Cetirizine 5 mg Tablets

2. Weighing and Blending:

• All starting materials will be weighed accurately following a documented SOP (Standard Operating Procedure) by qualified personnel for Cetirizine Hydrochloride Tablets.
• Weighed quantities of Cetirizine Hydrochloride and Lactose will be transferred to a blender with sufficient capacity to ensure uniform mixing.
• Blending will be performed for a predetermined time per SOP to achieve a homogeneous mixture Cetirizine Hydrochloride and Lactose.

3. Granulation (Optional):

• Depending on the formulation of Cetirizine Hydrochloride Tablets, a granulation step might be necessary to improve the flowability and compressibility of the blend.
• Wet or dry granulation techniques can be employed following validated procedures.

4. Final Mixing:

• After blending or granulation, Microcrystalline Cellulose, Colloidal Silicon Dioxide, and Magnesium Stearate will be added to the primary blend.
• Intra-mixing will be carried out for a defined time per SOP to ensure uniform distribution of all components of Cetirizine Hydrochloride.

Tablet Compression:

• The final blend will be transferred to a validated tablet compression machine.
• Appropriate tooling (punch and die) will be selected to produce tablets with a target weight of 100mg, containing 5mg of Cetirizine Hydrochloride.
• The compression force will be adjusted to achieve tablets with sufficient hardness and friability per specifications.

6. In-Process Quality Control:

• Throughout the manufacturing process Cetirizine 5 mg Tablets , samples will be collected for weight uniformity, content uniformity, and other quality control tests per the pre-defined sampling plan.
• Any deviations from the specifications will trigger investigations and potential reprocessing as per SOPs.

7. Tablet Coating (Optional):

• An optional film coating can be applied to the Cetirizine 5mg Tablets for aesthetic purposes, taste masking, or moisture protection.
• A validated coating process will be followed, ensuring uniform coat application and compliance with specifications.

8. Packaging:

• Approved and pre-printed packaging materials will be used for the Cetirizine 5mg Tablets .
• Each pack will contain the product information leaflet, including Den Mark Pharmaceuticals Pvt. Ltd. as the manufacturer, batch number, expiry date, and storage conditions.
• Packaging will be performed in a designated clean area to minimize contamination risks of the Cetirizine 5mg Tablets .

9. Labelling:

• Labels will be applied to each packaging unit, following pre-approved artwork and containing all mandatory information as per regulatory requirements.

10. Quarantine and Release:

• Manufactured batches will be placed under quarantine until final product testing is completed.
• Quality control personnel will perform final product release testing per SOPs, including weight variation, disintegration, dissolution, and assay.
• Batches of Cetirizine 5mg Tablets will be released only after meeting all the pre-defined specifications.

10. Documentation and Records::

• All manufacturing steps, including raw material receipt, production processes, in-process controls, final product testing, and packaging, will be documented as per SOPs
• Batch records will be maintained for future reference and regulatory audits.