NTA Level 6 • Semester 1 • PST06103

GMP for Pharmaceutical Premises

Pharmaceutical Production • Source Session/Topic 23

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Session 23: GMP for Pharmaceutical Premises

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 concept of GMP on pharmaceutical premises

• List the general GMP Requirements on Design of Premises

• Explain how pharmaceutical manufacturing premises are maintained

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: GMP and Manufacturing Premises (20 minutes)

• Good Manufacturing Practices (GMP) are a part of Quality Assurance (QA)

which ensures that products are consistently produced and controlled to

the quality standards appropriate to their intended use

• GMP is designed to minimize the risks involved in any pharmaceutical

production that cannot be eliminated through testing the final product

• GMP covers all aspects of production;

o Raw materials

o Premises

o Equipment

o Personnel

• Principles of GMP are;

o Proper design and construction of premises

o Following written procedures and instructions

o Documentation of work

o Validation of work

o Monitoring facilities and equipment

o Writing SOPs

o Designing, developing and demonstrating job competence

o Protection against contamination

o Controlling components and product related processes

o Conducting planned and periodic audits

• The premise for pharmaceutical production must meet the GMP standards

STEP 3: General GMP Requirements on Location of Premises (25 minutes)

• The land and buildings where the manufacturing operations are located

must contribute towards the quality of the products

• Proper location and design help avoid the risks of contamination,

permitting effective cleaning and maintenance, minimizing the build-up of

dirt and dust and preventing quality defects

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

for production processes to;

➢ Minimize risks of errors and cross-contamination

➢ Permit effective cleaning

➢ Permit effective maintenance

➢ Minimize build-up of dirt and dust

➢ Eliminate any adverse effects on quality

• Principle for the location of pharmaceutical production premise;

o Location must minimize risks of cross-contamination

▪ Not located next to a melting factory with high airborne levels

of yeast

o Location must be in conducive climatic and geographic (e.g. away from

noise, earthquake hazards, flooding, humidity, )

• A site inspection is useful before building commences to ensure that the

area is suitable for the construction of a pharmaceutical factory

STEP 4: General GMP Requirements on Design of Premises (40 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 on design of premise? |

| |

|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 |

• Premises should be laid out in such a way as to allow the production to

take place in areas connected in a logical order corresponding to the

sequence of the operations and to the requisite cleanliness levels

• Working and in-process storage space should be adequate to permit orderly

and logical positioning of equipment and materials to minimize risk of

confusion between different pharmaceutical products or their components,

to avoid cross-contamination and to minimize the risk of omission or

wrong application of any of the manufacturing or control steps

• The premise must have good pipe work, light fittings and ventilation

points (air handling system)

• Design of the premise must include the following design features;

o Design of facilities required

▪ Adequate space for future expansion

▪ Zoning laws –to allow anticipated development, restricting

undesirable developments in the vicinity

▪ Availability of water (quality and quantity), power, fuel, sewage

and waste removal

▪ Accessibility to employees, materials and visitors

▪ Environmental issues such as site history (soil, water, and air

quality)

▪ Proximity of undesirable activities likely to cause pollution

▪ Availability of a suitable labour force

▪ Ability to provide adequate security arrangements

▪ Political situation

▪ Government stability, trade policies and taxation, financial

incentives

o Design of Ancillary areas

▪ Rest and refreshment rooms must be separated from manufacturing

and control areas

▪ Facilities for changing and storing clothes and for washing

appropriate to the number of workers

▪ Toilets should not communicate directly with production or

storage areas

▪ Maintenance workshops (should be separated from production area)

▪ Animal houses should be well isolated from other areas with

separate entrance (animal access) and air handling facilities

o Design of Storage areas

▪ Storage areas should have sufficient capacity for orderly storage

of various categories of materials and product with proper

separation and segregation

▪ Storage areas should be designed or adapted to ensure good

storage conditions

▪ Special storage conditions (provided, controlled, monitored and

recorded appropriately)

▪ Quarantine area must be allocated to restrict access to

unauthorized personnel

▪ Secure areas for storage of controlled substances and radioactive

pharmaceuticals

▪ Storage area should be designed such that receiving and dispatch

batches are separated to protect materials and products from the

weather

▪ Receiving areas should be designed and equipped to allow

containers of incoming materials to be cleaned if necessary before

storage

▪ There are should a separate area for sampling of raw materials to

avoid contamination if sampling is done in the storage area

▪ Storage area must have a weighing area, close to the production

area to avoid or minimize transit distance

o Design for production areas

▪ Dedicated and self-contained facilities must be provided for

production of particular pharmaceutical products (e.g. penicillin

or biological preparations)

