Gentian violet solution 0,5% Batch quantity 1000 ml Master manufacturing formula

approved by
Prepared by:
Preparation date: Source master manufacturing
Batch number: formula: Dermatological preparations
for the tropics, 2nd ed.

Raw materials and packaging materials

Quantity Source and batch Actual quantity Initials weighing Initials control
prescribed number weighed/measured
Gentian violet 5g
Water to 1000 ml

Properly closing bottle(s) or

container(s)

Preparation In-process checks

1. Boil 1200 ml water for 1 minute and allow to cool. Use this water for the preparation. Water boiled? yes/no
2. Dissolve the gentian violet in 1000 ml of this water. Check for undissolved crystals on the bottom of Completely yes/no
the flask. dissolved?
3. If dissolution is incomplete continue shaking until the crystals have completely dissolved. Completely yes/no
dissolved?

2012 jfmamjjasond 2013 jfmamjjasond 2014 jfmamjjasond 2015 jfmamjjasond 2016 jfmamjjasond 2017 jfmamjjasond

Storage condition in properly closed containers between Yield

15 ° and 30 °C
Shelf life 3 months Loss
Expiry date Loss due to

End controls before release of batch Checked by Result

Batch numbers raw materials correct?
Packaging materials correct, in good condition and closed properly?
Labelling conform model?
Expiry date stated correctly?
Completely dissolved?
Are all boxes on this form filled correctly and completely?

Batch released by (name and signature) Date:

Model of label for stock Model of label for the patient

For external use only For external use only
Gentian violet solution 0,5% Dispensing unit and date
Batch number and batch date Gentian violet solution 0,5% _______ ml
Do not use past: (production date + 3 months) Patient name
Store in properly closed containers between 15 °C and Clean affected area and apply to affected area only. Leave
30 °C. exposed, do not cover. Do not swallow.
Do not use past (dispensing date + 1 week)