The objective of the implementation of these guidelines is to ensure the quality and integrity of the starting material and the pharmaceutical product.
The guidelines should be considered and implemented inter alia by suppliers, such as:
- pharmaceutical manufacturers, including manufacturers of intermediate and/or finished products;
- manufacturers of pharmaceutical starting materials;
- brokers; and
- other suppliers.
They are also relevant to:
- regulatory bodies;
- international organizations and donor agencies involved in procurement tenders;
- relevant trade organizations;
- certifying bodies; and
- all parties involved in trade and distribution.
Member States should take appropriate measures to ensure the implementation of these guidelines. The guidelines can be used as one tool in the prevention of the trade in counterfeit and substandard medicines.
The importance of quality of the pharmaceutical starting materials used in the manufacture of pharmaceutical products cannot be over-emphasized. The marketing authorization dossier for a finished product should normally refer to the use of a pharmaceutical starting material from a specific source(s) in that product. The sourcing, storage, distribution and use of these starting materials are thus a shared responsibility.
The role of the producer, manufacturer, trader, broker or distributor in sharing the responsibility for a quality product is evident. Each must ensure that materials are of the quality required for use in the pharmaceutical industry, as each plays an important part in the manufacture and supply chain to ensure that a quality product is supplied to the patient.
For this reason, materials can only be reclassified from pharmaceutical grade to non-pharmaceutical grade and not from non-pharmaceutical grade to pharmaceutical grade.
Each batch of pharmaceutical starting material should normally be tested by its manufacturer for compliance with its specification. When results are obtained from skip lot testing this should be indicated on the Certificate of Analysis issued by the manufacturer.