Friday, April 25, 2014

Receipt, Issue and Control of HPLC and GC columns

  To lay down a procedure for receiving and allotting column number for HPLC
  and GC column.  
2.1 Documentation officer shall store, issue and control the HPLC / GC columns.
2.2 Head AD / QC to ensure compliance.  
3.1 After receiving GRIR from store, the officer Analytical Development / Quality 
  Control shall check the HPLC or GC columns against the purchase requisition.
3.2 The Officer Quality Control / Analytical Development shall submit the GRIR 
  with comments to Head - Analytical Development / Quality Control.
3.3 The Head - Analytical Development / Quality Control or their designee shall 
  approve the GRIR and send it to stores with comments.  
3.4 Officer - QC / AD shall raise the store indent for approved columns and submit
  the HPLC / GC columns to Documentation Officer.  
3.5 On the receipt of HPLC / GC columns the Documentation Officer shall enter the 
  details in the respective column stock card (Annexure-1) and column entry
  format in Microsoft Excel sheets (Annexure-3) and allot the column reference 
  number and keep the HPLC / GC columns in appropriate storage area.  The
  Documentation Officer shall mention the column reference number on 
  Manufacturers certificate, column and column box (if any) and file the manufacturer
  certificate in respective file.  
3.6 Column reference number shall consists of 6 characters.  
3.6.1 The first two characters denote LC for liquid chromatography or GC  for gas
3.6.2 The third character 'C' denotes column.  
3.6.3 The last three characters are serial numbers in sequential order, starting from 001
  for HPLC and GC columns separately.  
  Example :   
  The reference number for the first HPLC column received shall be numbered 
  as LCC001.  
  The reference number for the first GC column received shall be numbered 
  as GCC001.  
3.7 If any new HPLC / GC columns required, Officer Analytical Development /
  Quality Control shall raise "HPLC / GC columns request" and submit to Head -
  Analytical Development / Quality Control (Refer Annexure - 2).  
3.8 After approval, Documentation Officer will issue the new column to Officer -
  Analytical Development / Quality Control and enter the issue details in respective
  columns stock card (Annexure-1) and Microsoft Excel Sheet (Annexure-3).
3.9 While issuing the column, Officer-Documentation shall open "Column Usage Log"
  (annexure -5) by entering the column details, i.e., column description, In-house 
  column ID No., Part No., and Lot No.  
3.10 After receiving the column, Officer- AR&D/QC shall enter the details of Usage
  whenever the column is used for analysis.  
3.11 Once the column is expired Officer AR&D / QC shall raise the "HPLC / GC
  expired column handover form" (Annexure-4) and submit to Head AR&D / QC
  for approval along with the column and its filled usage log.  
3.12 After approval Documentation Officer shall enter receipt details in Microsoft
  Excel Sheet (Annexure-3).  
3.13 Officer Documentation shall file the HPLC / GC column request and HPLC/GC
  expired handover form in respective files.  
4.1 Specimen format of Columns Stock Card - Annexure 1.  
4.2 Specimen format of Columns request - Annexure 2.  
4.3 Specimen format of Columns control format - Annexure 3.  
4.4 Specimen format of Expired Columns handover form - Annexure 4.
4.5 Specimen format of Column Usage log - Annexure 5.  

Thursday, April 24, 2014

Cleaning Procedure for Dissolution Media preparation and Dispensing unit

  To lay down the procedure for the Cleaning of media preparation
  and Dispensing unit.  
2.1 Quality Control / Analytical R & D Officer, whoever performs the analysis.
2.2 Head - Quality Control / Analytical R & D Manager to ensure the Compliance.
3.1 Cleaning of Jacketted Pressure Vessel.  
3.1.1 Disconnect the electrical connections to the Jacketted pressure vessel.
3.1.2 Take the Jacketted pressure vessel to the washing area.
3.1.3 Open the lid of the vessel.  
3.1.4 Wash the lid and vessel with enough of potable water.  
3.1.5 Wash the vessel and lid with 2% Extran solution using soft nylon brush. Then wash
  with potable water followed by  purified water.  
3.1.8 After cleaning, place the jacketted vessel in its position.  
3.2 Cleaning of Vaccum filtration vessel  
3.2.1 Disconnect  the vaccum attachment, media transfer line and compressed air
  line from the vaccum filtration vessel.  
3.2.2 Take the vaccum filtration unit to the washing area.  
3.2.3 Repeat the steps 3.1.3 to 3.1.7  
3.3 Cleaning of media transfer tube.  
3.3.1 Pass about 5 litres of potable water followed by 1 litre of 2% Extran  solution
  through the media transfer tube using the Watson Marlow Pump.
3.3.2 Then pass the enough of  potable water followed by purified water through the 
  media line using the Watson Marlow pump.  
3.4 Cleaning of Media Filtration unit :  
3.4.1 Disconnect the media transfer lines form the filtration unit.
3.4.2 Take the filtration unit to the washing area.  
3.4.3 Open the lid and discard the previously used membrane filter and wash the
  unit with enough of potarble water followed by 2% Extran solution using soft
  nylon brush.  
3.4.4 Then wash with potable water followed by  purified water.
3.4.5 Place the filtration unit in its position.  
4.0 Documentation  : Nil