A pharmaceutical product’s quality is characterized as its purity, proper identification, effectiveness, and safety. Patients and customers have an ethical (and legal) right to demand high-quality pharmaceuticals.
The warehouse is responsible for all incoming commodities (including labeling and packing) as well as the release of finished products, making it vital to the production of high-quality goods. As a result, GMP guidelines have been established to guarantee that materials are handled and stored correctly, as well as that adequate documentation is kept.
Gross Domestic Product (GDP) against Global Warming Potential (GWP)
The term “warehouse practices” refers to the procedures used within the company’s warehouse.
The term “gross domestic product” (GDP) relates to how a product is transported and distributed.
- GMP has two distinct parts: Good Distribution Practice (GDP) and Good Warehousing Practice (GWP). The term “gross domestic product” (GDP) relates to how a product is transported and distributed. The term “warehouse practices” refers to the procedures used within the company’s warehouse.
- Both GDP and GWP have their own set of legal definitions and rules. These rules acknowledge that after production and packing, product quality might suffer dramatically.
- “GMP” for the warehouse in this module encompasses GMP, GDP, and GWP procedures, standards, and regulations.
Once the final product arrives at the pharmaceutical warehousing, it is no longer subject to any inspections or quality control tests. There is nothing to prevent the product from being delivered to the patient if it is damaged or defective at this stage. To guarantee that the goods arrive safely and in the same condition as when they left the factory, the warehouse must rely on protocols and well-trained staff.
Many products have suffered as a result of inadequate storage conditions or harsh handling during transport. Biopharmaceutical products often contain active ingredients that are temperature sensitive and deteriorate or spoil when exposed to heat or light, rendering them unusable.
In order for the Corporation to ensure and deliver a quality product, the pharmaceutical warehouse must be properly managed and maintained in accordance with requirements.
Receiving goods, quality control, storage of inputs, ingredients and products, fulfilment of picking orders and distribution of the product to the market are all part of these activities. These methods must be fully traceable to ensure the integrity and stability of the product and its packaging.
Manufacturers can comply with GMP warehousing standards by:
- Keep medications safe when they’re being stored and transported.
- Keep the product from degrading due to extreme temperatures.
- Prevent contamination from other materials and mix-ups.
- Maintain the traceability and identification of your products.
- Prevent the use of materials or products that have passed their expiration date or are damaged.
What kind of goods are received at the warehouse?
The following items are not often seen on a manufacturing bill of materials and have a streamlined inspection and release procedure. They frequently lack an in-house lot number, however this varies by organization.
- Toilet paper, stationery, and other non-GMP consumables
- Filters, lubricants, and other production materials used in processing
- Chemicals, buffers, and other laboratory reagents
The latter two things on this list will almost always have their own quality control procedures.
Any production or packaging bill of materials will always include the items listed below. GMP quality control and release procedures apply to all of them. Unique lot numbers will be assigned to each of these products.
- Making chemicals and raw materials
- Blister packs, bottles, caps, vials, and seals are examples of packaging components.
- Labels, cartons, inserts/leaflets, and pre-printed tubes are only a few examples of printed materials.
Receiving commodities into a warehouse is a procedure that must be followed.
The warehouse is in charge of initiating supplies when they first arrive at the site. Materials can be processed in a variety of ways. Materials used in manufacturing, for example, must be registered and examined for an allowed source and grade (pharmaceutical or medical), although they may or may not require a unique identifier. Make sure you’re familiar with your SOPs.
Starting chemicals used in product formulation must always be checked to ensure that they meet the following requirements:
- It was delivered by a reputable vendor.
- Are in good condition
- For traceability purposes, they are properly tagged and recognized with the supplier’s lot number.
- A unique internal lot number is assigned to them.
- Inventory is kept track of.
- Samples were taken for release testing after they were quarantined.
Some of these substances may degrade when exposed to heat, necessitating storage at specific temperatures or even freezing.