SOP for Disposal in Production Department

In this post Standard Operating Procedure of SOP for Disposal in Production Department in pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for disposal in production area.

2.0 SCOPE:

This procedure is applicable to disposal in production department.

3.0 RESPONSIBILITY:

Technical Associate - for Execution

Officer/ Executive Production Department- for verification and implementation of SOP

Head Production Department- shall ensure compliance of the SOP

4.0 DEFINITION(S):

5.0 PROCEDURE:

5.1 All used polythene bags (used for granules, raw materials, compressed and coated tablets etc.) are collected in waste bin.

5.2 These polythene bags are collected by housekeeping person and are sent to scrap yard.

5.3 All the unused labels are to be torn into pieces before putting into the waste bin.

5.4 These torn labels are collected by housekeeping person and sent to scrap-yard.

5.5 Collect the rejected tablets or granules generated during each stage of the process in a polythene bag.

5.6 Take it to the washing area, put purified water so as to soak the tablet or granules, in presence of Production/QA Officer.

5.7 Send the soaked rejects for disposal.

5.8 Collect the rejected bottles generated during process in a plastic create, remove the liquid and ROPP caps from bottles.

5.9 Liquid solution material disposal by pouring solution along with sufficient qty of water.

5.10 Empty rejected bottles and ROPP caps collect separately in to polythene bag and sent to scrap yard.

5.11 The dust collected from the vacuum cleaner, de-duster, dust-collector and all the rejects generated during in-process checks also has to be disposed as per the above procedure.

5.12 Rejected punches, finger bags, sieves, screens and utensils are sent to scrap through the scrap note after getting the approval from Department Head. These shall be defaced before sending to scrap.

5.13 All the Used filtered Pad are to be torn into piece before putting into poly bag, shall put the scrap label and sent to scrap yard.

5.14 Damaged alloy steel letter defaced by breaking in to piece and sent to scrap-yard.

5.15 Used cartridge filter defaced by marking on body with marker and then cut with blade and sent to scrap yard.

5.16 Before sending the all rejected and used material to scrap area, shall affix “scrap label” duly filled and signed by both production and QA.

5.17 All scraped item which are directly contact with product, generated in Cephalosporin Block should be get decontaminated with 4.0 gram/liter NaOH solution as per SOP and then send for disposal.

6.0 ABBREVIATION(S):

QA : Quality Assurance

SOP : Standard Operating Procedure

ROPP : Roll on pilfer proof

7.0 REFERENCE(S):

SOP: Handling of Scrap

8.0 ANNEXURE(S):

Annexure I - Transfer record of Scrap

9.0 DISTRIBUTION:

9.1 Master copy : Quality Assurance

9.2 Controlled copy (s) : Production department, Quality Assurance, personnel and Administration department.

9.3 Reference copy (s) : Production (Tablet-granulation, compression, coating, packing), Production (capsule), Production(Liquid orals- manufacturing, filling ,washing and packing), Personnel and Administration department.

ANNEXURE I

TRANSFER RECORD OF SCRAP

Section: Month: