Report on Good Distribution Practice for Pharmaceutical Products

This report delves into the critical aspects of Good Distribution Practice (GDP) within the pharmaceutical industry. It emphasizes the importance of GDP as a regulatory framework ensuring the quality and safety of pharmaceutical products throughout the supply chain, from manufacturing to storage and distribution. The report specifically examines Good Manufacturing Practice (GMP) of pharmaceutical products, outlining key guidelines such as quality management, sanitation, facilities, equipment, raw materials, personnel training, validation, complaint handling, documentation, inspections, and audits. Furthermore, the report details the crucial guidelines for the storage of pharmaceutical products, including storage area design, security, environmental considerations, cleanliness, space allocation, ventilation, lighting, pest control, and the prohibition of certain items within storage areas. The report underscores the importance of adhering to these regulations to maintain product integrity and patient safety. It concludes with recommendations for organizations to follow government regulations and maintain proper hygiene standards, highlighting the significance of GDP in the pharmaceutical industry.

Reading Head: GOOD DISTRIBUTION PRACTICE 0
Psychology
April 11
2020

GOOD DISTRIBUTION PRACTICE 1
Contents
Introduction................................................................................................................................2
Goods Distribution Practice.......................................................................................................2
Good Manufacturing Practice of Pharmaceutical Products....................................................2
Storage of Pharmaceutical Products.......................................................................................4
Recommendations......................................................................................................................5
Conclusion..................................................................................................................................6
References..................................................................................................................................7

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Introduction
Good distribution is considered to be that practice in which the government has set some
regulatory guidelines that help in governing the wholesale distributors of the product. This
practice is considered to be an essential part. It is because it is concerned with the quality
assurance. This practice will help in ensuring the quality of pharmaceutical products. It is
very important to maintain the quality of these products as they are concerned with the health
of the people. Many activities are involved in the goods distribution process. This process
includes manufacturing, storage, transportation, import and handling activities (bsi., 2020). In
this discussion, the main focus will be on two factors of good distribution practice. These
factors are Goods manufacturing practices and storage of pharmaceuticals products.
Goods Distribution Practice
Goods distribution Practice is considered to be an essential element that helps in evaluating
quality assurance. Therefore it is required by every company to initiate a quality system that
ensures that products are properly stored and handled. Certain appropriate conditions are
been required in the organizations (HSA, 2019).
Good Manufacturing Practice of Pharmaceutical Products
This is considered to be the system that helps in ensuring the manufacturing of
pharmaceutical products. The products that are included in this category are food, cosmetics,
and pharmaceutical products. All these products need continuous process and quality should
also be maintained. Some regulations are implemented by the government to maintain the
quality of the products. These regulations are implemented by manufacturers all over the
world. These are also considered to be essential regulations that can regulate the
manufacturing, verification, and validation of products (Focused Pharama Engineering,
2020). Twelve basic guidelines are have followed by the companies in Singapore. These
guidelines are as follows:
 Quality Management
The principle of quality management is used for ensuring that the products are safe to use and
it will fulfil the requirement of patients. It will also ensure that there is no risk in consuming
these products. The factors that are used in this principle are quality assurance, quality
control, GMP for product and risk management (integrating GMP, 2005).

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 Sanitation and Hygiene
It is considered to be an important aspect in the manufacturing of products. This factor ill
prevent products from getting contaminated by personnel, environment, infrastructure and
production material. The company should eliminate the risk of contamination (Safety Culture
, 2020).
 Facilities
The manufacturing operations of the company should be located in an environment that is
suitable for the manufacturing of goods. Premises should be designed in such a way that it
will reduce the chances of errors (Safety Culture , 2020).
 Equipment
Equipment that is necessary for the productions of goods should be available in the company
and they must be clean and safe to use. They should also be stored in a safe place. Defective
tools should be labelled. So that it will not be used in operations (ECA Academy, 2020).
 Raw Material
The raw material is the basic component to manufacture goods so it should be kept in suitable
conditions. Proper stock management should be implemented in the company. Quality of raw
material is very important because then only quality of final products can be maintained
(Safety Culture , 2020).
 Personnel
Employees of the organization are very important and therefore they should be effectively
trained. Employees should also be aware of the guidelines of the government. Hygiene
should also be maintained among employees. Proper training should also be given to
employees so that they can also follow guidelines effectively (Safety Culture , 2020).
 Validation and Qualification
Quality systems and tools should fit and validate the process that can produce high-quality
products. The company should take several steps to ensure the quality of the product.
Qualification and validation should provide proper documentation (Pharama Tech., 2020).
 Complaints

