Pharmaceutical Processing: Guidelines and Quality Assurance

Running head: PHARMACEUTICAL PROCESSING
PHARMACEUTICAL SCIENCE
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1PHARMACEUTICAL PROCESSING
Answer 1
A.
The Q7 Good Manufacturing Practice guidelines was prepared to standardize the process
of preparation of active pharmaceuticalingredients and it also determines the quality and purity
of the active pharmaceutical unit within a pharmaceutical production unit (ICH Q7 Guideline
2018). According to this guideline, manufacturing process is inclusive of receiving raw
materials, production of the pharmaceutical units, packaging, labeling, quality control, release
storage and distribution, therefore, this guideline recommends several steps throughout these
abovementioned processes to standardize the process and increase the quality and purity of it.
This section will review the entire Q7 GMP guideline and then will determine the requirements
as per the guidelines (ICH Q7 Guideline 2018).
While reviewing the guidelines, several aspects are primary concerns such the quality
management process, the location of building and the facilities available, the working personnel
and their level of hygiene should be discussed. Further process documentation, material
management, and production, packaging, labeling and other important steps are also included in
the guidelines (Wuchter et al. 2015). In this guideline, the quality management process is
mentioned as independent from production. This is an important aspect as independent quality
management department helps to maintain quality and take un-bias decisions within the
organization structure. As while production, millions of costs are investment, absence of
independent quality department will tend to allow the poor quality pharmaceutical product,
otherwise the company would face a huge loss (Lee et al. 2015). Therefore independent quality
management system determines honest ad appropriate batch release. Further the guidelines also

2PHARMACEUTICAL PROCESSING
determine that the other departments such as raw material testing, labelling and testing. Further
the guideline also determines that sampling process should be carried out by departments other
than quality control department. Therefore, while reviewing it was clear that the guideline is
inclusive of recommendations that enhance the quality of the service (ICH Q7 Guideline 2018).
However, in quality management area, there are several aspects that should be mentioned
in the guidelines. Firstly, according to the guidelines, other departments such as raw material
testing, product (raw material) receiving department and others are allowed to perform sampling
process and are allowed to allow the material for the production. However, the guideline did not
provided any regulation so that the quality control department can cross check the reports of
these departments. Further, the finishing product is completely dependent on the quality of the
raw material (Lee et al. 2015). Hence, if the quality control department does not follow the
sampling and raw material testing, it will be difficult for the quality control department to
understand the finished product quality and perform API release testing. Further, the guidelines
discussed about internal audits so that the mistakes within the system can be highlighted and
proper corrective action can be taken. However according to (), corrective action should always
be followed by preventive action so that such mistake can never occurs again. This should also
be included within the Q7 good manufacturing practice guidelines in quality management area
(Wuchter et al. 2015).
B.
While quality management is an integral part in the pharmaceutical manufacturing
process, maintenance of the management process and the entire system is also important if the
quality of the product is concerned. Quality assurance is the process that determines the