Production Facility

We have separate production halls in order to produce 3 separate products simultaneously

Production Area = 301 sq. meter

Production

1. Production Operation:-
  All processing activities are documented & have clearly described processing documents.
2. Material Management:-
  Upon receipt of raw / packing materials, the material is unloaded against checking with the delivery note. The details are recorded in the Inward register. Supplier’s batch number, quantity is cross-verified & after that GRN is prepared. The store department then intimates to QC for sampling. QC personnel do the sampling as per the sampling procedure. Sample containers are labeled with the “UNDER TEST” label in Yellow. Samples are analyzed as per the required approved specifications and on passing “APPROVED” label in green is affixed and if does not meet the specification then a red “REJECTED” label is affixed.
  On approval, materials are transferred to the approved area and rejected materials moved to the secure rejected area. Materials are accepted from an approved supplier. The controlled list of approved suppliers is available in the store’s department. Dispensing of material is a controlled operation carried out by stores & production department. Materials are issued by the store’s department on receipt of requisition from the production department.
  Line Clearance procedures are followed for manufacturing operations. The identity of material at the processing stage is identified by the status label. The dispensed raw material is processed as per instructions defined in MFR. MFR includes the steps to be followed for proceeding to manufacture the material.
  In-process controls are carried out as per the frequency & procedure defined in BMR / BPR / BMPR. These operations are controlled by a production officer. In-process samples are checked by QC prior to blending and/or packing operation.
  Finished products are tested and approved by QC. After approval from QC & authorization from QA, the finished product is transferred to the finished goods area.
  Control of non-conforming products: As per SOP if the material is not conforming to the required specifications, then OOS is performed and if still does not passes then it is rejected and kept under a secured rejected area. The rejected raw material is sent back to the supplier & rejected packing material is also sent back to the supplier. If the finished product is not conforming to the specification then QA investigates the problem and it is discussed with the technical team for action. Reprocessing & reworking will be considered if there is a need & technically justified. Details of OOS and/or any CAPA is recorded.
3. Validation (Process):-
  Validation is an approach to assure that the activity performed is consistent with predetermined criteria. There is an SOP that deals with validation SOP. Retrospective validation data is available with the company.
  
  Process Validation: It has the following types-
  Prospective validation
  – Conducted for the first three commercial batches.
  – Conducted prior to distribution either of new product or product made under the revised manufacturing process.
  
  Concurrent validation
  – Conducted once a year after completion of prospective validation.
  – Conducted on an existing product that is not previously validated or insufficiently validated.
  
  Retrospective validation
  – Conducted for existing products only by collecting historical data.
  
  Revalidation is needed to conduct any change in the manufacturing process, manufacturing machines, etc.