Dear Zuriash,
I hope it is not too late to respond on this. My colleague Michelle has provided this response.
The European perspective:
According to the European Pharmacopoeia,
During development, it must be demonstrated that the nominal content can be withdrawn from … single-dose containers.
In other words, an appropriate overfill (distinct from an overage) must be determined during product development. This is only stated explicitly for single-dose containers.
Manufacturers may opt to put the voluntary ℮ (estimated) symbol on products between 5 ml (or 5 g) and 10 litres (or 10 kg) in volume (or mass). This is applicable to all kinds of products – medicines, foodstuffs, cosmetics etc. By putting the symbol on the pack, the manufacturer is guaranteeing that the product meets the requirements of the EU rules on nominal quantities for prepacked products i.e. the average quantity of product in a batch is not less than the label claim, and the batch complies with negative error limits.
Products not bearing the ℮ symbol must meet the metrology regulations of each individual EEA country in which they are marketed. Opting for the symbol therefore reduces complexity.
Although overfilling is permitted, excessive overfills are of course undesirable from a manufacturer’s point of view because they represent extra costs.
Hopes this helps to clarify.
Kind regards
Karen
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Karen Real
Director
Real Regulatory Ltd
London
United Kingdom
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Original Message:
Sent: 08-19-2015 16:05
From: Zuriash Berhe
Subject: Allowable Excess volume for oral solutions
Dear All,
Does anyone know if there is a guidance for allowable excess volume for oral solutions. I know there is a guidance for injectable products but I couldn't find for oral solutions.
Thanks in advance for your help
Zuriash
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