Your Compass for Pharma Success

PREPARATION, NUMBERING, REVIEW, APPROVAL, ISSUANCE AND CONTROL OF LAYOUTS

  • PROCEDURE:
  • Layouts shall be prepared for the following but not limited to
  • PROCEDURE:
  • Layouts shall be prepared for the following but not limited to
  • Facility Layout
  • Equipment Layout
  • Utilities layout (like HVAC, Water System, Compressed Air System)
  • Facility Layout includes the following but not limited to
  • Site layout
  • Different Area/section/ modules
  • Man Movement layout.
  • Material Movement layout
  • Drain Point Location layout.
  • Pest and Rodent control layout
  •     Equipment layout includes the following but not limited to
  • Location of equipment in area.
  • Schematic arrangement of the equipment
  • Utility layout includes the following but not limited to
  • Schematic arrangements of AHU, dust collector
  • Duct layout, grill layout.
  • Pressure Gradient layout, AHU Zoning layout, Area classification layout, P&ID of Water or Compressed Air Systems, AHU Schematic drawing.
  • Piping and Instrumentation diagram
  •   Preparation of layout
  • Engineering / Project department shall prepare the draft copy of layout A3 or A4 as per the format detailed in Annexure-II in consultation with user department layouts depicting only the outline of facility, rooms shall indicate the scale and the units.
  • Any short forms, diagrammatic representations, colour codes shall be explained in the layouts.
  • Engineering /project department shall put ‘DRAFT COPY’ stamp and shall circulate to the  technical/user departments and QA for review.
  • Upon receipt of draft copy, the reviewer shall review and send comments to the Engineering/Project department for incorporating the same in the final layout.
  • After incorporation of suggestion(s) as applicable, print of layout (QA copy, Display copies as applicable & Site Master File copy as applicable) shall be taken and shall be forwarded for signatures from Technical/User department and final approval from Plant QA In-charge or designee.
  • Engineering / Project department shall destroy the draft copy by shredding after the approval of the layout as per Annexure-II
  • In case of additional original copy, reprint shall be taken and shall be reviewed by Technical/User department and approved by Plant QA In-charge.
  • The layouts prepared by external consultants shall be verified and shall be numbered as detailed in section
  • Engineering / Project department shall do the verification and approval.
  • All approved layouts shall be maintained as per Annexure-I. (List of layouts).
  •       Issuance of layouts
  • Approved layout copies shall be submitted to QA for issuance of the same.
  • Documentation person shall enter the layout number and name in the logbook as detailed in Annexure-III.
  • User department shall raise document Requisition/Distribution slip, get it approved by Plant QA In-charge or designee.
  • QA shall issue the Photocopy of the layout as a DISPLAY copy and shall take the Signature of the receiver in the logbook.
  • In case, the layout is required to be issued to external agencies, regulatory bodies, customers, additional original copy, reprint shall be taken and shall be reviewed by Technical/User department and approved by Plant QA In-charge or Photocopy of QA copy or SMF copy shall be taken and issued with stamp Reference copy – Not for operational use.
  • Revision of Layouts
  • The existing layout, if revised, due to any changes/modification in the facility or system or equipment location, then Initiator department shall raise the change control with necessary justification.
  • After approval of the Change Control, Layout shall be revised, and the changes shall be recorded in the change history as per Annexure-IV.
  • All the existing controlled copies of layout shall be retrieved and forwarded to QA by concerned department(s).
  • Upon receipt of the retrieved copy, QA shall record and destroy the retrieved copy (ies) by shredding and maintain the record for the same.
  • QA copy of the layout shall be maintained by putting the stamp “OBSOLETE” in red on the layout and filed separately.
  • Plant QA shall control, issue, and retrieve the layouts and maintain records.
  •      Numbering of layouts
  •     A unique number shall be assigned for layouts.
  •    AAA/BBB/C/NNN-XX
  • AAA: Indicates Company name abbreviations.
  • BBB: Indicate Layout
  • C: Indicates for if facility layout the Facility Layout denotes as “F” , `E` for Equipment layout  `U` for Utility layout
  • NNN: Indicates serial no of layout start from 001,002, 003……
  • XX: Indicates version number of layout starting from 00 and continuing serially in increments of one unit.
  • For e.g. the facility layout no shall be given as AAA/LYT/F/001-00
  •    There shall be separate series for each type of layout i.e. Facility, Equipment and Utility.
  • REFERENCES:
  •   Not Applicable
  • ANNEXURES: 
  ANNEXURE No.TITLE OF ANNEXURE
Annexure-IList of Layouts
Annexure-IIFormat of Layout
Annexure-IIILayout Control Record
Annexure-IVChange History Sheet
  • ENCLOSURES: SOP Training Record.
  • DISTRIBUTION:
  • Controlled Copy No. 01                     Head Quality Assurance
  • Controlled Copy No. 02                 Head-Engineering
  • Master Copy                           Quality Assurance Department
  • ABBREVIATIONS:
  • P&I          :          Piping and Instrumentation
  • HVAC     :          Heating Ventilation and Air-conditioning
  • AHU        :          Air Handling Unit
  • QA            :           Quality Assurance
  • REVISION HISTORY:
  •  CHANGE HISTORY LOG
Revision No.Details of Changes Reason for ChangeEffective Date
00New SOPNot ApplicableTo be written manual

Annexure-I
LIST OF LAYOUTS

LIST OF LAYOUTS

Annexure-II
FORMAT OF LAYOUT

FORMAT OF LAYOUT

Annexure-III
LAYOUT CONTROL RECORD

Annexure-IV
CHANGE HISTORY SHEET

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