In the pharmaceutical and life sciences industries, a sound supplier qualification program is a must. It is an indispensable element of their very reputation. Many pharmaceutical organizations contract several of their manufacturing processes or even products to third parties. For this reason, the FDA considers the supplier as a logical extension of the manufacturer. In fact, it attaches so much importance to this area that it holds the pharmaceutical organization (the contracting company) responsible for the supplier’s behavior in relation to the manufacturer’s product
The FDA can inspect the supplier’s facility too
Since the supplier is considered a part of the manufacturer’s operations, the FDA reserves the right to inspect the supplier’s facility too, at the time of carrying out an inspection of the pharmaceutical organization. This being the importance of the supplier, it is imperative to chalk out an effective supplier qualification program that meets regulatory requirements.
A supplier qualification program starts with supplier evaluation. Obviously, the supplier and his facilities have to be inspected according to predefined parameters. This will enable the pharmaceutical organization to clearly state the terms of the contract. The contract should ideally specify the conditions in which the pharmaceutical product is going to be made.
Key elements of a sound supplier qualification program
All the important aspects of a supplier qualification program have to be put in place, as should the kind and nature of control. There should be proper checking up of data that goes into the supplier qualification program. These are some of the aspects that need to be implemented:
- Establishment and maintenance of data that clearly describe or reference the specified requirements, among which quality requirements are very important
- Identification of the key elements of a strong, sustainable and successful supplier qualification program
- Signing of terms of the contract and making written agreements of the same, in which all the conditions of work will be clearly specified and ensure that the supplier meets the quality requirements consistently
- Ensuring that the supplier qualification program has processes that are important to quality. This should also define how conformance to manufacturer requirements will be monitored and verified.
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