1.0 OBJECTIVE
One of the most critical aspects of dosage from manufacture is the vigilance and care required ensuring the complete absence of any form of cross contamination. Detailed hereunder are the different controls at the various stages:
2.0 PURPOSE
v This standard operating procedure outlines the proper procedure to check the cross contamination in the best possible way.
3.0 SCOPE
v It is applicable in the Raw Material Store, Finished goods store, Production departments.
4.0 RESPONSIBILITY
v Warehouse Incharge
v Production Manger
v Section Incharge
5.0 PROCECUREMENT
1 The purchase and quality control personnel conduct a systematic vendor evaluation.This includes a detailed inspection of the suppliers factory, the main purpose of which is to identify any potential source of cross contamination of substances supplied.
2 If the manufacturing location is manufacturing more than one item, periodically the QC department will attempt to identify the presence of the contaminant in the item purchased.
3 The procedure followed in the production of packing components, particularly the intimate packaging items ( tubes , vials, laminate ) is carefully studied by the QC team, essentially with a view to track any residual contaminant e.g. mould lubricant, metal filling etc.
6.0 RECEIVING AND STORAGE
4 The staff responsible for clearing and forwarding are “educated “on the importance of inspecting the cargo to identify if there is any evidence of contamination.
5 There is a very strong possibility of improper storage , whereby, material purchased is accidentally contaminated by the contents of other customs hold area.
6 A similar vigilance is required to exercised by all personnel responsible in the company for storage at different stages/locations. Periodically the statutory agencies, particularly the import control department requires samples to drawn.
7 Unless these samples are drawn carefully in QC personnel for such sampling.
8 The stores personnel will verify with QC suitability of containers if the contents from the original
7.0 DISPENCING
v The SOP for dispensing of materials needs to be religiously followed to prevent any cross contamination.
8.0 COMPOUNDING
v Apart from the prescribed SOP,s supervisors concerned will pay attention to the condition of garments worn by the operators and cleanliness of the various accessories, including scoops, spatulas etc.
v Particular attention will be required to ensure that the crevices, gaskets etc. are free from any contaminant.
v Dust control equipment must invariably be validated to confirm its capability to pick up errant material.
v Periodic chemical testing of the rinse from cleaned equipment will further increase confidence of cross contamination control.
9.0 WORK IN PROCESS
v These areas should be secured and accessible to the authorized personnel.
v Standard good manufacturing practices (GMP) and routine sanitary control and inspection will eliminate potential hazards.
v Prolonged hold needs to be discouraged/eliminated.
10.0 PACKAGING
v Strict observation of the SOP during the intimate packing will not permit any cross contamination.
11.0 PRECAUTION
v The above is only illustrative and is only through understanding and committed observance of prescribed procedures that we can produce without contamination.
