A pharmaceutical product’s quality is characterized as being pure, accurately identifiable, effective, and safe to use. Patients and customers have a moral (and legal) right to demand high-quality pharmaceuticals.
The warehouse is responsible for all incoming commodities (including labeling and packaging) as well as the release of finished products, making it an important part of the manufacturing process. As a result, GMP guidelines are in place to ensure that items are handled and kept correctly, with sufficient documentation.
GDP versus GWP
The term “GWP” refers to the methods used within the firm warehouse.
GDP primarily relates to the product’s transportation and distribution.
GMP includes both Good Distribution Practice (GDP) and Good Warehousing Practice (GWP). GDP primarily relates to the product’s transportation and distribution. The term “GWP” refers to the methods used within the MHRA approved warehousing UK.
The legal definitions and regulations for GDP and GWP are different. These standards reflect that after manufacturing and packaging, product quality might be dramatically changed.
In this module, “GMP” for the warehouse refers to GMP, GDP, and GWP procedures, standards, and regulations.
A final product is not subjected to any further inspections or quality control tests once it is brought into the warehouse. Nothing prevents the product from being delivered to the patient if it has degenerated or been destroyed at this point. To ensure that products arrive safely and in the same condition as when they left manufacturing, the warehouse must rely on procedures and well-trained workers.
Many products have been harmed as a result of poor warehouse storage conditions or rough handling during transportation. Temperature-sensitive active chemicals in biopharmaceutical products sometimes break down or deteriorate when exposed to heat or light, rendering them ineffective.
In order for a corporation to secure and deliver a quality product, a pharmaceutical warehouse must be properly managed and run in compliance.
Receiving goods, quality control, storing resources, components, and products, satisfying picking orders, and distributing the product to the marketplace are all examples of compliant practices. To maintain the integrity and stability of the product and its packaging, these measures must be entirely traceable.
Manufacturers can employ GMP warehouse rules to:
- Keep medicines safe during storage and transportation.
- Prevent product degradation from being exposed to extreme temperatures.
- Avoid contamination from other materials and mix-ups.
- Maintain product traceability and identity
- Prevent the use of expired or damaged materials or products.
What gets delivered to the warehouse?
The following items are not typically listed on any production bill of materials and have a streamlined check and release process. They frequently lack an in-house lot number, however this varies from company to firm.
- Toilet paper, stationery, and other non-production consumables (non-GMP material)
- Filters and lubricants are examples of processing materials.
- Buffers, chemicals, and other laboratory reagents
The latter two components listed above will almost always have their own quality control procedures.
Any production or packaging bill of materials will always include the following items. GMP quality control and release procedures apply to each of them. Each of these items will be assigned a unique lot number.
- Creating chemicals and starting materials
- Blister pack film, bottles, caps, vials, and seals are examples of packaging components.
- Labels, cartons, inserts/leaflets, and pre-printed tubes are examples of printed matter.
Receiving supplies into the warehouse procedure
The warehouse is in charge of the starting materials as they arrive at the facility. Various sorts of materials can be treated in a variety of ways. Materials used in production, for example, must be registered and examined for allowed supplier and grade (pharmaceutical or medical), although they may or may not require a unique identifier. Make sure you are familiar with your Standard Operating Procedures.
Starting chemicals used in product formation must constantly be examined to ensure that they meet the following criteria:
- Arrived from a reliable source
- Aren’t harmed
- For traceability purposes, are properly branded and identifiable with the supplier’s lot number.
- Are assigned a unique internal lot number.
- Inventory is recorded, and
- After quarantine, samples were taken for release testing.
- Because some of these chemicals can degrade when exposed to heat, they may need to be stored at specific temperatures or even frozen.
- A warehouse’s typical layout
Raw materials, packaging materials, intermediate or bulk product, and final product are some of the materials that are commonly stored in warehouses.
Some or all of the areas outlined below can be found in a typical warehouse.
Quarantine storage room for items that haven’t been inspected or tested yet. Quarantine materials cannot be utilized or released unless QC approves them.
To safeguard the safety of employees and the facility, several warehouses have a Dangerous Goods storage section. This is where flammable commodities like ethanol would be stored, for example. Here, special storage conditions are used, such as flame-proof cabinets.
For restricted commodities, such as poisons and addiction pharmaceuticals, some warehouses include a secured room. Only approved personnel have access to this area.
A distinct space for isolating faulty or recalled goods to prevent them from being issued or sold by accident.
Rejected batches are stored in a “reject” compartment.
The temperature in the cool room is normally kept between 2 and 8 degrees Celsius to prevent temperature-sensitive products (such as vitamins) from deteriorating.
It is critical to monitor the cool room temperature on a frequent basis to ensure that it is within normal operating parameters. A quarantine and a released area are frequently found in the cool room.
The first area where starting chemicals are opened is the sampling booth. To protect the material, the sampling chamber should have specific air controls to keep outside air out and to trap any dust formed during the sampling process. Cleaning sampling implements before and after each use is also required.
In this section, pay special attention to the air control systems, gowning, and chemical handling safety.
For batches that have been satisfactorily tested and passed for usage, there is a “released” area.
