1.0 Purpose
1.1 To describe a procedure for handling of damaged / broken container.
2.0 Scope
2.1 Receiving, storage and sampling of incoming damage/broken containers of raw materials at NAME
Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Store
Officer is responsible to execute and implement the operation.
3.2 Head of Warehouse is responsible to monitor the system compliance.
4.0 Abbreviations and Definitions
4.1 SOP - Standard Operating Procedure
4.2 GRN – Goods Received Note
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1 Use Mask, Hand Gloves, and Eye Protector during transfer of raw materials. [If required]
7.0 Procedure
7.1 Receive the arrived materials according
to SOP for raw material receiving procedure.
7.2 Inspect each container for the following
(if any)
- Broken
security seal
- Breakage
of container
- Leakage
of container
- Container
without lid
- Unlabeled
container
7.4 The damaged containers of raw materials
shall be kept in a segregated place with a display ‘’ Damaged Containers
‘’
7.5 Check the inner bag of solid raw
material. If inner bag is found sealed / intact condition cover the drum/container with polythene. If
inner bag is found in torn condition, cover the torn place with possible. If not possible then
transfer the container in sampling booth and keep the content in new polythene bag placed in cleaned
drum/container.
7.6 Label ‘’ QUARANTINE‘’ on the damaged container.
7.7 Fill up the GRN and send it to QC.
7.8 Check Drum/Container of liquid raw
materials. If found leaks, then transfer the content in empty drum/container. If empty container is not available keep the
drum in upset/inclined condition
to stop leakage.
7.9 Inform the findings about damaged
containers to QA and QC department.
7.10 QC will collect sample form each damaged
container giving importance and will analysis thoroughly.
7.11 Sample all damaged containers individually
and affix ‘’UNDER TEST/SAMPLED’’
label to each container.
7.12 Transfer the damaged containers to ‘’ passed area ‘’ or ‘’ rejected area ‘’ as advice by Quality Control Department.
7.13 Follow the special instruction (if any)
about the use or retest of the material provided by Quality Control.
8.0 Reference Document
8.1 WHO GMP Guideline, trs-986, annex-2
8.2 In-house
9.0 Annexure
9.1 None
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
- |
|
|
|
|
|
11.0 Training
11.1
Training is required for store officer; trained by Head of Warehouse.
