Pharmaceutical Manufacturing Handbook: Production and

318 LIQUID DOSAGE FORMS
design, building, and installation; equipment selection and acquisition; personnel
selection and initial training; and monitoring information system.
Liquid Preparation Research and development of protocols concerning liquid
compounding; scale - up of the bulk product compounding; physical plant control
and maintenance; equipment maintenance and renovation; continuous
training of personnel and personnel compensation plan; and supervision of
system reports.
Filling and Packing Research and development of protocols concerning fi lling
and packing; scale - up of the fi nished drug product fi lling and packing; physical
plant control and maintenance; equipment maintenance and renovation; continuous
training of personnel and personnel compensation plan; and supervision
of system reports.
Sales of Drug Products Research and development of protocols concerning
product storage; distribution process; continuous training of personnel and
personnel compensation plan; and supervision of system reports.
Vendor Handling Research and development protocols concerning precautions
to maintain product stability; control of vendor stock; and sales system
reports.
Customer Service Research and development of protocols concerning home
storage and handling to maintain product stability; relations with health insurance
companies and health care professionals; educational materials for patient
counseling; and customer service system reports.
4.3.2.10 Protocols
Protocols are patterns developed by repeating procedures and fi xing the identifi ed
problems each time that the procedure is followed. Therefore, protocols are dynamic
entities that originally can be developed at a laboratory level but must be adjusted
in every new step of the scal - up process. When the manufacturing process moves
up in scale, the number of people affected by the protocol increases geometrically.
Initially, the information can be obtained from library references, personal tests,
interpersonal training, and previous laboratory protocols. However, when the production
is scaled up, the information required to fi ne tune the process comes from
monitoring the process itself [2] .
4.3.3
APPROACHES
Quality by Design is a systemic approach that applies the scientifi c method to the
process. QbD theory contains components of management, statistics, psychology,
and sociology. The FDA ’ s new century has identifi ed the QbD approach as its “ key
component ” based on process quality control before industry end results [3, 17] .
The cooperation between industry members and regulators is increased when the
industry explains clearly what it is doing and the agency can understand the formulation
and production process. In these cases, regulatory relief appears when industry
explores its issues and receives active guidance and programs from the FDA.
The agency takes the role of facilitator, or even partner of the industry, in order to
improve the strength of the process and formulation [3, 17] .