A pharmaceutical product’s quality is defined as being pure, accurately identified, safe and effective. Patients and customers have the legal (and ethical) right to expect high-quality pharmaceutical products.
Warehouses play a key role in the manufacturing of quality products. They are responsible for receiving all goods, including packaging and labeling, and for releasing products. GMP rules are in place to ensure materials are stored and handled properly.
GDP vs GWP
GWP refers specifically to practices within the company warehouse.
GDP is the transportation and distribution of the product.
- GMP includes Good Distribution Practice (GDP), and Good Warehousing Practices (GWP). GDP refers to the transportation and distribution of the product. GWP refers specifically to the practices within the company warehouse.
- Each GDP and GWP have its legal definitions and regulations. These regulations recognize the potential for product quality to be greatly affected if manufacturing and packaging have occurred.
- This module explains that “GMP” refers to the warehouse’s procedures, rules, and regulations. It includes GMP, GDP, and GWP.
After a product has been delivered to the healthcare logistics companies, it is not subject to any quality control or inspections. There is no way to stop the product from being delivered to the patient if it is damaged or degraded at this stage. To ensure products arrive safe and in the same condition they were when they left manufacturing, warehouse staff must follow procedures and be well-trained.
Poor warehouse storage conditions and poor handling during transport have led to many product damage cases. Biopharmaceutical products often have temperature-sensitive active ingredients that break down or degrade if exposed to heat or light, thus becoming ineffective.
To ensure the quality of a product, a pharmaceutical warehouse must be managed well and maintained in compliance.
These practices are designed to ensure that goods are received safely, quality is maintained, products are stored properly, picking orders are fulfilled, and the product is shipped to the market. To protect the integrity and stability of the product’s packaging and packaging, these practices must be easily traceable.
GMP rules allow manufacturers to:
- Protect medicines during transport and storage from possible damage
- Avoid exposing the product to extreme temperatures.
- Avoid contamination by other materials and mix-ups
- Protect product identity and traceability
- Do not use time-expired, damaged, or ruined material.
What goes into the warehouse?
These goods are not included on any production bills of materials and have a simplified release and check. They are not often assigned an in-house lot number, although this can vary from one company to the next.
- Non-production consumables (non-GMP material), e.g. toilet paper, stationery
- Processing materials, e.g. Filters, lubricants
- Laboratory reagents (e.g. buffers, chemicals
These items will often have their own QC approval process.
These goods will always be on any production or packaging bill. Each one is subject to GMP quality control procedures and release procedures. Each lot number will be unique for all these goods.
- Chemicals and starting materials for manufacturing
- Packaging components, e.g. Packaging components, e.g., blister pack film, bottles and caps, vials, seals
- Print matter, e.g. Labels, cartons, inserts/leaflets, and pre-printed tubes
Method for receiving materials into the warehouse
The warehouse is responsible for receiving starting materials when they arrive at the facility. There are many ways to treat different types of materials. Materials used in production must be registered and checked to ensure that they are approved as a supplier or grade (pharmaceutical, medical). However, each material may not require a unique identification number. Make sure you are familiar with your Standard Operating Procedures.
Start chemicals that are used in product formulation will need to be inspected to ensure they work properly.
- Originated from an approved supplier
- Do not damage
- Correctly labeled and identified with supplier’s lot number.
- Are given a unique in-house lot number
- Added to inventory
- Then, the samples are taken for release testing.
Some chemicals can also be damaged by heat so they should be kept at controlled temperatures or frozen.
A typical layout for a warehouse
Warehouses are usually classified according to the type of material they hold, such as raw materials, packaging materials, and intermediate or bulk products.
One typical warehouse may contain all or some of the following areas.
- You can store goods in Quarantine until they are inspected and tested. Materials kept in Quarantine can’t be used or released without approval by QC.
- To ensure safety, some warehouses have Dangerous Goods Storage Areas. This area could be used to store flammable goods like ethanol. Here, special storage conditions like flame-proof cabinets are used.
- Some warehouses contain a locked area that can be used to store restricted goods such as drugs of addiction and poisons. This area is only accessible to authorized personnel.
- There is a separate area to identify defective or recalled goods and ensure that they are not sold or issued by mistake.
- Reject area for batches that have been rejected.
- The cool room is usually operated at 2degC – 8degC so temperature-sensitive materials (e.g. Vitamins do not deteriorate
Regularly check that the temperature in your cool room is within acceptable operating temperatures. The cool room typically has a quarantine area and a release area.
- The first place that chemicals are opened is the sampling booth. The sampling room must have air controls that prevent outside air from entering and contain dust from sampling to protect the material. Also, sampling instruments must be cleaned before each use.
Pay special attention to air control systems, gowning, and safe handling chemicals in this area.
- This is an area that has been released for batches that have been tested and approved for use.
- Quarantine is a place to store goods that haven’t been tested or inspected yet. Materials kept in Quarantine are not allowed to be released or used until they have been approved by QC.