Warehouse receives the Raw materials against the purchase order. They check all the parameter such as the specification mention on the label and purchase order and the condition of the consignment. If the parameters does not match the consignment is reject.
Our QA team takes samples at various stages of process and asks QC to check the define or specific parameter. QC checks the parameters in labs where as QA check on site. QA has final authority to release and reject the product depending of the QC results.
QA will withdraw 100% containers samples from the API consignment, and under root N+1 from the excipients. All samples are test in our in-house laboratories where QC submits the test report to QA. QA approved the materials, if the results match with the specification. QA gives specific AR number for the consignment for traceability of the material.
Here all materials are charged in the SS316 L vessel which is fully equipped with hot water, vacuum and chilled water facility. The process is according to batch manufacturing record till the uniform viscous mass is prepared, all process steps are record in batch manufacturing record. QA samples the required quantity and send to QC for testing. After approval the gelatin mass is used for the particular batch.
Soft capsules manufacturing process is called encapsulation .Gelatin capsule shell manufacturing, medicament filling and sealing of the capsules under 1,00,000 class area with FFS (form fill seal technology)systems. Various types of the shape, size and color capsule depend on the die roll sizes can be manufactured.
Encapsulation stage capsules contains high moisture content in which capsules are not stable in any way so to main its shape, size and appearance stable product drying is a critical step. The capsules are dried in two steps, first step is semidrying or tumbler drying in which capsules are rotate at slow speed in the SS316 baskets for specific period and then completely dried in low RH area where humidity is below20RH. Here capsules are kept in the fiber trays for specific time.
Printing is the marketing requirement where each capsule is printed with a brand name or a logo with edible ink. This ensures the product identity. This is fully atomized process carry out in classified area.
The product are packed into virgin poly bags and keep in the PVC bins waiting for the QC/QA release. QC require time to test various parameters. Till the procedure is complete the product must be secure for the integrity and identity.
This is the last stage of the finish product. The product is packed in the unit packs such as in Alu-Alu pack, Aluminum and PVC blister ,bottles etc The unit pack contain all compulsory regulatory information on the pack label or strip.
The strip is again packed in secondary packing material like mono carton ,carton, GB boxes, shipper box etc.
This is the last stage when the product is ready in final pack form for actual marketing. QA sample the required quantity and sends samples to QC for testing. QA verifies all the documents pertaining to the whole process. QA also retains some samples for compliances of the regulatory body, and these samples kept at specific storage condition for 1 year after the expiry. After Approval the product are transfer to FGS from there it is distributed to customers.
All active and excipient materials are processed according to batch manufacturing record in presence of competent technical staff. QA samples the required quantity and send to QC for testing .After Approval the medicament used for the particular batch.
In case any raw material or packing materials does not comply according to QA check, calibration or calculation and if they find that the material dose not comply with the specifications then the material is sent back to party but in the in the case of printing packing material is destroyed in presence and consent of the manufacturer.
We have specification of each individual packing material. Our QA staff will sample each and every consignment, and the each sample is tested by our QC staff. Then the QC team will make a report for the same. QA verify specification Vs report and then approved the material. All containers are then put APPROVED label in green color.
At various stages such as Raw materials receive ,Medicament Preparation, Gelatin mass, various in process stages & finish product samples are taken by our QA team and sent to QC team for tests .All samples are tested by QC team and reports are submitted to QA team. QA verify the result Vs specification and release or reject the sample.