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As per available reports about, 178 Conferences, 166 National Symposiums are presently dedicated exclusively Parenteral manufacturing procedure and about 2 articles are being published on Parenteral manufacturing procedure.
Parenteral preparations are sterile preparations containing one or more active ingredients intended for administration by injection, infusion or implantation into the body. They are packaged in either single-dose or multidose containers.
The manufacturing process should meet the requirements of good manufacturing practices (GMP). The following information is intended to provide broad guidelines concerning the main steps to be followed during production.
The quality and grade of starting materials, the design and maintenance of the equipment and the method of manufacture must be such as to ensure the stability of the active substance and of the final product and that the final product is sterile and free of pyrogens and particulate matter.
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Scope and Importance:
Most GMP guides for API’s do not provide specific guidance on the manufacture of sterile API’s. This CEFIC document provides this additional guidance which is unique to the manufacture and handling of sterile APIs. The manufacture of API intermediates used in sterile processes falls outside the scope of this document and is covered by general GMP guidelines for API’s such as the CEFIC document “GMP guidelines on manufacture of Bulk Pharmaceutical Chemicals” dated August 1996. As with all CEFIC documents, this guidance document has been written to assist industry in certain aspects of manufacturing under the GMP regime.
It is considered a general GMP requirement that the manufacture of all intermediates and API’s should be carried out under conditions that minimise the risk of contamination by the manufacturing environment. Manufacture of sterile API’s should take place in equipment, designed to be easily operated, cleaned and sterilised by personnel trained in performing aseptic processes. Clean room classifications are defined in the Addendum to this document. Whenever the process is open and the sterile API is exposed, this should be within a grade A area or in a grade A local workplace with a grade B background. The standards for equipment design and environmental control required for the manufacture of sterile API’s are been described in chapter 6 of this document. Sterile API’s can be manufactured by terminal sterilisation or by aseptic processing; terminal sterilisation is the method of choice. The two techniques are described in more detail in chapter 8 of this document.
During development the effectiveness of any antimicrobial preservative present in the preparation shall be demonstrated to the satisfaction of the relevant regulatory authority.
Heating in an autoclave (steam sterilization) is the method of choice for aqueous preparations and should therefore be used whenever possible.
When a parenteral preparation is liable to deterioration due to oxidation the operation of filling may be performed in an atmosphere of suitable sterile inert gas, such as nitrogen, whereby the air in the container is replaced by this gas.
In the manufacture of preparations containing dispersed particles measures are taken to ensure a suitable and controlled particle size with regard to the intended use.
In the manufacture of liquid preparations measures are taken to ensure that the volume of the preparation in the container is sufficient to permit withdrawal and administration of the nominal dose using a normal technique.
The global market for contract pharmaceutical manufacturing, research and packaging totaled $248.5 billion in 2014 and is projected to approach $352.8 billion by 2019, registering a compound annual growth rate (CAGR) of 7.3% through 2019.The global market for ADC drugs reached $179 million in 2012 and $396 million in 2013. The market should reach $2.8 billion in 2018 with a compound annual growth rate (CAGR) of 48.1%.
International symposium and workshops:
Relevant Society and Associations:
This page will be updated regularly.
This page was last updated on 11th Sep, 2015
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