SOP for Line Clearance : Pharmaceutical Guidelines

SOP for Line Clearance

Standard operating procedure for the line clearance in the sterile production area.

1.0 OBJECTIVE

To lay down a procedure for line clearance for manufacturing, filling, and packing line.

2.0 SCOPE

This procedure applies to the line clearance in the production department of the manufacturing facility.

3.0 RESPONSIBILITY

3.1 Executive – Quality assurance - Prepare the SOP and follow the SOP accordingly
3.2 Manager – Quality assurance - Provide the support to the implementation of SOP and maintained the records.

4.0 ACCOUNTABILITY

4.1 Technical-Director

5.0 PROCEDURE

5.1 For packaging operations

5.1.1 This is applicable to all packaging operations including blister and overprinting of labels, carton etc.
5.1.2 Production officer is responsible for carrying out the line clearance.
5.1.3 IPQA officer is responsible for approval of line clearance after checking the area/machine as per the checklist is given in the batch manufacturing record (an additional checklist may be used by IPQA, which if used shall be attached to batch manufacturing records).
5.1.4 Before bringing the packing material and the material to be packed into the packing hall, all packing items like cartons, labels, leaflets and blisters of the previous batch/product shall be removed from the packing line.
5.1.5 All such removed items shall be stored in their respective storage staging areas.
5.1.6 Checking shall be done underneath of packing belt, conveyors, labeling machines, workbenches for any leftover of the previous batch or material and ensure there is no left over.
5.1.7 Check the area as well as the respective machines for cleaning.
5.1.8 Before starting the packing activities of a fresh batch of the packing area to be approved as free of packing components of the previous product.
5.1.9 All new overprinting or batch coding of blisters, labels, cartons for the new batch shall be checked by the production officer and counter check by IPQA officer for correctness and quality.

5.2 For manufacturing and filling operations

5.2.1 Production officer to carry out the line clearance and he is responsible for removing all the traces of the previous product from the area/machine.
5.2.2 IPQA office to check the area/machine for the traces of any previous product as per the checklist given in the batch manufacturing records and certify the line clearance for subsequent operations.
5.3 IPQA persons should use a green pen only.
5.4 Daily activity should be mentioned in the log book.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 IPQA: In-process Quality Control





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


Click Here

No comments: Read Comment Policy ▼

Post a Comment


Follow Pharmaguideline



ADVERTISE HERE


GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts