9. Preparation of master manufacturing procedures: The manufacturing procedure

includes manufacturing directives, sampling directions, weight sheet, finished and

in-process product specifications. This section is related with the manner of

presentation of manufacturing procedures which helps in facilitating easy

compliance and understanding of processing technicians.

10. Product stability and uniformity: Each pilot-plant batch should be studied for

stability. The physical, as well as chemical stability studies, should be performed

on pilot-plant batches. The stability studies of finished packages should be carried

out.

11. Good Manufacturing Practices (GMP) Considerations: This section includes the

following items of GMP that are to be considered while the pilot-plant 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.

12. Transfer of analytical methods to quality assurance: In research, all analytical

methods must be transferred to the quality assurance department during the

44 Industrial Pharmacy II

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.

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

The main responsibility of the 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 scaleup is of such type that will promote maintenance and cleanliness. It should be located

on the 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 pilotplant 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 packaging area, should be of enamel

cement finish.