment for the range of products manufactured and tested on

site.

• The construction materials should not corrode or deteriorate and thus

influence the manufacturing or testing procedure.

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 |

| |

|What are the GMP requirements for equipment used in pharmaceutical |

|production? |

| |

|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 |

• Pharmaceutical manufacturing equipment should meet the following

requirements;

o Operating criteria

▪ 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)

• Equipment layout and design must aim to minimize risks of error and

permit effective cleaning and maintenance

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

adverse effect on the quality of the product

• Equipment must be installed to minimize risks of error and contamination

• The construction of the equipment must meet the following features;

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)

▪ 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 (25 minutes)

• Balances and measuring equipment

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

• Production equipment

o Production equipment must be suitably designed for the intended uses

o Must 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

• Control laboratory equipment

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

• Washing, cleaning and drying equipment

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 (25 minutes)

• Equipment and utensils must be cleaned, maintained and sanitized at

appropriate intervals 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

• Calibration of equipment

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

• Cleaning and Preventive Maintenance

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.

▪ The SOPs should include;

• Assignment of responsibility for cleaning and maintaining

equipment

• Maintenance and cleaning schedules

• Descriptions of methods, equipment and materials used in

cleaning and maintenance operations. Methods for disassembling

and reassembling equipment to ensure proper cleaning and

maintenance

• Removal or obliteration of previous batch identification

• Instruction for the protection of clean equipment from

contamination prior to use

• Inspection of equipment for cleanliness immediately before use,

if practical

• Establishing the maximum time that may elapse between the

completion of processing and equipment cleaning, when

appropriate

• Documentation

o Records of calibration, cleaning and preventive maintenance of all

equipment must be kept properly

STEP 6: Key Points (5 minutes)

• Equipment used in the manufacture, processing, packing or holding of a

drug product must be of appropriate design, adequate size, and suitably

located to facilitate operations for its intended use and for its

cleaning and maintenance

• Equipment in pharmaceutical manufacturing must meet GMP requirements

• Equipment layout, design and construction must aim to minimize risks of

error and permit effective cleaning and maintenance

• Equipment must be installed to minimize risks of error and contamination

• Basic equipment in pharmaceutical production include weighing and

measuring equipment, production equipment, quality laboratory equipment

and equipment for washing, cleaning and drying

• Equipment must be calibrated, cleaned and maintained properly to ensure

safety, quality and effectiveness of drug products

STEP 7: Evaluation (5 minutes)

• Why is the design of equipment important in pharmaceutical production?

• What are the GMP requirements for pharmaceutical equipment?

References

Aulton M.E & Kevin M.G, (Eds.): (2013) Pharmaceutics: The design and

manufacture of medicines, (4th ed.) Churchill Livingstone

Hugo and Russell (2011), Pharmaceutical Microbiology (8th ed.), Willey-

Blackwel publications

Gennaro, R. A, et al. (Eds) (1995) Remington: The Science and Practice of

Pharmacy, Volume I & II, (19th ed): Mack Publishing Company, Easton,

Pennsylvania 18042

Liebsch, B et al. (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam

University Press.

Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice

of Pharmaceutics (12th ed.) The Pharmaceutical Press, London

Polderman, J., (1990) Introduction to Pharmaceutical Production: Novib, The

Hague

Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, (8th ed).

Baillie're Tindall. London Kamm, G. and Kohler, B. Editors: (1995)

Manual for Decentralized Infusion Production, Infusion Unit Project

Tanzania

Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press,

Colorado.

Shayne C et al. (2008), Pharmaceutical Manufacturing Handbook: Production

and processes, John Wiley & Sons

Watson, D. G (1999) Pharmaceutical Analysis: A Textbook for Pharmacy

Students and Pharmaceutical Chemists: Churchill Livingstone, Edinburgh

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