الفهرس 
GENERAL INTRODUCTION
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Abstract
The thesis deals with an analytical study on drug residues likely to contaminate the
”next product” on the manufacturing line.
The thesis comprises three parts:
Part I
This part is an introduction to general principles of validation of cleaning procedures in
pharmaceutical industry. The introduction began with the importance of analysis of drug residues
in constructing cleaning validation protocols. Next, the definition and importance of cleaning
validation were briefly discussed. Steps needed to develop an efficient cleaning validation
protocol were discussed in details.
The thesis deals with the validation of cleaning procedures used to clean equipments
used in the manufacture of small volume parentrals.
The thesis contributed in the cleaning validation program through:
1. The choice of worst case product.
2. The calculation of maximum level of drug residue allowed to be present on
equipment surface after cleaning process.
3. Choice of analytical method suitable for analysis of target residue at and below
the accepted level.
4. Applying recovery studies to assess the efficiency of sampling procedures to
collect target residue from equipment surface.
5. Validation of analytical method used for analysis of target residue in after
cleaning samples.
Part II
This part deals with the choice of a worst-case product to represent all products
manufactured on the same production line for the purpose of cleaning validation. Criteria used
for worst case selection included solubility and potency of active pharmaceutical ingredient, type
of formula and the frequency of manufacturing. By combining all the above mentioned criteria,
Amri-K® was considered as the worst case product to represent all products manufactured on
small volume parentrals manufacturing line. Analytical study was carried out on Amri-K®,
Meloxicam® and Vinporal® in order to practically find the residue most difficult to be removed
from equipment surface.
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