1. a 2. a 3. a 4. a 5. d 6. c 7. 1(d), 2(c), 3(a), 4(b)

8. a. money, material, machine

b. prototype, pilot-plant

c. laboratory

d. scale-up

e. calibration, QA QC activities, labelling.

General Considerations and Pilot-Plant Considerations for Different Dosage Forms 9

2.1 GENERAL CONSIDERATIONS (Fig. 2.3)

General consideration includes the following points to be kept in mind while planning

for scale-up.

2.1.1 Reporting Responsibilities (Fig. 2.1)

There should be adequate records and reporting arrangements to make the transfer of

products from laboratory-scale to a commercial-scale smooth. The transfer is a

multidisciplinary approach as it includes pilot-plant group and other groups like R&D,

processing, engineering, quality assurance, regulatory, marketing, etc. There should

be good communication and relationship between pilot-plant groups and other groups.

R&D group should be with separate staffing. Production department can be under

formulator and formulator can provide support even after the transition of production

has been completed.

2.1.2 Personnel Requirement

It is very important for the smooth transfer of products (from laboratory-scale to pilotplant and then to commercial-scale) to have well-qualified staff. They should have

good knowledge about pharmacy and pharmaceutical industry. Those employed for

9

General Considerations and

Pilot-Plant Considerations for

Different Dosage Forms

2