Product Process

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The facility has provision to manufacture small volume Parenteral products in polyethylene Ampoules.The entire operations are carried out under the supervision of expert technical staff.All the processing activities are recorded in the Batch Manufacturing Records (BMR) on the process proceeds. Inprocess checks are carried out at predefined critical stages and Q.A. department gives final analysis done and release after complete evaluation of the batch document.Following flow diagrams show the important processes and related activities in production.

Each consignment of material received is examined visually and damaged goods are kept separate and await Quality Control’s further instructions for disposal or return. On verification of quantity received and making batch wise segregation identification number is given serially & all the containers are labeled as `UNDER TEST’ with details such as name, quantity, No. of containers, manufacturer’s name, material code No. etc. and material is then quarantined.Samples are drawn as per sampling plan and tested in detail as per specifications by quality control. On completion of tests Q.C. decides whether the material is approved or rejected and accordingly if material is approved, ‘APPROVED’ labels are affixed and material is transferred to “Approved Material” storage area.
All packaging materials are handled as per above procedure only and Approved/Rejected status labels are affixed accordingly. Printed packaging materials are stored securely under lock & key and issued in requisite number only. At various places of operations separate areas are created so that the material or product is held on ‘UNDER TEST’, ‘APPROVED’, ‘REJECTED’ & ‘QUARANTINED’, etc. All raw materials are transported in closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance instructions are followed for material status.

For all rejected materials, the materials are separated from other ‘APPROVED’ or ‘UNDER TEST’ lots and ‘REJECTED’ labels are affixed by the Quality Control persons. The rejected material is transferred to a separate `Rejected Materials’ area. Quality Assurance decided the fate of such rejected materials as to destroy, reprocess or to refer to the supplier.

Process validation is a documented program, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
We follow the following system with regard to process Validation:
i) Establish specifications and performance criteria.
ii) Select methodology, process & equipment to ensure the product meets the specification.
iii) Test the final product using validated analytical methods in order to meet specification.
Following steps supports the above steps:
i) Calibration, verification and maintenance of process equipments.
ii) Qualification of both process & equipment.
iii) Challenge, audit, monitor or sample the recognized critical or key steps in the process.

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