A quarantine zone is a place where things that haven’t been inspected or tested are kept. Quarantine materials cannot be utilized or released unless QC approves them.
Computer systems are used.
Computer systems are frequently used to monitor the status of materials and products during inspection and testing. Materials and goods may not need physical status labels or even be stored in different places if computers are used.
Warehouse inventory status control computer systems must be validated for dependability and error-free operation.
To ensure that information is entered correctly, tight procedures and security levels will be used. You should be aware of the security and protocols that go along with using these systems.
Some raw material supplier warehouses may opt to repackage bigger chemical containers into smaller order quantities. While this may appear to be a simple procedure, it must adhere to GMP guidelines and be documented. Only skilled personnel should undertake repacking according to a defined method.
What are some common repacking mistakes?
The smaller bags’ labels may not contain all of the same information as the original larger pack.
It’s possible that the repacking will take place in a room contaminated with other chemicals.
The smaller containers might not fit within the larger drum.
The re-packer might choose to use their own corporate name instead of the original manufacturer’s.
During the repacking process, the chemical may be hydroscopic (take up moisture).
If not handled properly, the chemical can be hazardous to one’s health, and the Material Safety Data Sheet (MSDS) may be missing.
Personnel and training in the warehouse
Warehouse staff must be proficient in a variety of duties, including the application of GMP regulations relevant to the warehouse, just as manufacturing personnel are trained in the application of GMP rules specific to their sectors. All warehouse employees, including contract and casual workers hired during peak times, must be taught.
SOPs specific to the warehouse’s functioning should also be taught to warehouse employees.
Here are some examples of specific talents needed by warehouse workers:
- Stock should be packed and labeled to keep it safe during transportation.
- Temperature and humidity gauges are examples of environmental monitoring displays.
- Be able to guarantee that materials and stockpiles are stored in the proper areas.
- Follow the safe handling instructions outlined on the Material Safety Data Sheet for each chemical (MSDS).
- Maintain inventory records and conduct stocktakes.
- On a first-in, first-out basis, accurately find and choose the appropriate goods from pick lists and orders.
- Recognize circumstances in which items or chemicals are at risk, such as spillage, broken packaging, or missing labels.
- Use picking equipment, such as a forklift or a bay picker, safely.
- Maintain correct paper records and accurately enter stock into the computer system inventory.
Contamination and degradation prevention
Some fundamental warehouse standards must be followed to avoid possible contamination or deterioration of products during warehousing:
- There should be no unsealed packs. This eliminates the risk of environmental contamination or pest infestation.
- All chemicals and goods must be kept at their designated temperature zones, such as those labeled:
- Store between 2 and 8 degrees Celsius.
- Avoid freezing.
- Keep it below 25°C.
Make use of a FIFO (first-in, first-out) system. Chemicals and pharmaceuticals decay over time and have expiration dates. If stock is not rotated, partially degraded or aged materials may be issued.
Follow the chemical spill response measures to protect employees and other products. All incidents should be reported to management.
When not in use, close the outer doors and exits. Dirt and vermin from the outside may taint the cattle.
Never utilize any material or product that isn’t labeled or isn’t labeled correctly. If a label is missing, the stock should normally not be used.
Preventing warehouse confusion
In a busy warehouse, starting materials are delivered daily, production is picked up daily, in-process bulk goods are stored regularly, finished products are received, and finished stock is released to distributors. Many warehouses become congested due to a lack of space.
Staff must keep records and sometimes affix labels to indicate status during all of this stock movement.
As there are several potential for mix-ups on a regular basis, there are also GWP guidelines in place to help prevent them:
- Inbound and finished items are quarantined until they are approved for release.
- Sort materials according to their current status (e.g., there should be only released labeled stock in the released store).
- Make sure that UINs and batch numbers are easily accessible and legible.
- If at all possible, keep only one sort of material in a single spot. (Please note that various companies may have differing perspectives on this.)
Separation of materials and products
Practice good physical segregation and/or validated electronic segregation to ensure that only the correct materials or goods are distributed. Physical and electronic segregation are crucial in the case of defective and recalled items.
If a validated computer system is not used to regulate location, it is a GMP/GWP mandate that commodities with different statuses be physically located in different and defined areas. (Even when using verified computer systems, some organizations use physical segregation.)
Physical segregation reduces the chances of someone picking and utilizing the incorrect material by accident.
Before selecting an item, always double-check its status and location. Report the error to your supervisor if the selected lot is quarantined or rejected.
Separation of Electronics
An MRP computer system is used by many warehouses to keep track of their inventory. Only authorized individuals should have access to the computer system, which must be validated (100 percent dependable).
Warehouse computer systems are typically used to:
- Register inbound items, including quantities, lot numbers, expiration dates, and suppliers, as well as their status (e.g. Quarantine)
- Change a lot or batch’s status.
- Allow or disallow planners and dispatchers to pick products electronically depending on the status of the lot or batch.
- Track inventory movement to specific warehouse locations so that only the appropriate material or product is chosen for usage or release.
- Allow for stock takes and traceability by providing an accurate history of stock movement.
In conclusion, the warehouse computer system performs a key duty, and employees who must utilize it must be adequately trained. Furthermore, employees should never discuss their credentials or log on or off other employees.