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TRANSLATION PROBLEMS IN THE CONSTRUCTION PROJECT OF A
PHARMACEUTICAL PRODUCTION ENTERPRISE BASED ON GMP
STANDARDS
Maxamadjonov K.N.
Tashkent city, Institute of Pharmaceutical Education and Research, 3rd year
student, 301 group (I.P)
e-mail: kozimjonmaxamadjonov01@gmail.com, tel: +998 97 410 60 41
Yuldashev Sh.Z.
Tashkent city, Institute of Pharmaceutical Education and Research, Senior
teacher of the department social and humanitarian sciences.
https://doi.org/10.5281/zenodo.12663705
Annotation.
WHO defines Good Manufacturing Practices (GMP) as “that
part of quality assurance which ensures that products are consistently produced
and controlled to the quality standards appropriate to their intended use and as
required by the marketing authorization.”
Key words:
GMP, procedure, facility system, bioassays, categories
Aim.
GMP covers all aspects of the manufacturing process: defined
manufacturing process; validated critical manufacturing steps; suitable
premises, storage, transport; qualified and trained production and quality
control personnel; adequate laboratory facilities; approved written procedures
and instructions; records to show all steps of defined procedures have been
taken; full traceability of a product through batch records and distribution
records; and systems for recall and investigation of complaints.
The guiding principle of GMP is that quality is built in to a product, and not
just tested in to a product. Therefore, the assurance is that the product not only
meets the final specifications, but that it has been made by the same procedures
under the same conditions each and every time it is made. There are many ways
this is controlled - validation is that part of GMP that ensures that facility
systems, equipment, processes, and tests procedures are in control and
therefore consistently produce quality product. Validation is defined as the
establishing of documented evidence which provides a high degree of assurance
that a planned process will consistently perform according to the intended
specified outcomes. Validation studies are performed for analytical tests,
equipment, facility systems such as air, water, steam, and for processes such as
the manufacturing processes, cleaning, sterilization, sterile filling, lyophilization,
etc. There will be a separate validation for the lyophilizer as an equipment item
and for the lyophilization process; for the cleaning of glassware and the cleaning
of the facility; and for the sterilization process and for the sterility test. Every
DEVELOPMENT OF PEDAGOGICAL TECHNOLOGIES IN
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step of the process of manufacture of a drug product must be shown to perform
as intended. Validation studies verify the system under test under the extremes
expected during the process to prove that the system remains in control. Once
the system or process has been validated, it is expected that it remains in
control, provided no changes are made. In the event that modifications are
made, or problems occur, or equipment is replaced or relocated, revalidation is
performed. Critical equipment and processes are routinely revalidated at
appropriate intervals to demonstrate that the process remains in control.
A protocol is a written set of instructions broader in scope than a Standard
Operating Procedure (SOP). SOPs are the detailed written instructions for
procedures routinely performed in the course of any of the activities associated
with pharmaceutical manufacturing. A protocol describes the details of a
comprehensive planned study to investigate the consistent operation of new
system/equipment, a new procedure, or the acceptability of a new process
before it is implemented. Protocols include significant background information,
explain the rationale for and the objective of the study, give a full description of
the procedures to be followed, set out the parameters to be measured, describe
how the results will be analyzed, and provide pre-determined acceptance
criteria for making conclusions. Validation studies, stability studies, and clinical
studies are examples of written protocols for pharmaceutical manufacturers.
Validation protocols are important in ensuring that documented evidence is
taken which demonstrates that an equipment item, a system, a process or a
method consistently performs at a specified level. Validation of analytical assays
is the process of establishing one or more of: accuracy, precision, linearity,
range, limit of detection, limits of quantitation, specificity, and ruggedness as
appropriate to the type of assay. For physico-chemical methods there are
accepted defined limits for these test parameters. Bioassays are much more
variable in outcome and also often use animals and cells in the assay which in
themselves are variable, and can have broad acceptance limits. The discussion in
this guide is limited to bioassays. Bioassays. There are three broad categories of
bioassays which are commonly used for biological products: binding assays, cell-
based assays, and whole animal assays. Some complex assays are in more than
one of these categories. Binding assays are those that involve the binding of two
or more molecules. Immunoassays are an example of this type. Binding assays
are used for monitoring a molecule during purification steps and for cleaning
validations. Binding assays are not generally considered acceptable for potency
assays because the presence of a molecule as determined by a binding
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interaction is not necessarily an indication of the activity of the molecule. Cell
assays are those where the product evokes a measurable response in specific
cells: clumping, cell lysis, cell fusion, or generation of a specific detectable
chemical. These assays can be more variable than binding assays and must be
performed carefully to ensure consistent results. Cell-based assays are often
used for potency assays.
Conclusion.
Whole animal assays are more difficult and involve the care,
maintenance and handling of animals. They are time consuming and highly
variable. The biological response of an appropriate species to an active drug is
compared to the response to a reference product or to uninoculated controls as
a measure of activity. These assays are used for pyrogen assays, general safety
assays, and potency assays. Because of their expense, the large number of
animals used, the time spent, and their variability, whole animal assays for
potency are usually only performed for the final product release.
References:
1. Agalloco, J., "Points to Consider" in the Validation of Equipment Cleaning
Procedures, Volume 46, No. 5, PDA Journal of Pharmaceutical Science and
Technology, 2023
2. Austin P.R., Design and Operation of Pharmaceutical Bio-cleanrooms and
Aseptic Areas. Contamination Control Seminars, Michigan, 2024
