Procedure for Line Clearance Before Commencing any Manufacturing Operation : Pharmaceutical Guidelines

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Procedure for Line Clearance Before Commencing any Manufacturing Operation

Know the procedure for the line clearance checklist in different manufacturing departments before starting the manufacturing operation as per GMP.

1.0 Line clearance prior to dispensing

1.1 Check the dispensing area for the following:
1.2 All materials from previous operations have been removed.
1.3 Equipment and accessories from previous operations have been removed.
1.4 Paperwork from previous operations has been removed.

1.5 Status labels from previous operations have been removed.
1.6 The reverse laminar flow booths and surrounding are clean and status is displayed.
1.7 All the equipment and accessories required for dispensing are clean and labeled as such.



2.0 Line clearance prior to sifting / granulation / blending / compression / capsule Filling/ tablet inspection/ tablet coating / capsule Inspection and polishing

2.1 Check the areas for the following:
2.2 All materials and residues from previous operations have been removed.
2.3 Utensils and accessories from previous operations have been removed.
2.4 Containers used for previous operations have been removed.
2.5 Paperwork from previous operations has been removed.
2.6 Status labels from previous operations have been removed.
2.7 All equipment is clean and labeled as such.
2.8 Areas are clean and status is displayed.

3.0 Line clearance prior to overprinting

3.1 Check the area for the following:
3.2 All materials from previous operations have been removed.
3.3 All stereos from previous operations have been removed.
3.4 Paperwork from previous operations has been removed.
Related: SOP for Line Clearance in Manufacturing Area

4.0 Line clearance prior to primary and secondary packaging

4.1 Check the area for the following:
4.2 All materials and residues from previous operations have been removed.
4.3 Containers used for previous operations have been removed
4.4 Paperwork from previous operations has been removed.
4.5 Status labels from previous operations have been removed.
4.6 All stereos from previous operations have been removed.
4.7 All equipment is clean and labeled as such.
4.8 Areas are clean and status is displayed.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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2 comments: Post Yours! Read Comment Policy ▼

  1. do you have a form for line clearance?

    ReplyDelete
  2. and also check the temp,rh and magnhelic gauge reading.

    ReplyDelete


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