Plant Design and Manufacturing Principles - Coursework Example

Download file to see previous pages The paper "Plant Design and Manufacturing Principles" is a perfect example of finance and accounting coursework. This paper’s focus is on providing guidance on FDA’s needs regarding current good manufacturing practices. These practices are regarding processing, packing or holding. The holding is about the storage of pharmaceutical ingredients. The standards and requirements for APIs within the context of new drug application are described. The guidelines regarding the manufacture and control of drug and biologic APIs that are used in human and veterinary drug products are studied. The procedures and infrastructure needed for chemical isolation and purification processes for APIs are examined. This is for the construction of facilities that derive APIs from biological or fermentation processes. The facilities include sterilisation and aseptic processing.

This should be in accordance with CGMP regulations for finished pharmaceutical products. The identification of guidelines for CGMP manufacturing the APIs used in the manufacturing of drug products for clinical trials will be done. This is needed as the company is having a processing unit regarding the DNA vaccines. The practices that include validation of the processes that impact the quality and purity of the APIs are considered to be effective. It was recognised that the strictness in CGMPs regarding API production like written instructions, control of processes, sampling, testing, monitoring and documentation is compulsory and important. The steps from early to a final synthesis and purification stages are considered and the requirements in the facilities are listed and explained. The avoidance of adulteration practices also will be discussed. The standards followed and the infrastructure in the facility should maintain controls regarding the avoidance of adulteration.

• Requirements in Facility
  • Quality control unit

The most wanted unit in the facility will be the quality control unit. This should hold the responsibility and authority of approving and rejecting the raw materials and finished products. The packaging materials, labels and APIs also come under the purview of the quality control unit. 

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