5.10 PREMISES AND EQUIPMENT

One of the major requirements needed for the manufacturing of a pharmaceutical

product is premises and the other one is equipment. The premises and equipment

Fig. 5.6: The steps involved in the AMT of a drug product

Fig. 5.7: The steps involved in the AMT of a drug substance (non-pharmacopoeial)

82 Industrial Pharmacy II

should be designed, constructed, located, adapted and maintained to suit the operations

needed to be carried out. It is a layout of premises and equipment that have major

effect on cleaning, maintenance, and risk of error during production and finally affect

the quality of the product.

Premises

SU’s responsibilities:

To provide information to RU on

i. Design

ii. Layout

iii. Construction

iv. Services (HVAC, temperature, relative humidity, water, power, etc.)

To provide other information which may directly or indirectly have an impact on

the method, product and process.

Fig. 5.8: The steps involved in the AMT of a drug substance (pharmacopoeial)

WHO Guidelines for Transfer of Technology 83

SU should provide information related to safety, health and related environmental

issues. This includes:

i. Risks inherited in manufacturing processes like exposure limits, chemical hazards,

fire risks, and explosion risks, etc.

ii. Measures or health and safety essentialities to minimize or reduce the operator

exposure. For example, the case of pharmaceutical dust.

iii. Emergency plans in case of non-predictable situations like gas leakage, dust

release, fire, etc.

iv. Waste management plan

RU’s responsibilities: RU should compare all the information with its own premises

details and ensure the production of quality products.

Equipment

Equipment used in the pharma industry includes equipment related to manufacturing,

packaging, processing, and holding of the drug. All equipment should be located,

maintained and designed to suit their intended purposes related to the operation.

SU’s responsibilities: SU should provide RU with the list of equipment (of all units

such as manufacturing, packaging, filling, quality control, etc.) with designs, models

and makers. The list should be updated and recent. SU should also provide qualification

and validation documentation which includes:

Logs (maintenance and calibration), manuals, drawings, procedures related to

equipment set up, cleaning, maintenance, storage, etc.

RU's responsibilities: RU should review the information provided by SU with its

inventory list. This list should include:

i. Qualification status of all systems and equipment

ii. Comparison of equipment (related to functionality, models, makes, and

qualification status) at both sides.

A gap analysis should be performed by RU. The factors that are to be analysed

during gap analysis are as follows: