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SOP for Cleaning Validation Prior to Product Change Over

OBJECTIVE
To lay down a procedure for Cleaning validations prior to product change over.

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
The Quality Control Chemist is responsible for implementation of the process.
The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE
  • The container or equipment to be checked is rinsed with distilled water and an aliquot of the liquid is taken for analysis. The container / equipment is free from previous product if the result is negative. If the result is positive further cleaning is necessary.
Tests
Aspirin Tablets to any other product.
  • To about 30ml of the sample add 30ml 2N HCl. Heat on a water bath for 30 minutes, cool and add 10ml of ferric chloride solution.
  • The test is positive if a violet colour develops.
Chloramphenicol capsules to any other products.
  • To about 25ml of the sample, add 5ml of ethanol, 10ml of 1M sulphuric acid and100 mg of zinc powder. Shake and allow it to stand for 10 minutes. Cool in ice and add 2ml of sodium nitrite.
  • Shake and keep for 2 minutes. Add 2g of urea. Shake to dissolve, and then add 2ml of 2-naphthol solution followed by 5ml of 10M sodium hydroxide.
  • The test is positive if a red colour is produced.

Chloroquine Phosphate Tablets to any other product.
  • The sample is diluted with HCl to have a 0.01M HCl solution. Measure the absorbance of the resulting solution in the range of 300nm to 360nm. If there is any absorbance maxima at 343 and 329 find the ratio of ABS 343 / ABS 329.
  • The test is positive if the ratio is between 1.0 to 1.5
Indomethacin capsules to any other product.
  • To about 25ml of sample add 2ml of 2M sodium hydroxide
  • Test is positive if a bright yellow colour is produced.
Metronidazole tablets to any other product.
  • To about 10 mL of sample, add 10mg of Zinc powder, 2ml of HCl and allow it to stand for 5 minutes. Cool in ice and add 1ml of sodium nitrite solution. Keep for 3 minutes; add 2ml of 3% Ammonium sulphamate solution and shake. Then add 1ml 2-naphthol solution followed by 2ml of 5M sodium hydroxide.
  • The test is positive if an orange colour is produced.
Tetracycline Hydrochloride Capsules to any other product.
  • To about 20ml of sample add 20ml of warm ethanol. Allow to stand for 20 minutes, filter and evaporate the filtrate to dryness on a water batch. To the residue add 2ml of sulphuric acid.
  • Test is positive if a deep crimson colour is produced. On addition of 1ml of water the colour changes to deep yellow.
Paracetamol Tablets to any other product.
  • Boil about 50ml of sample with 5ml of HCl for 3 minutes and cool; no precipitate should be produced. Add 0.25ml of 0.0167M potassium dichromate:
  • Test is positive if a violet colour is produced slowly which does not turn red.
Note: This is example for other products, see identification test.

REFERENCE(s)
Nil.

ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.A Quality Assurance
No. Number
Q.C Quality control
mg Milli gram
gm Gram
ml Milli liter
HCl Hydrochloric acid
M Molar

ANNEXURE(s)
Nil.


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