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Quality Control System & Activities -
 

Quality control laboratories housed in the same building but separated and independent from production department .quality control manager is reporting to the vp(operations).quality control is responsible for sampling ,inspecting and testing and subsequent release or rejection of  starting materials ,packing material,bulk intermediate,bulk finish products,finished products. Quality control laboratory is equipped with modern instrument like HPLC,Spetrophotomer,polarimeter,Karl Fischer Instruments etc.

Microbiology department is a part and parcel of quality control department and is responsible for microbiological attributes of water, products and environment control and analysis.

Quality control is further divided into two sections:-

  • In process quality control(IPQC)
  • Laboratory

In Process Quality Control :

In process quality control is responsible for ensuring that correct product is manufactured and correct label is attached. IPQC is also taking part in the activity of identifying and weighing correct ingredient in the stores ,filling and packing line operation.IPQC also check physical parameter while packing operations are going on.

  • Laboratory

Laboratories comprises of the following sections:-

  • Chemical Analysis
  • Instrumental analyses
  • Microbiological analyses.

These three sections undertake activity which are broadly described follows :

Analysis of incoming raw material, packing material, bulk and finish products, need based microbiological analysis, analysis potable water, purified water etc.

Calibration of the laboratory instruments and  thermometers ,validations of manufacturing process and  equipments.

Quality control issue need based batch manufacturing record and batch  packing record to production and packing line .

Laboratory takes care of packing components analysis for specification such as GSM, dimensions, print matter and other matter as per party’s in house specification method.

We do analysis of raw material and finished products for purity and assay with the general method of analysis, with help of sophisticated instruments like HPLC, Spectrophotometer, polarimeter, karal fischer apparatus ph meter etc as per  pharmacopoeia and/or party’s methods.

Microbiological department analyses raw material and finished products for microbiological limit test such as bacterial count and absence of specific pathogens.

Potable water and purified water is analysed for microbial limit test such as bacterial  count and  absence of specific pathogens. Environment control is monitored as per the  appropriate method.

Release of Batch

After the completion of all manufacturing and packing operations ,BMR and BPR are submitted to quality control department and is checked thoroughly to ensure that all manufacturing and packing operations are carried out as per the written guidelines and requirements of GMP under  supervision of competent technical staff. analysis reports are checked if BMR and BPR and analysis report  are found  to be in order and in the  predetermined specification limits, batch is released for distribution.

Analysis on contract basis:-

We send our sample for analysis using sophisticated instrumentation to chemo test laboratory and pharma solve speciliaties Pvt Ltd . the name of these laboratories are included in our license as approved laboratory for analysis . we provide them with necessary specification and test methods and get the analysis done accordingly.

Distrubution system:

The material which is released by the quality assurance is dispatched to the required destination from the factory . dispatch department maintains records of these dispatches.

Complaints and product recalls:-

Products related complaints are thoroughly investigated by QA department with the  help from production ,batch manufacturing records  and analytical reports are scrutinized. Reference samples are tested wherever necessary.

Complaint register is maintained to register all products complaints and the investigation findings.

Periodical self-inspections are carried out to ensure proper emplementations of cGMP’s

Conformance of various operations to written SOPs is verified during such inspections .

Self – inspection is carried out by a team of competant technical personnels from QC,production and engineering under the guidance from QA manager . the observations and corrective actions are recorded in the self-inspection report.

Preventive maintenance is executed daily/weekly/monthly basis.

 
 
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