GOOD DISPENSING PRACTICE GUIDELINES

Introduction
All pharmacies should be operated such that there is constant assurance that
the service provided and the facilities available are of the appropriate quality.
This is both a legal and ethical requirement.

These guidelines are intended for those currently operating or those intending to
operate pharmacies in Zimbabwe.

Although the guidelines are generally limited to the provisions of the Medicines
and Allied Substances Control Act (Chapter 15:03) , the Medicines and Allied
Substances Control (General) Regulations, 1991 (S.I. 150 of 1991), the
Dangerous Drugs Act (Chapter 15:02) and the Dangerous Drugs Regulations,
1975 (GN 1111 of 1975) and their amendments, other requirements and policies
of the Medicines Control Authority of Zimbabwe (MCAZ) are incorporated as
well.

The guidelines are subject to modifications at the discretion of the MCAZ. They
are also not intended to be the replacement of the Good Pharmacy Practice
guidelines as set out by other organiz ations e.g. the World Health Organization,
The Pharmaceutical Society of Zimbabwe or the Health Professions Council
which may be available from time to time.

MCAZ inspectors when conducting inspections will use these guidelines and any
other specific lega l requirements not mentioned in these guidelines are not
necessarily unimportant.

SECTION A - RETAIL PHARMACIES

Suitability Of Premises

The premises, particularly the dispensary, should be maintained in a

clean and tidy condition.

The premises should have suitable and effective means of natural and
artificial lighting and ventilation.

There should be sufficient space in the dispensary to ensure an efficient

flow of work and effective communication and supervision of all ac tivities in the
front shop. The area of the section to be used as a dispensary should not be

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less than 10 square meters for one pharmacist working there -in with an
additional 2 square metres for each additional Pharmacist. The height of the
premises shou ld be at least 2.5metres.

All working surfaces, cupboards and shelves in the dispensary should be

finished with a smooth, impervious and washable material and maintained in a
good state of repair. Walls, floors and ceilings should be kept clean. A regular
cleaning schedule is recommended.

Toilet facilities should be appropriately located, designed and equipped and

should have adequate hand washing facilities. They should be kept clean and in
efficient order and so designed that no offensive odours penetr ate into the
dispensary. Toilet areas should not be used for the purpose of storing stock or
as a source of water for the preparation of medicinal products.

The working environment (e.g. temperature, lighting, humidity and noise levels)
should be such th at there is no adverse effect on the dispensed product.

Waste material should not be allowed to accumulate and should be

collected in suitably covered receptacles for removal to collection points,
preferably outside the building, for disposal at regular and frequent
intervals.

The processing of substances for non -medicinal use should be effectively

separated from the dispensing of medicinal products.

The premises should be separated from rooms for private use.

Equipment

A pharmacist should satisfy h imself that the equipment on the premises is

adequate and suitable for all the operations that have to be carried out. All
equipment should be kept clean and should be checked for cleanliness prior to
each use. With the exception of non -returnable contai ners, equipment must be
of such material and be kept in such good repair and condition as to enable it to
be thoroughly cleaned to prevent any risk of contamination. Use of stainless
steel and glass is recommended, not enamel or plastics.

Equipment shoul d include:

• A dispensing bench of adequate size having a smooth, impervious

working surface e.g. stainless steel, melamine or formica, to be used
solely for compounding, dispensing and similar operations.

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• A sink in the dispensary with an adequate sup ply of hot and cold running
water.

• A suitable means of counting tablets and capsules, bearing in mind the

need to avoid cross contamination particularly when using mechanical
counters.

• An assized mass meter for dispensing with a comprehensive range of

masspieces and a sensitivity of 30mg.

• A suitable range of graduated, assized glass measures (10, 25, 100 and
500ml)

• A suitable range of pestles and mortars, both glass and earthenware.

• A refrigerator unit capable of storing products within a sel ected

temperature range from 0 to10 C, the efficiency of which should be
checked regularly.

• Suitable means for the sterilisation of medicinal products if prepared on

the premises.

• A suitable range of liquid, tablet and capsule containers.

• A suitable range of containers for medicinal and cosmetic purposes.

• A suitable range of containers for the dispensing of creams and

ointments.

• A suitable range of labels for the above mentioned containers.

• An adequate supply of spatulas.

• Fixed lockable Da ngerous Drugs cupboard clearly marked "Dangerous

Drugs" or "Narcotics".

Cleanliness And Hygiene

All persons engaged in dispensing should observe high standards of personal

cleanliness and protective clothing should be laundered regularly and frequentl y.

Smoking should be prohibited in any area where medicines are dispensed, sold
or supplied.

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Direct contact between the operator's hands and the dispensed products should
be avoided.

Control Of Materials

The compounding and dispensing of medicinal pro ducts should be carried

out by a pharmacist or by registered persons under the personal
supervision of a pharmacist.

The compounding and dispensing of medicinal products should be subject to an

adequate control system.

All raw materials in the compound ing and dispensing of medicines, must comply
with official medicine control requirements.

All containers of raw materials should be kept in a good, clean condition, clearly
labeled, and should have identifying reference marks, manufacturer's
name and, ba tch numbers and expiry dates clearly marked on them.

All materials should be stored under suitable conditions, bearing in mind the
nature of the material concerned. Particular attention should be paid to
protection from sunlight, atmospheric moisture and adverse temperature. Where
materials are transferred from one container to another the particulars
specified in (iv) above should also be transferred and the risk of contamination
reduced. A pharmacist should exercise his knowledge of stability of mate rials
and should dispose of substances which have deteriorated or the expiry dates of
which have lapsed.

General

Containers used in dispensing should be appropriate to the particular product

being dispensed, bearing in mind particularly the need to prot ect the contents
from the adverse effects of atmospheric moisture, sunlight, transportation and
handling by the patient.

Labels of medicinal products should be legible and clear.

An appropriate filing system should be established for those documents requ ired
to be kept under various enactments.

A prescription book or other permanent record should be used for recording

dispensed prescriptions and counter -prescribed items.

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Reference books as may be prescribed by the Authority from time to time, should
be available in the pharmacy.

Books: Latest Edition or last but one edition of Martindale, BNF, Latest EDLIZ,
up to date DASCA/DASCR and DDA and DDR should be available.

SECTION B: HOSPITAL PHARMACIES

Apart from the requirements listed under Section A, ho spital pharmacies should
also comply with the following:

Suitability Of Premises

The dispensary should be a separate, independent unit.

Air-conditioning in the dispensary is mandatory.

Floors should be provided with a sealed vinyl coating or chemical r esistant

ceramic tiles and walls and ceilings should be coated with epoxy paint.

Refuse should not be permitted in the dispensary and disposal should take place
by means of external refuse containers with securely fastened covers or by
means of a wall -mounted shute with a springloaded flap on the inside.

Equipment

Only stainless steel and/or glass mixers, containers and measures should
be used.

Water used in the dispensary should be distilled, de -ionised and bacteria free.

Pre-packing of tablets and c apsules must take place in a separate area within
the dispensary and the use of an electronic counting machine is desirable.

Only electronic mass meters may be used.

A suitable refrigerator must be available in the dispensary.

Sterilizing of medicines may only be done by an autoclave.

Cleanliness And Hygiene

The wearing of appropriate protective clothing is compulsory.

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Smoking and eating should not be permitted in the dispensary.

All raw materials used in the dispensary should conform at least to BP , EP or

USP Standards.

NB: The above requirements are subject to modifications at the discretion of the
Authority, to relax or impose additional requirements in any particular case.