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This section includes the following items of GMP that are to be considered while pilotplant or scale-up “studies”.

i. Equipment qualification

ii. Process validation

iii. Regularly scheduled preventative maintenance

iv. Regular process review and revalidation

v. Relevant written standard operating procedures

vi. The use of competent, technically qualified personnel

vii. Adequate provision for training of personnel

viii. A well-defined technology transfer system

ix. Validated cleaning procedures

x. An orderly arrangement of equipment for easy material flow and prevention of

cross-contamination.

2.1.12 Transfer of Analytical Methods to Quality Assurance

In research, all analytical methods must be transferred to the quality assurance

department during the scale-up of new product. The quality assurance staff should

review the process and make sure that (a) the proper analytical instrumentation is

available and (b) that personnel are trained to perform the tasks.

The assay procedure and the data (that is obtained during validation studies) should

be analysed by research personnel obtained to verify that the analytical methods have

not been altered. This is done to ensure that this alteration should not affect the

precision, reliability or accuracy of the tests.

2.2 PILOT-PLANT SCALE-UP CONSIDERATIONS FOR SOLIDS (TABLETS)

The main responsibility of pilot-plant scale-up is to make sure that the newly formulated

dosage form developed by product development personnel will prove to be efficiently,

consistently and economically reproducible on large-scale production also.

Pilot-plant Design for Solids

The design and construction of the pilot-plant scale-up are of such type that will

promote maintenance and cleanliness. It should be located on ground floor which will

help in the expedition of delivery and shipments of supplies as well as products. Pieces

of equipment which are to be used in the pilot-plant should be similar to that which

will be used during large-scale production. The measures should be taken to avoid

any extraneous and microbial contamination. These measures will include the following:

i. Fluorescent lighting fixtures should be of ceiling flush type.

ii. Air-conditioned and humidity controlled area should be there.

iii. The installation of the high-density concrete floor should be there.

iv. The wall in the processing area as well as the packaging area should be of enamel

cement finish.

14 Industrial Pharmacy II

1. Material handling system: At laboratory-scale production the materials are small

in quantity and easy to handle but at intermediate or large-scale production the

materials’ quantity also increases which makes handling of these materials necessary.

Cross-contamination should be prevented in case of the same system is used for the

transfer of more than one type of material. The material handling system should

have accurate material delievery. Characteristics of the materials should be

considered before choosing material handling system. The material handling systems

like vacuum loading systems, metering pumps and screw feed system are considered

as more sophisticated methods of handling the materials.