Pharmaceutical Processing: Guidelines and Quality Assurance

This article discusses the Q7 Good Manufacturing Practice guidelines and quality assurance process in pharmaceutical processing. It covers the importance of quality management and documentation process in drug manufacturing. It also explores non-compliance issues and drug investigations. The article provides insights into warning letters issued by the FDA to non-compliant drug manufacturing companies. It also discusses the investigation process carried out by the Health Products Regulatory Authority.

Running head: PHARMACEUTICAL PROCESSING
PHARMACEUTICAL SCIENCE
Name of the Student
Name of the University
Author note

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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

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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

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effectiveness of the guidelines within an organization that produces lifesaving drugs throughout
the world (EUDRALEX 2018). The quality assurance process requires different specifications,
documents and instructions that determines the standard of any process. according to the (), the
documents that are necessary for a complete quality assurance protocol are specifications,
manufacturing processing, production, packaging and testing instructions, technical agreements,
protocols report, records and certification of analysis. These specifications are present for raw
materials to dispatch of finished goods. Furthermore, it is inclusive of packaging materials, batch
processing and batch packaging records as well as intermediate and bulk productions
(EUDRALEX 2018).
However, while reviewing the documentation process for departments like quality system
to self inspection, there were several sections there are several aspects for which the guideline
should be reviewed so that minimal error can be encountered. The first and very important aspect
was hand written documents. There is a high chance of human errors while documenting hence,
the entire documentation process should be computer based so that human made error can be
nullified (Zbrozek et al. 2013). Further, duplication and back dating documentation is another
factor that hampers the quality assurance process. Hence, such system should implemented
through which any certification of analysis can be generated only once in the system and the
quality assurance department will authorize the specific department to use that COA for further
analysis. Hence, maintenance of quality within the production will become more compact
(Marshall et al. 2016).

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Answer 2
To determine the non-compliance of a production or manufacturing unit to that of the
FDA guidelines, the warning letter of FDA to Labocant Industrial SRL has been chosen. The
Labocant Industrial SRL is a drug manufacturing unit in the Dominican Republic and this
warning letter was issued by the FDA or Food and Drug Administration. The administration
visited the drug manufacturing unit situated in Entrada Zona Franca, La CaletaAutopista Las
Americas, Km 19 Santo Domingo, from June 5 to 9, 2017 (FDA 2018). After complete analysis
of the warning letter provided by the FDA to the drug manufacturing company it was determined
that the organization was unable to comply with the current good manufacturing practice or
cGMP process and the violation was based on the 21 SFR, part 210 and 211. Further according
to FDA, the company’s methods, controls and facilities for the manufacturing, process, packing
and dispatching is found to be non-compliance with the cGMP practice (FDA 2018). Further the
drug is also found to be adulterated that violated acts such as 21 U.S.C. 351(a)(2)(B) and the act
of federal food and drug. Hence, the warning letter was assigned for the company. Further the
company reviewed their process and asked the FDA to revisit their production unit however, still
there were several faults as the company failed to confine their production to a specific area and
was failed to prevent mix ups of the raw materials and prevent contaminations. Secondly the
organization was unable to comply with the laboratory records and was not being able to show
all the data of the reports and related standards (Nguyen et al. 2013).
The non-compliance described by the healthcare unit is much more appropriate as the
company was not being able to control contamination of the raw material that could eventually
affect the finished product (Yim and Chung 2014). Further, non-compliance with cGMP is also
an important aspect as it is important for organizations to implement as it determines the quality

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and purity of the production process. Therefore, the warning letter due t non-compliance to these
quality aspects is justified.
A snapshot and link of the letter has been provided in this section.
The link:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm601181.htm
Answer 3
There are several drugs that are under control and control due to the excessive usage and
are under investigation. This investigation was named as the quality defect investigation and was
conducted on the basis of reporting and information gathering (ICH 2018). The drug, which is
under investigation, is lanivudile clonemel. This investigation was based on online approaches.
The subjects that are eligible for reporting process are the number of affected batches, affected

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distribution related details, no of affected batches received by the retailer and so on. The online
reporting system was developed for the healthcare professionals so that they can call for
investigation if they found any abnormality in the dose of drug they provide to the patient
(Rognoni et al. 2014). Further the EU good manufacturing guide also certified several
individuals to carry out investigation regarding drug so that prior to importation and exportation
of controlled drug the proper detailed investigation report can be generated (Alsante et al. 2014).
These importing and exporting guidelines are associated with the compliance guidelines that
each manufacturing company have to follow in order to dispatch their products in the market.
The organization that is assigned to carry out these investigation is the HPRA that provides
consisted and efficient process so that drug related investigation can be completed without any
delay (ICH 2018). The quality management of the organization are able to achieve the goals
regarding the drug as it includes each aspect starting from physiological process, financial
approach and effect on legislations so understand the effectiveness and safety as well as purity of
the drug. Therefore, after reviewing the drug investigation process in the Health Products
Regulatory Authority it is clearly determined that the authority undertakes investigation on drug
and medicinal products that did not provide proper and authentic result of not affecting any
person with its composition, production process and storage techniques (ICH 2018). Further, the
drugs, which are over used by the healthcare facilities without checking its excessive effects on
people, are also taken under investigation process so that the effect of overdose can be
determined.

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References
Alsante, K.M., Huynh-Ba, K.C., Baertschi, S.W., Reed, R.A., Landis, M.S., Furness, S., Olsen,
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FDA 2018. Warning Letters. [online] Fda.gov. Available at:
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ICH 2018. Quality Guidelines : ICH. [online] Ich.org. Available at:
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2018].
ICH Q7 Guideline 2018. ICH Q7 Guideline: Good Manufacturing Practice Guide for Active
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