What is a warehouse?
A Warehouse is an important department in pharmaceutical industries where raw materials, packaging materials and finished goods are stored under suitable storage conditions.
Types of warehouses in pharma?
In pharmaceutical industries, there are 3 types of warehouses, which are,
- Raw materials store
- Packaging material store
- Finish Goods Store
What is RMS?
RMS is an abbreviation of raw material store & it is the type of warehouse in pharma where raw materials are stored and dispensed.
What is PMS?
PMS is an abbreviation of packaging material store & it is a type of warehouse in pharma where packaging materials are stored and dispensed.
What is FGS?
FGS is an abbreviation of finished goods store & it is the type of warehouse in pharma where finished goods are stored after packaging and are dispatched.
Material Flow In Raw Material Warehouse?
The material flow in the raw materials store is unidirectional to avoid a mix-up up meaning the material receiving and delivery is done through different pathways.
Steps Of Raw Materials Receiving?
- Document verification
- Unloading of materials
- Physical inspection
- Dedusting of materials
- Weight checking of materials
- Material shifting to quarantine
- Sampling of materials
- Testing of materials
- Release of materials
Checklist For Physical Inspection?
- The container must be intact, i.e not damaged.
- Weight checking of each container.
- Label verification of each container.
- Verification of Mfg & Expiry Date.
- Inspection of storage conditions.
- Data checking from the data logger.
What Is The Role Of a Warehouse In Pharma?
- Warehouses play an important role in pharmaceutical industries, starting from the receiving & storage of raw materials, packaging materials and finished goods till the dispatch of finished goods.
- The dispensing of raw materials and packaging materials is carried out in the warehouses of the pharma industry.
- The warehouse is also responsible for sampling of the materials and delivery of dispensed batches to the production department.
What Is GWP?
GWP stands for good warehouse practices. It includes all the good practices to fulfil regulatory requirements & it includes,
- Gowning procedure for entry & exit of the warehouse.
- Methods for receiving and storage of materials.
- Method for product dispatch.
- Procedure for handling rejected materials.
- Dispensing procedures.
- Sampling procedures.
- Use of PPEs.
- Training of staff.
- Safety protocols
What Is GSP?
GSP stands for good storage practices. All materials are stored at the temperature recommended by the manufacturer.
What Is Quarantine?
Quarantine is a place in
warehouse where materials are stored after receiving and are waiting for release by the quality control department.
What Is The Release Area?
When the raw materials are released by the quantity control department, these are shifted from the quarantine area to the release area, where materials are stored to dispense.
What Is The Rejection Cage?
Rejection cage is a red colour closed locked cage where the rejected or expired materials are stored.
Which Colour Scheme Is Used In Warehouses?
The materials placed in the quarantine area are labelled with yellow coloured labels, and the materials after release are labelled with green coloured labels in the release area. The rejected or expired materials are labelled with red coloured labels.
Checklist For Raw Material Receiving?
- Verification of company address.
- Verify that the received material is as per the purchase order.
- Verify that the received quantity is as per the ordered quantity.
- Ensure that the COA is provided along materials.
- Verification of approved vendor.
How to Clean Raw Material Containers?
All the raw materials containers are cleaned with lint lint-free cloth, a vacuum cleaner or a de-dusting tunnel.
How To Perform Sampling Of Raw Materials?
The sampling of raw and packaging materials is done in a sampling booth.
For excipients, we use the following formula
√n+1 & APIs are sampled 100%.
What is FIFO & FEFO?
- FIFO & FEFO are two most common terms used in warehouses of pharmaceutical sciences.
- FIFO is first in, first out. Old materials are dispensed first.
- FEFO means first expire, first out means we will dispense or dispatch the materials which are going to expire first.
What Is GRN?
GRN is a goods receipt note which is prepared by the warehouse officer after receiving the material.
Components Of GRN?
The GRN includes following information,
- GRN number
- Date of GRN
- Purchase Order No
- Date of purchase order
- Challan number & date
- Material Code
- Material Description
- Manufacturing Date
- Expiry Date
- Quantity Received
- AR number
- Number of containers
Area classification of the Warehouse?
CNC means clean but not classified.
Area classification of the dispensing area?
The materials are dispensed in the same area classification where they are manufactured. For exampl,e if tablets are manufactured in ISO class 8 at rest, then their materials will also be dispensed in ISO 8 & for sterile products, it will be in ISO 5.
What Is Weighing or Dispensing In Pharma?
The activity where materials are weighed as per the dispensing order from bulk containers is known as the weighing or dispensing process.
What Is Tare Weight, Net Weight, & Gross Weight?
The weight of an empty container or empty polythene is known as the tare weight.
The weight of material only is known as net weight means no packaging materials weight is included.
The weight of material+weight of the container or polythene is known as the gross weight.
Briefly Describe The Dispensing Process.
Take line clearance for dispensing & weight the exact quantities of specific materials in separate polythene bags as per the dispensing order. The process of weighing is carried out by trained operators & verified by QA and warehouse officers.
How To Handle Material Spillage In RMS?
Read SOP for Spillage handling in the following
What Is Access Control In a Warehouse?
The entry of personnel in the warehouse is controlled with a controlled entry system where entry cards are granted to specific persons for entry & exit from the warehouse to prevent chances of mix up or pilferage.
What Is Thermal Mapping?
The placement of temperature and humidity sensors at different locations of the warehouse to identify the hot and cold spots is known as thermal mapping.
What Is a Cool Temperature?
8 to 15 °C is the cool temperature.
What Is The Cold Temperature?
2 to 8°C is the cold temperature.
What Is a Post Dispensing Area?
The area used to store batches after dispensing.
How to Store Dispensed Batches In The Post-Dispensing Area?
In the post-dispensing area, batches are placed on pellets with proper identification.
Each batch is placed on separate pellets & the pellets must be off the floor & away from walls.
How are Dispensed Materials Delivered To Production?
Dispensed materials are delivered to the production department after batch verification, where the production pharmacist rechecks the complete batch in the post-dispensing area.
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