Line clearance procedure

Manostaxx

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SOURCE: https://qualityassuranceinpharma.blogspot.com.tr/2014/03/line-clearance-procedure.html

1.0.            OBJECTIVE:

To lay down the procedure for the line clearance of the area/ equipment.

• 0. SCOPE:

This SOP is applicable to all stages of manufacturing operations carried out before the start of operation / stage during the manufacturing/packing to avoid any contamination or mix ups of the previous product to the next product in the manufacturing area

• 0. RESPONSIBILITY:
  • 1. Production Officer shall be responsible to make the Machine / Line / Area ready to take line clearance before starting production / process.
  • 2. QA Officer / Executive shall be responsible to give line clearance.
  • 3. Production Head and QA Head shall be accountable for entire activities.
• 0. PROCEDURE:
  • 1. On request from concerned area for line clearance, the IPQA will Check all the points/line where the risk of contamination/ mix-up exist. For example:
    • 1.1. Check and ensure that the status label of previous product on poly bag/equipment is removed.
    • 1.2. Ensure that Room/equipment is cleaned as per respective SOP and ‘Room/equipment cleaned’ status label of area / equipment is affixed.
    • 1.3. Ensure that the equipment cleaning is recorded and completed on the relevant entries in the respective Equipment log book.
    • 1.4. Check and ensure all the materials (utensil, tools, container, documents etc.) are removed from rea, which were used in previous product.
    • 1.5. Ensure that the environmental condition of the area is maintained as given in the respective BMR/BPR and recorded in the relevant entries.
    • 1.6. Ensure that the balance(s) are verified and calibrated before the use and the record(s) are completed.
    • 1.7. Ensure that BMR/BPR is completed up to the current stage/time.
    • 1.8. Ensure that the released status of issued materials.
    • 1.9. Ensure that the software setting parameter entered in the HMI/MMI for the previous batch/product is deleted and clear for next batch setting.
    • 1.10. Ensure that Cleaning of the area/equipment (Type A and Type B) is not exceeding its validity period as per production SOP.
    • 1.11. The detailed check points during line clearance have been mentioned in the respective area check list from Annexure-I to Annexure-III.
    • 1.12. If the all requirements are fulfilled, then production and IPQA shall sign on the respective area checklist as well as sign in the defined place given in respective BMR/BPR if line clearance found satisfactory.
    • 1.13. In case of any failure to comply the line clearance, it shall be dealt with incident.
    • 1.14. After tacking corrective action, IPQA shall ensure line clearance again and then only batch record shall be signed.
  • 0. ANNEXURE:

Annexure-I      : Line Clearance Checklist for Manufacturing, Compression / Filling and Coating

Stage

Annexure-II    : Line Clearance Label

Annexure-III   : Line Clearance Checklist for Dispensing

• 0. REFERENCES:

Nil

• 0. ABBREVIATION     :

Abbreviation used       Full form of abbreviation used

QA                              Quality Assurance

BMR                           Batch Manufacturing Record

BPR                            Batch Process Record

IPQC                           In-process Quality Control

SOP                             Standard operating procedure

HMI                            Human machine interface

• 0. DISTRIBUTED TO:

Quality assurance

Manufacturing

Store

• 0. REVISION HISTORY:

Posted by Karamshi Chaudhari