Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

Night Capsules The following table gives the batch formula for a 143.6 kg pilot batch of bulk Night Capsule product.

3.2.P.3.2.2

Formula Quantity/kg

Quality Standard

Raw Material

Paracetamol, fine crystal Phenylephrine Hydrochloride Croscarmellose Sodium

128.4.00

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

1.57 7.50 1.52 0.77 2.31 1.54

Sodium Laurilsulfate Magnesium Stearate

Maize Starch

Talc

TOTAL 143.6 kg A 143.6 kg batch size yields approximately 257,000 capsules.

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

Formula Quantity/kg

Quality Standard

Raw Material

Paracetamol, fine crystal Phenylephrine Hydrochloride Croscarmellose Sodium

894.00 10.90 52.2 10.60 5.37 16.1 10.7

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

Sodium Laurilsulfate Magnesium Stearate

Maize Starch

Talc

TOTAL 1000 kg A 1000 kg batch size yields approximately 1,780,000 Night capsules. It is proposed that other suitably validated smaller batch sizes will be used up to the proposed maximum batch size of 1000 kg.