This article about the preventive actions initiated to avoid cross contamination in pharmaceuticals
1.1 Premises & Building design
The premises should restrict the entry of pests and insects into manufacturing area and this purpose can be served by good design
Unauthorized persons should not enter the any unit of manufacturing area or QC or QA or packing area
Surfaces of walls, floors, ceilings should be free from cracks and smooth and shouldn’t shed any paint particulate matter
The walls should permit easy cleaning
Light points and ventilation should be designed to ease cleaning and prevent recesses in creation
1.2 Equipment
The surface of equipment should be free from pitting
The contact surfaces of equipment’s should be inert and shouldn’t be absorptive or additive
Shedding clothes, brushes and bristles should not be used as they may cause contamination
Manufacturer should ensure that materials of the product previously manufactured are cleaned and removed completely
Maintenance operations and repair should not alter the quality of the product
1.3 Personnel
Personnel should undergo appropriate health checkup before and during their employment
To prevent cross contamination the personnel should be taught of gowning practices and maintaining of personal hygiene.
The personnel should wash their hands regularly.
Penicillin like sensitive products should be handled carefully as they may cross contaminate and cause fatal effects. Hence there production should be carried in dedicated facilities
Personnel should avoid direct contact with products at any stage
Personnel protective equipment should be provided by the company
1.4 General considerations
Procedures should be clear and should be followed to achieve the objective of quality for the product.
All the procedures regarding materials and products regarding their receipts, sampling, storage, cleaning, labelling, quarantine and dispensing should be in accordance with written procedures
Precautions should be taken so no deviations from procedures and instructions occur and if deviations occur then they should be treated as said in procedures
To avoid discrepancies from acceptable limits yields and quantities should be checked
Operations on different products should not be conducted in the same premises to prevent cross contamination or mix up
At each step in processing every material and equipment should be labelled with their indication, batch number and strength. If applicable then the stage of production should also be mentioned and few cases also mandate the name of the previous product that is processed.
The production premises should be accessed by only personalized personnel
Non medicinal products should not be produced in places where the equipment and pharmaceutical products are produced.
Care should be taken so that the in process controls don’t impact the product quality or any other product as in case of mix up or cross contamination
1.5 Related documents
Cross contamination, premises & building design, equipment, personnel
