APIs from Legitimate and Reliable Sources|Procurement of GMP compliant APIs

Writer:PROSPECT CHEMICAL LISource:APIs from Legitimate Date:2017-08-24
1. Introduction  
Counterfeit and sub-standard APIs are increasingly present. Not only are they a fact of non-compliance but also they form a serious and increasing risk for patient safety. Various initiatives have been taken such as the founding of the FDA Counterfeit Drug Task Force, the European Commission’s current “Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use” and the WHO Program “IMPACT” (International Medical Products Anti-Counterfeiting Taskforce).  现在假药和劣药日益增多。 
This document focuses on the interaction between the API manufacturer and the medicinal product manufacturer and provides possible measures that may be taken by both partners in order to ensure only non-rogue APIs are used in the manufacture of medicinal products. The proposed measures are considered as elements out of a whole puzzle. A risk-based approach should be applied to determine the necessity and value of the individual proposals, alone or in combination.   
The document does not address in detail the vendor qualification process as it is taken for granted that APIs are only purchased from suppliers that have been thoroughly evaluated and approved by Quality Assurance in line with GMP requirements.   
2. Supply Chain Agents, Brokers, Distributors, Repackers, Relabelers  
As a general principle, the shorter the supply chain, the more secure it will be. This is reflected in the EU GMP Guidelines, Part 1 (5.26) specifying that starting materials (APIs, excipients) should be purchased, where possible, directly from the producer.   
In addition to the length of the supply chain, any changes on the original container – e.g. by repackaging, relabeling – should be considered as an additional risk for alteration and should therefore, whenever possible, be avoided.   
There is no doubt that the entire supply chain needs to be assessed from a quality perspective, covered by an effective supplier qualification program and the same principles as described in the following sections for the direct supply form API manufacturer to drug product manufacturer should be applied.  
This already starts at the point of selecting the contractor for transportation of the API  (see also ICH Q7, 10.23).   
3. On Site Visits Audits  3.1. Visits  
A thorough knowledge of the supplier is a key element. Therefore, a close and stable relationship between the manufacturer of the API and the drug product manufacturer should be achieved by using various means of contact. A regular exchange between sourcing-and purchasing people and the supplier contributes to strengthening this relationship, especially if the contact also includes 

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Keywords for the information:Procurement of GMP compliant APIs 

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