Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

Batch Formula

3.2.P.3.2

Day Capsules The following table gives the batch formula for a 150 kg pilot batch of bulk Day capsule product.

3.2.P.3.2.1

Formula Quantity/kg

Quality Standard

Raw Material

Paracetamol, fine crystal Phenylephrine Hydrochloride

128.00

Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur

1.57 6.42 7.50 1.52 0.77 2.31 1.54

Caffeine

Croscarmellose Sodium Sodium Laurilsulfate Magnesium Stearate

Maize Starch Purified Talc

TOTAL 150 kg A 150 kg batch size yields approximately 257,000 capsules.

The proposed maximum full-scale production batch size of Day capsules is 1000 kg bulk product. The following table gives the proposed batch formula for a maximum full-scale production batch of Day capsules.

Formula Quantity/kg

Quality Standard

Raw Material

Paracetamol, fine crystal Phenylephrine Hydrochloride

856.00 10.40 42.80 50.00 10.10 5.14 15.40 10.30

Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur Ph.Eur

Caffeine

Croscarmellose Sodium Sodium Laurilsulfate Magnesium Stearate

Maize Starch Purified Talc

TOTAL 1000 kg A 1000 kg batch size yields approximately 1,711,000 Day capsules. It is proposed that other suitably validated smaller batch sizes will be used up to the proposed maximum batch size of 1000 kg.