Thursday, May 30, 2013

KEY OF THE QUALITY PRODUCT IN PHARMACEUTICALS



We do think the key factors that smooth the quality production as well as their increasing market acceptance, are as following:






  PRODUCT DEVELOPMENT SECTION:

ü      According to product proposal they develop the formulation of a product, which ensure quality product within effective cost range.
ü   They are prepared a narrow in-house specification of raw materials/excipients that procured from the reliable vendor because quality raw materials ensure quality product.
ü      Analytical approach based on high performance sensitive equipments and efficient hands are ensured product quality until its shelf life.
ü   Prepared BMR and BPR so perfectly that the workers easily adapt it and meet fewer hazards during production.
ü      They also validate the process properly.
ü      Fortunately we have got chance to be involved in developmental process that enriched our theoretical knowledge as well as increase our interest. For this we are grateful to the administration.

   QA & QC DEPARTMENT:

 ü    The strong backup QA & QC with PD to the production section ensure claimed quality of product. QC perform the in process checking during production by using high tech instruments such as HPLC, FTNIR, FTIR, Atomic absorption spectrometer, Total organic carbon analyzer, Liquid particle counter, Gas chromatography etc.
 ü     QA have strong documentation process both manually and online (software) that facilitates to keep records of every step during production of a product.


 TABLET:

ü     Though it is a hazardous section, they know the art to produce a quality tablet without facing less problem as the man, material, machine- validated and almost dedicated to a product and latest tablet compression machine (Manesty Rotapress Diamond, Hanli-HLT-45, Cadmach, Sejong) and enrich BMR. From the following two examples it is clear-
ü      Wet granulation method of Ranitidine.
ü   The number of coating tablet (109) speaks about their efficiency in coating as it may hamper DT, Dissolution of tablet but the color of coating increase the acceptance.


 PARENTERAL:
It is theoretically possible but practically a tough job to maintain aseptic condition in parenteral section, liquid section. Though they have no separate building for penicillin & non-penicillin section but their sanitation system so well that they mostly overcome this limitation.
v     Recently a pet bottle section opened which meet up their in-house consumption and also speaks why they are called promising pharmaceutical.
v     Addition of automatic packaging machine increases productivity as well ass acceptance to the importer.
It seems to us that the following things may smooth their steps to the crest:
v     If pharmacists direct observation would possible to each step in every section.
v     If the software would more compatible with the level of employee

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