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Area clearance during batch/product change over in Pilot Production facility. Quality Assurance

Area clearance during batch/product change over in Pilot Production facility. Quality Assurance

  • OBJECTIVE :
  • To provide procedure for  Area  clearance during batch/product change over in Pilot Production facility.
  • RESPONSIBILITY :
  • Officer Quality Assurance  for implementation
  • Quality Assurance Manager to ensure compliance.
  • PROCEDURE :
  • Note:
  • (i)  Type-A  Area clearance :
  • During batch change over of same product.
  • (ii) Type-B  Area clearance :
  • During batch change over of same product with different strength.
  • (iii)Type-C Area clearance :
  • During  product change over and  before bio-batch.
  • Area clearance – Type A/B :
  • Check that area is cleaned as per Type A / Type B cleaning procedure and ‘AREA CLEANED’ – Type A/B board is displayed.
  • Check that all equipments are cleaned and  ‘EQUIPMENT CLEANED-TYPE A/B ‘ tag  is displayed on each equipment.
  • Ensure that the  area cleaning checklist  Type A/B is filled and  signed  by Officer – Pilot  Production.
  • Check that no containers of previous batch are present in process area.
  • Check that no coded packing material of previous batch is present in process / packing area.
  • Inspect  floor, wall, ceiling, return  air  boxes / filters, grills  of   HEPA   filters, electrical   fixtures,  drains,  windows,  doors  etc. to  be   free   from   visible extraneous matter.
  • Fill inspection details in Area clearance  Checklist – Type A/B (annexure -2).
  • If found satisfactory clear the area for next batch of same product or same product with different strength.
  • If  found not satisfactory inform the  Officer – Pilot Production to repeat the cleaning process and reinspect.
  • Area clearance – Type C
  • Check that area is cleaned as per Type-C cleaning  procedure and ‘AREA CLEANED – TYPE  C’ board is displayed.
  • Check that all equipments are cleaned as per  Type-C cleaning procedure and “EQUIPMENT CLEANED – TYPE C’ tag  is displayed on each equipment.
  • Ensure that the “Area cleaning Check list – Type C” is filled and signed by ‘Officer -Pilot Production’ .
  • Check that all product storage containers are cleaned.
  • Check that no previous product containers are present in process area.
  • Check that no packing material of previous product is present in process and packing area.
  • Inspect  floor, wall, ceiling, return  air  boxes / filters, grills  of   HEPA   filters, electrical   fixtures,  drains,  windows,  doors  etc. to  be   free   from   visible extraneous matter.
  • Fill the inspection details in ‘Area clearance check list – Type C’ (annexure – 3)
  • If found satisfactory clear the area for next product or bio-batch.
  • If found not  satisfactory inform the  Officer-Production to repeat the cleaning process and  reinspect.
  • Forms and Records (Annexures)
  • Specimen format of “Area Clearance Checklist – Type A/B’ – Annexure 2.
  • Specimen format of “Area Clearance Checklist – Type C’ – Annexure 3.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number Reason for Revision
    00 New SOP

Annexure-1,2.

AREA CLEARANCE CHECK LIST – TYPE A/B

PILOT PRODUCTION FACILITY
Previous Product  :   Batch No.:  
S.No Location of inspection Inspection  inference of

Q.A Officer

Signature of

Q.A Officer

Remarks
1 Outer Corridor

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

2 Change Room

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

3 R.M.Storage Area

Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors.

windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

4 Process Area

Floor, wall, ceiling, R.A Filter/box,  Grills of HEPA filters, Pipelines, drains, dust extraction pendents, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

5 Tablet compression room

Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Dust extraction pendents, doors,

windows etc.,

Cleaning – Satisfactory /

Not satisfactory

6 Capsule filling room

Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors,  windows, etc.,.

Cleaning – Satisfactory /

Not satisfactory

7 Packaging room

Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

8 Film coating room

Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

9 Washing room

Floor, wall, ceiling, R.A Filter/box,  Grills of HEPA filters, Pipelines,  drains, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

GENERAL INSPECTION
10 No product containers of previous

batch observed in process area.

Yes / No
11 No coded packing material of  previous batch is present in  process / packing area. Yes / No
12 No visible extraneous matter or  powder is observed  in Pilot Production area. Yes / No
13 Equipments cleaned and Equipment cleaned-Type  A/B’ tag displayed. Yes / No
14 Area cleaning checklist-Type A/B

filled and signed by Officer Pilot Production.

Yes / No

Annexure-3

 AREA CLEARANCE CHECK LIST – TYPE C
PILOT PRODUCTION FACILITY
Previous Product  :  

Inspection  inference of

Q.A Officer

Batch No.:
S.No Location of inspection Signature of

Q.A Officer

1 Outer Corridor

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

2 Change Room

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

3 R.M.Storage Area

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, doors. windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

4 Process Area

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, Pipelines,  drains, dust extraction pendents, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

5 Tablet compression room

Floor, wall, ceiling, R.A Filter/box,  Grills of HEPA filters, out side  of Dust extraction pendents,

doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

6 Capsule filling room

Floor, wall, ceiling, R.A Filter/box,

Grills of HEPA filters, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

7 Packaging room

Floor, wall, ceiling, R.A Filter/box,  Grills of HEPA filter, Pipelines, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

8 Film coating room

Floor, wall, ceiling, R.A Filter/box,  Grills of HEPA filters, Pipelines,  drains, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

9 Washing room

Floor, wall, ceiling, R.A Filter/box,  Grills of HEPA filters, Pipelines,  drains, doors, windows, etc.,

Cleaning – Satisfactory /

Not satisfactory

GENERAL INSPECTION
10 No product containers of previous

product observed in process area.

Yes / No
11 Empty product storage containers  are found cleaned.  Yes / No
12 No packing material of previous product found.  Yes / No
13 No visible extraneous matter or  powder is observed  in Pilot

Production area.

Yes / No
14 Equipment cleaned and ‘Equipment cleaned-Type

C’ tag displayed.

Yes / No
15 Area cleaning checklist-Type C

filled and signed by Officer Pilot Production.

Yes / No

 

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