Line clearance procedure

1.0.            OBJECTIVE:  

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

2.0.            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

3.0.            RESPONSIBILITY:

3.1.            Production Officer shall be responsible to make the Machine / Line / Area ready to take line clearance before starting production / process.

3.2.            QA Officer / Executive shall be responsible to give line clearance.

3.3.            Production Head and QA Head shall be accountable for entire activities.

4.0.            PROCEDURE:

4.1.          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:

4.1.1.       Check and ensure that the status label of previous product on poly bag/equipment is removed.

4.1.2.      Ensure that Room/equipment is cleaned as per respective SOP and ‘Room/equipment cleaned’ status label of area / equipment is affixed.

4.1.3.      Ensure that the equipment cleaning is recorded and completed on the relevant entries in the respective Equipment log book.

4.1.4.      Check and ensure all the materials (utensil, tools, container, documents etc.) are removed from rea, which were used in previous product.

4.1.5.      Ensure that the environmental condition of the area is maintained as given in the respective BMR/BPR and recorded in the relevant entries.

4.1.6.      Ensure that the balance(s) are verified and calibrated before the use and the record(s) are completed.

4.1.7.      Ensure that BMR/BPR is completed up to the current stage/time.

4.1.8.      Ensure that the released status of issued materials.

4.1.9.      Ensure that the software setting parameter entered in the HMI/MMI for the previous batch/product is deleted and clear for next batch setting.

4.1.10.  Ensure that Cleaning of the area/equipment (Type A and Type B) is not exceeding its validity period as per production SOP.

4.1.11.  The detailed check points during line clearance have been mentioned in the respective area check list from Annexure-I to Annexure-III.

4.1.12.  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.

4.1.13.  In case of any failure to comply the line clearance, it shall be dealt with incident.

4.1.14.  After tacking corrective action, IPQA shall ensure line clearance again and then only batch record shall be signed.

5.0.            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

6.0.            REFERENCES:

Nil

7.0.            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

8.0.            DISTRIBUTED TO:

Quality assurance

Manufacturing

Store

9.0.            REVISION HISTORY:

Revision	Change Control Number	Reason for the Modifications