IntroductionThis 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 storage of the 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 construction of facilities that derive APIs from biological or fermentation processes.
The facilities include the 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 process 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 the API production like written instructions, control of processes, sampling, testing, monitoring and documentation are compulsory and important.
The steps from early to 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 FacilityQuality control unitThe 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. The raw materials and finished products should be fully investigated and resolved. The appropriate systems to ensure the investigation and authorisation should be established by the contractor building the facility. The unit should be responsible of the review and approval of the validation protocols. The changes in the product, process are determined while warranting the validation.
The quality control unit should pass on the responsibility and authority regarding the in process testing to the manufacture department. The processes regarding the release of intermediaries also should be delegated to the manufacturing department. The facility must be in such a manner to enable the employees to test the intermediates when they are in a isolated state. This type of infrastructure provided in the facility will save time on testing the intermediates. The principles and procedures regarding the quality control should be written form to make the employees follow them strictly.
The personnel involved in the production, processing, packing, holding or testing of an API and intermediate should have the education, training and experience or any type of combination of expertise should have relevant knowledge and practice regarding it. The number of personnel available to perform and supervise the above mentioned duties should be in sufficient number. The management should maintain the number of personnel not less than the sufficient number recommended by the specialist committees.