Components of GMP Total Session Time: 120 minutes

Session 2: Components of GMP

Total Session Time: 120 minutes

Prerequisites

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

2 05 minutes Presentation Overview of GMP Components

3 20 minutes Presentation Components of GMP

80 minutes Presentation

4 General Premise Requirements of GMP

Group Discussion

5 05 minutes Presentation Key points

05 minutes Presentation

6 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: Overview of GMP Components (5 minutes)

helps to ensure that pharmaceutical products are consistently produced with the quality

standards appropriate for their intended use

general measures to ensure that processes necessary for production and testing are clearly

defined , validated reviewed and documented and that the personnel, premises and

material are suitable for the production of pharmaceuticals and biological including

vaccines.

STEP 3: Components of GMP (20 minutes)

The following are components of GMP:

STEP 4: General Premise Requirements (80 minutes)

Activity: Brainstorming (5minutes)

ASK students to brainstorm on the following question for 5 minutes

ALLOW students to brain storm for 5minutes

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

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

relation to any building includes a part of a building and any cartilage, forecourt, yard, or

place of storage used in connection with building or part of that building; and in relation

to ''vessel'', means ship, boat, air craft, and includes a carriage or receptacle of any kind,

whether open or closed. (TFDC Act 2003).

o The land and buildings where the manufacturing operations are located must

contribute towards the quality of the products. They do this by avoiding the risks of

contamination, permitting effective cleaning and maintenance, minimizing the build-

up of dirt and dust and preventing quality defects. .

o The geography of the chosen location can have a considerable impact upon the design

of facilities. Is the location subject to earthquake hazards? Does it experience

flooding regularly – during the monsoon season? What precautions need to be taken

regarding continuity of supply of services?

o The climate of the area is also important. If the company will be handling, for

example, gelatine capsules then humidity are of great concern. If the company has a

lot of goods requiring temperature or humidity controls in transport, and the goods

have to sit on the dockside for weeks waiting for a boat to arrive, there may be a

problem with the quality of the products. The company may need to rent

temperature-controlled storage. If it does, how will it check the quality of that

storage?

that arise. Does the process make a lot of noise, for example? If it does and the location

is close to neighbours, then the company may be forced into expensive soundproofing.

then the design precautions that it will have to take, and the level of maintenance that it

will have to undertake, will be very different than if it is in a rural setting. If the

neighbours change, the company will need to take appropriate measures to handle the

situation correctly.

surrounding area with product or by-products from its manufacturing processes.

for the construction of a pharmaceutical factory

o The layout and design of premises must aim to minimize the risk of errors and permit

effective cleaning and maintenance in order to avoid cross-contamination, build-up of

dust or dirt, and, in general, any adverse effect on the quality of products.

o Premises should be carefully maintained, and it should be ensured that repair and

maintenance operations do not present any hazard to the quality of products.

o Electrical supply, lighting, temperature, humidity and ventilation should be

appropriate and such that they do not adversely affect, directly or indirectly, either the

pharmaceutical products during their manufacture and storage, or the accurate

functioning of equipment.

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

o Premises should be designed to ensure the logical flow of materials and personnel

corresponding to the sequence of the operations and to the requisite cleanliness levels.

o Interior surfaces (walls, floors and ceilings) should be smooth and free from cracks

and open joints, should not shed particulate matter, and should permit easy and

effective cleaning and, if necessary, disinfection.

o Facilities for changing and storing clothes and for washing and toilet purposes should

be easily accessible and appropriate for the number of users. Toilets should not

communicate directly with production or storage areas.

o Interior surfaces (walls, floors and ceilings) should be smooth and free from cracks

and open joints, should not shed particulate matter, and should permit easy and

effective cleaning and, if necessary, disinfection.

o Facilities for changing and storing clothes and for washing and toilet purposes should

be easily accessible and appropriate for the number of users. Toilets should not

communicate directly with production or storage areas.

o Printed packaging materials are considered critical to the conformity of the

pharmaceutical product to its labeling and special attention should be paid to sampling

and the safe and secure storage of these materials.

o There should normally be a separate sampling area for starting materials. (If sampling

is performed in the storage area, it should be conducted in such a way as to prevent

contamination or cross contamination.)

o Highly active and radioactive materials, narcotics, other dangerous drugs, and

substances presenting special risks of abuse, fire or explosion should be stored in safe

and secure areas.

o The weighing of starting materials should be carried out in separate weighing areas

designed for that use, for example with provisions for dust control. Such areas may be

part of either storage or production areas.

o Pipe work, light fittings, ventilation points and other services should be designed and

sited to avoid the creation of recesses that are difficult to clean. As far as possible, for

maintenance purposes, they should be accessible from outside the manufacturing

areas.

o Production areas should be effectively ventilated, with air control facilities (including

filtration of air to a sufficient level to prevent contamination and cross-contamination,

o Production areas have control of temperature and, where necessary, humidity.

o Drains should be of adequate size and designed and equipped to prevent back-flow.

Open channels should be avoided where possible, but if they are necessary they

should be shallow to facilitate cleaning and disinfection.

o Quality control laboratories should be separated from production areas. Areas where

biological, microbiological or radioisotope test methods are employed should be

separated from each other.

o Quality control laboratories should be designed to suit the operations to be carried out

in them. Sufficient space should be given to avoid mix-ups and cross-contamination.

There should be adequate suitable storage space for samples, reference standards (if

necessary, with cooling), solvents, reagents and records.

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

o The design of the laboratories should take into account the suitability of construction

materials, prevention of fumes and ventilation. There should be separate air supply to

laboratories and production areas. Separate air-handling units and other provisions are

needed for biological, microbiological and radioisotope laboratories.

o A separate room may be needed for instruments to protect them against electrical

interference, vibration, contact with excessive moisture and other external factors, or

where it is necessary to isolate the instruments.

STEP 5: Key Points (5 minutes)

control of raw materials.

o Quality control of finished products

o Written procedures & other documentation

building include a part of a building and any cartilage, forecourt, yard.

neighbourhood

STEP 6: 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.

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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