PROCESS DEVELOPMENT AND CLINICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 101

valid conclusions. The integration of science and risk management should allow
for successful product development as is shown later.
Regional GMPs have considered the need for controls in clinical product
manufacturing for quite some time.
Medicinal products must be designed and developed in a way that takes into
account the requirements of good manufacturing practice (GMP) [4].
Any drug product intended for human use must be manufactured in accordance
with the GMP or it is considered adulterated [5].

6.2 BASIS FOR DESIGN—TARGET PRODUCT PROFILE AND
PRELIMINARY HAZARD ANALYSIS

In order to achieve product realization, a basis for design is needed to facilitate
the transformation from idea to product. The basis for design of a pharmaceutical
product is the quality target product profile (QTPP) defined in ICH Q8R1 [6] as

“A prospective (but dynamic) [7] summary of the quality characteristics of a drug
product that ideally will be achieved to ensure the desired quality, taking into account
safety and efficacy of the drug product.”

The QTPP forms the basis of design for the development of the product and
the process and should be one of the very first documents to be placed in a
product specification or design history file [8]. The first version of a QTPP for a
new product might look something such as the one shown in Figure 6.1 and is
also a good starting point for the initial risk assessment.

Quality Attribute Target

Immunocompromised

Target Population

Oral

Route of administration

Dosage form

Tablet

0.6 mg

Strength

Securitainer, plastic cap with polythene liner and paper overseal,
dessicant

Packaging

3 years at room temperature

Stability

Immediate release enabling tmax in 2 hours or less

Pharmacokinetics

White to pale yellow, round with break mark

Appearance

90 - 110% (Stability); 95 -103% (Release)

Assay

Individual impurities: NMT 0.1%
Total Impurities:NMT 0.5%

Impurities

Meets USP

Content Uniformity

Dissolution

NLT 70% of labeled amount dissolved in 30 min :
(500 ml water; USP apparatus II {paddles}; 50 rpm)

NMT 100 CFU / tab total count
NMT 10 CFU / tab yeasts and molds

Microbiology

Figure 6.1 Example of a preliminary quality target product profile.