NTA Level 6 • Semester 1 • PST06103

Dispensing of Pharmaceutical Materials

Pharmaceutical Production • Source Session/Topic 7

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Session 7: Dispensing of Pharmaceutical Materials

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

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

• Dispensing of raw materials

• Describe dispensing area for raw materials

• List equipment used in dispensing of raw materials

• Explain the dispensing of raw materials

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: Dispensing and Dispensing Area (20 minutes)

• Dispensing of raw materials is the process whereby raw materials required

for production are identified, weighed or measured and transferred to the

production area

• Every pharmaceutical manufacturing plant must have an area in which raw

materials are weighed and transferred in clean containers to the

production area

• The area where dispensing takes place is known by various names including

weighing bay, weighing area, weighing room, central weigh, pharmacy or

dispensing room

• Features of a weighing room include;

o Unidirectional flow of materials and personnel

o Segregation between hazardous and non-hazardous materials

o Separation of storage and manufacturing items and space

• The weighing room is the entry point to manufacturing and the transition

point for materials coming from the warehouse and entering processing

areas

• The dispensing areas is commonly comprised of;

o Weighing area

▪ Where actual weighing or measuring of raw materials is done

o Raw material staging area

▪ When weighing is complete, there may still be material left in

the containers received from the client

▪ Large quantities are usually returned to the warehouse, but small

quantities, especially of those materials that will be used again

soon, can be stored on pallets or on shelving in raw material

staging areas (materials requiring special storage conditions not

provided by the raw material staging area are returned to their

appropriate storage locations in the warehouse)

o Work-in-process

STEP 3: Dispensing Equipments (20 minutes)

|Activity: Buzzing (5 minutes) |

| |

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

|minutes |

| |

|Which equipments are used in dispensing of raw materials? |

| |

|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 |

• Dispensing equipment include the following;

o Scales

▪ Size of scale used is determined by capacity of materials to be

weighed

▪ Example is a pit-mounted floor scale

o Pippetes

o Calibrated measuring containers

o Fume cabinets

o Labels/printers and related instrumentation

• All equipment must be calibrated and maintained regularly to minimize

errors

o Routine testing must be carried out for all the balances being used in

the facility

• All dispensing equipment must be documented properly

• There should be SOP for using each equipment

STEP 4: Preparation for Dispensing Raw Materials (25 minutes)

• Before any dispensing activity is done, the warehouse, in-process quality

control and production personnel must ensure that ;

o The dispensing area and dispensing equipment are cleaned

o Differential pressure, temperature and relative humidity of the

dispensing area are within the specified limits

o Documents related to previous products are removed from dispensing

area

o All the log books of the respective areas are updated

o Approved materials are to be dispensed

o The reverse laminar flow (RLAF) is switched on 15 minutes before

dispensing activity starts

• Production personnel is responsible for calculating the quantity of

active pharmaceutical ingredients (APIs) and excipients (and adjustments

according to standard batch size, if applicable) as outlined in the Batch

Manufacturing Record (BMR)

o The calculations are verified by in-process quality control personnel

• Personnel enter the dispensing area through the personnel airlock with

proper gowning

• Dispensing is only done in controlled conditions under reverse laminar

air flow

STEP 5: Dispensing Process for Pharmaceutical Raw Materials (40 minutes)

|Activity: Small Group Discussion (10 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|Explain the dispensing procedures for raw materials? |

| |

|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 Receipt of “Dispensing of Raw Material Sheet”

▪ The Batch Manufacturing Record (BMR) contains a list of raw

materials to be dispensed known as Dispensing of Raw Material sheet

▪ All raw materials are dispensed as per quantities mentioned in

the “dispensing of raw material” sheet of the BMR

o Verification of Availability

▪ Warehouse personnel verifies the availability of the approval

status of required raw materials

▪ A raw materials stock card of respective raw material is used to

facilitate the verification process

o Dispensing the raw material

▪ After verification of availability, warehouse personnel dispenses

the raw material

▪ All raw material are dispensed as per First Expiry First Out

(FEFO) followed by First In First Out (FIFO) system

▪ Sterile raw materials are dispensed while in their intact

packs

▪ Dispensed raw materials are transferred from approved raw

material storage area to the raw material dispensing area one by

one through the material entry air lock

▪ Inactive ingredients (excipients) are dispensed before the

active ingredients except colours and flavours are dispensed

last

▪ Dispensing of additional raw materials

▪ Additional raw materials are dispensed and issued to the

production department under the following circumstances;

• on line rejection

• spillage and wastage of material during transit or production

activity

o production department must raise a requisition for the additional

requirement of material duly authorized by head of quality assurance

after investigating the additional requirement for raw material

▪ Loose packs of raw materials (remaining after dispensing) are

cleaned, sealed, labelled “loose” and transferred through the

material entry air lock one by one back to their respective storage

areas

o Documentation of dispensed raw material

▪ Warehouse personnel then document the dispensed raw material

appropriately

▪ The warehouse fills the BMR sheet and stock cards as required

▪ Batch number, assay, % of moisture content, manufacturing

date, expiry date, quantity dispensed

▪ If additional materials have been dispensed, the details of

additional materials issued are recorded in material stock card

and supplementary slip for raw materials and attached to the BMR

o Transfer of raw materials

▪ Dispensed raw materials are transferred to the raw material

dispensed quarantine area through the airlock and kept on clean

pallets

o Cleaning the dispensing area and dispensing equipment

▪ After completion of dispensing activity, dispensing equipment and

the dispensing area are cleaned thoroughly according to cleaning

procedures

▪ Cleaning activity is recorded in appropriate records

STEP 6: Key Points (5 minutes)

• Dispensing of raw materials is the process whereby raw materials required

for production are identified, weighed or measured and transferred to the

production area

• Every pharmaceutical manufacturing plant must have an area in which raw

materials are weighed and transferred in clean containers to the

production area

• The area where dispensing takes place is known by various names including

weighing bay, weighing area, weighing room, central weigh, pharmacy or

dispensing room

• The main equipment used in the dispensing of raw materials is the scale

• Before raw materials are dispensed, the dispensing area and equipment

must be cleaned

STEP 7: Evaluation (5 minutes)

• What is dispensing of raw materials?

• List the equipment used in dispensing of raw materials

• What guides the dispensing process for raw materials?

References

Aulton M.E (ed) (1988) Pharmaceutics: The science of dosage form design.

Churchill Livingstone, Edinburgh

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 Edition: 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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