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It is very important for companies to handle the complaints and therefore it is required by all
the companies to have a proper complaint system. Complaints provide feedback to
companies so that company can improve their shortcomings. Therefore complaints should be
managed properly (Safety Culture , 2020).
 Documentation and Recordkeeping
The quality assurance system is an important part. It is very important to maintain accurate
recordkeeping and documentation so that records can be tracked easily. Documents must be
clear and effectively managed (Safety Culture , 2020).
 Inspections and Quality audits
Inspection of products should be done on a regular basis. It should be evaluated that what
documents are required to take corrective measures and improvement. Quality audits are
done to evaluate the quality systems that are implemented by the company (Safety Culture ,
2020).
Storage of Pharmaceutical Products
Some guidelines have to follow the companies to store their goods. These guidelines are as
follows:
 Storage areas of the companies should be designed in such form that it will ensure
that required conditions that are required to store the products are met. There should
be proper security in the storage area (Health and Science Authority, 2015).
 Products should also store in such an area that will not get affected because of the
weather conditions. Before putting products in storage area products should be clean
(World Health, 2014).
 There should be enough space available in the storage area so that similar products
should be kept together. The storage area should be market properly and rejected and
damaged products should also be kept separately (Health and Science Authority,
2015).
 There should be proper ventilation and lighting available in storage areas. This will
ensure safety while operating with those products (Policy and economc issues, 2011).
 The storage area should be clean and dry. There should be proper methods of cleaning
undertaken so that it will ensure the safety of the product and it will also save
products from getting damaged (Health and Science Authority, 2015).

GOOD DISTRIBUTION PRACTICE 5
 Proper inspection of cleanliness should be done by managers of the storage place.
Pallets should be maintained and kept in good condition.
 Storage conditions should be mentioned on the label of the product. All the products
that are manufactured by the company should follow their storage requirements.
There should be cameras installed in the storage area so that relevant reading and
recordings can be extracted. Appropriate actions should be taken by the company
(Health and Science Authority, 2015).
 The cameras that are managing conditions of storage should also be kept in
appropriate surroundings. These instruments should also be calibrated after a fixed
period. Calibration of these tolls should be connected with national or international
standards.
 Products that are dangerous such as liquids, gases, solids should be stored in well-
equipped and designed storage areas. Because these products are at high risk and they
can result in hazardous situations (Health and Science Authority, 2015).
 The storage areas should be designed in such a way that it is prevented from insets or
animals. The proper pest control program should also be initiated by the company at
fixed intervals. Record of pest control should also be maintained.
 Products that are for personal use such as food, drinking, smoking, and other medical
products should be prohibited in storage areas. There are chances that it can harm
products and cleanliness of storage areas will also be spoiled (Health and Science
Authority, 2015).
Recommendations
It is recommended to every organization to follow the rules that are set by government. These
rules and guidelines are set so that the products that are produced and manufactured by the
company will not be damaged because of the any reason. Every company should make a
cleanliness chart in which they have to mark cleanliness done for the day. It is also
recommended for companies to maintain proper hygiene in the company. Employees should
also be aware of the guidelines and they are also responsible to take proper hygiene measures.
Conclusion
Pharmaceuticals products are highly sensitive and they are directly related to the consumption
of people. These products should be kept and distributed properly. Some guidelines are set by

GOOD DISTRIBUTION PRACTICE 6
the government so that the quality of products can be maintained. Every country has a set of
rules and regulations. Goods manufacturing products and Storage of product guidelines are
mentioned above. These are all necessary guidelines that are necessarily followed by
Pharmaceuticals Company.

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References
bsi.. Good Distribution Practices. 04 15, 2020, Retrieved from:
https://www.bsigroup.com/en-IN/gdp-for-pharmaceutical/
ECA Academy. (2020, 10 06). GMPs for Equipment, Utilities and Facilities. Retrieved from
https://www.gmp-compliance.org/training/gmp-course-conference/gmps-for-
equipment
Focused Pharama Engineering. (2020). Good manufacturing practice. Retrieved from
https://www.nne.com/services/good-manufacturing-practice/
Health and Science Authority. (2015, 08). Storage of pharmaceutical products. Retrieved
from https://www.hsa.gov.sg/docs/default-source/hprg-ald/guide-mqa-013-010.pdf
HSA. (2019, 10 04). Good Manufacturing Practice and Good Distribution Practice
Standards. Retrieved from
https://www.hsa.gov.sg/chinese-proprietary-medicines/dealers-licence/gmp-gdp-
standards
integrating GMP. (2005, 09). Quality Management System. Retrieved from :
http://academy.gmp-compliance.org/guidemgr/files/1943.PDF
Pharama Tech. (2020). Qualification, Validation, and Verification. Retrieve, from:
Qualification, Validation, and Verification
Policy and economc issues. (2011). Managing Distribution. Retrieved from
https://www.msh.org/sites/msh.org/files/mds3-ch22-distribution-mar2012.pdf
Safety Culture . (2020). Good Manufacturing Practices: What You Need to Know. Retrieved ,
from : https://safetyculture.com/topics/gmp/
World Health. (2014). Design and procurement of storage facilities. Retrieved from
https://www.who.int/biologicals/expert_committee/Supplement-2_TS-warehouse-
design-ECSPP-ECBS.pdf

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