▪ Manufacture of technical poisons e.g. pesticides and herbicides

must never be allowed in premises for manufacture of pharmaceutical

products

o Design for quality control areas

▪ Quality control laboratories should be separated from production

areas

▪ Areas for biological, microbiological or radioisotope test

methods are employed should be separated from each other

▪ Quality control laboratories should be designed to suit the

operations to be carried out

▪ Sufficient space should be given to avoid mix-ups and cross-

contamination

▪ Should prevent fumes and allow ventilation

▪ There are should be separate air supply to laboratories and

production areas

▪ Separate air handling units and other provisions are needed for

biological, microbiological, and radio-isotope laboratories

▪ A separate room may be needed for instruments

o Design for services

▪ In the building design provisions must be made for drains, water,

steam, electricity and other services to allow easy of maintenance

▪ Access should be possible without disruption of activity with the

actual rooms provided with the services

o Construction features

▪ Adequate space for orderly placement of equipment and materials

▪ Adequate space to allow flow of components, drug product

containers, closures, labelling, in-process material and drug

products to prevent contamination

▪ Floors, walls and ceilings should be smooth, hard surfaced for

easy cleaning

▪ Should have temperature and humidity controls

▪ Air supply filtered through high-efficiency particulate air

(HEPA) filters under positive pressure, regardless of whether the

flow is laminar or nonlaminar

▪ There are should be a system for monitoring environmental

conditions;

▪ Cleaning and disinfecting rooms and equipment

▪ Maintenance of equipment used to control aseptic conditions

▪ Adequate lighting in all areas

▪ Ventilation, air filtration, air heating and cooling

▪ Adequate ventilation

▪ Air filtration system

▪ Pre-filters and particulate matter air filters are used to

control recirculation of dust

▪ Air handling system

▪ For manufacturing, processing and packing of penicillin must be

separate from those of other drug products for human use

▪ Plumbing

▪ Portable water is supplied under continuous positive pressure in

a plumbing system free of defects that could contribute to

contamination

▪ Drains should prevent back-siphonage

▪ Sewage, trash and other refuse in and from the building and

immediate premises must be disposed of in a safe and sanitary

manner

▪ Pharmaceutical industry considers disposal in forms of;

• Product disposal

• Printed packaging disposal

• General trash and sewage

▪ Washing and toilet facilities

▪ Adequate washing facilities must be provided

▪ with hot and cold water, soap or detergent, air driers or single-

service towels

▪ adequate and clean toilet facilities easily accessible to working

areas

STEP 5: Maintenance of Premises (20 minutes)

|Activity: Buzzing (5 minutes) |

| |

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

|minutes |

| |

|How are premises for pharmaceutical manufacturing maintained? |

| |

|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 |

• Buildings used in manufacture processing, packing or holding of a drug

product must be maintained in good state of repair

• The following must be maintained;

o Cracks and holes in the wall, floor and ceilings

o Damage to insulation or pipes

o Dust accumulation on light fittings etc

• Building inspection and maintenance programs should be defined in writing

and records kept

• Essential services to monitor include water, steam, vacuum, compressed

air and other gases, electricity, dust extraction, product/material pipe

line and drainage

STEP 8: Key Points (5 minutes)

• The premise for pharmaceutical production must meet the GMP standards

• The land and buildings where the manufacturing operations are located

must contribute towards the quality of the products

• Proper location and design help avoid the risks of contamination,

permitting effective cleaning and maintenance, minimizing the build-up of

dirt and dust and preventing quality defects

• Premises should be laid out in such a way as to allow the production to

take place in areas connected in a logical order corresponding to the

sequence of the operations and to the requisite cleanliness levels

• Buildings used in manufacture processing, packing or holding of a drug

product must be maintained in good state of repair

STEP 7: Evaluation (5 minutes)

• What are the GMP requirements for premises?

• Mention design features of a pharmaceutical manufacturing premise

• Mention the construction features of a pharmaceutical manufacturing

premise

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.

WHO (2003), Good Manufacturing Practices for Pharmaceutical Products, Annex

4 to WHO Technical Reports Series, No. 908.

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