Before starting the activity, the PDN/QA executive carries out the required line clearance checks. If it meets the specified line clearance criteria, processing will start in accordance with the batch manufacturing record of each product.
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Oral Liquids
Oral Liquids
Oral liquids are homogeneous liquid preparations, usually consisting of a solution, an emulsion, or a suspension, of one or more active ingredients in a suitable liquid base. They are prepared for oral administration either as such or after dilution. They may contain other substances such as suitable dispersing, solubilizing, wetting, emulsifying, stabilizing, suspending, and thickening agents and antimicrobial substances for preservation. They may also contain suitable sweetening agents, flavoring agents, and permitted coloring agents. Classes of oral liquid dosage forms include:
- Oral Solution: an oral liquid that contains one or more active ingredients dissolved in a suitable base.
- Oral Drop: an oral liquid that is prepared to take in small quantity with the help of a suitable measuring device such as a dropper.
- Mixtures: an oral liquid containing one or more active ingredients suspended or dispersed in a suitable base.
Before blending the PDN/QA executive carries out the required line clearance checks. During blending the temperature/ humidity of the area is monitored and recorded as per BMR requirements. During blending In process samples are taken by QA and checked by QC as per required specifications. All details are recorded in the BMR.
Before compression the PDN/QA executives carries out the required line clearance checks. Only after line clearance compression shall be started. During compression In process samples are taken by QA and checked by QC as per required specifications. Details are recorded in BMR.
Before visual inspection the PDN/QA executives carries out the required line clearance checks. Only after line clearance coating shall be started as mentioned in the BMR. During coating In process samples are taken by QA and checked by QC as per required specifications. All details of the operation shall be recorded in BMR.
Before labeling and packing the PDN/QA executives carries out the required line clearance checks. Only after the line clearance does the labeling and packing activity starts. QA-cleared to be packed material transferred into the packing area lot wise and batch wise. Before labeling and packing, the over coding details on labels and cartons are counter checked by QA. After labeling and all packing materials issued and used are reconciled in the BMR. The final packed samples are collected and subjected to finished products analysis.
After labeling and packing activity is completed all the packed goods are appropriately labeled and checked by production. Quality assurance personnel after counter checking, stamps and sings on the Finished goods transfer note, after which the goods are transferred to the finished goods stores.