When we talk about the pharmaceutical industry and its typical requirements, we commonly refer to regulations related to manufacturing processes such as Production, Quality, and Maintenance, which significantly impact the output product. However, for successful and quality products, it is necessary to focus on major and minor processes, and the warehouse is one of them.

The pharmaceutical industry warehouse is a critical entity that can make or break the entire production process. It can affect the properties and characteristics of different entities stored in it, such as raw materials and packaging materials. For these reasons, and like these, pharma manufacturers pay special attention to the design and quality of warehouses. 

What is a Pharmaceutical Warehouse?

Commonly, a warehouse is a designated and dedicated area for storing goods and materials related to the pharmaceutical manufacturing process. A critical requirement of the pharmaceutical warehouse is its environmental control feature. It is required because many pharma products require specialized conditions to store. Otherwise, pharma products will lose their therapeutic effect or can be damaged. 

Some common pharma products stored in the warehouse include

·         Chemicals and buffers used in manufacturing process and laboratory tests. These chemicals or buffers have specialized characteristics that can only be retained in the warehouse before entering their designated departments.

·         Packaging material used in packaging operations, such as Aluminum Foils, Bottles, Caps, Vials, and Ampoules

·         Raw material used in the manufacturing of pharma products such as actives and excipients

·         Printed materials such as labels, leaf inserts, and different printed instructions

·         Finished pharma products that have completed the manufacturing process and are ready to be dispatched for distribution

Warehouse also requires controlled parameters, including environmental such as temperature and humidity. These parameters are maintained according to product requirements throughout the warehouse operation. It is necessary because temperature and moisture can affect a pharma product's chemical properties, making it useless for patients.

Like other pharma departments and operations, the warehouse must be designed, built, and maintained according to regulatory requirements. Because these regulations are required for products, these bodies also inspect them routinely. They can issue a warning or even shut down operations if any deviation is found.

Importance of warehouses in the pharmaceutical industry

The warehouse in the pharmaceutical department is the highly critical department that serves to preserve vital properties and characteristics of the goods being stored. Below are the reasons for the importance of warehouses in pharma

Preserve properties of final finished products.

The warehouse stores the final finished product and provides storage conditions according to the product requirements. Examples include temperature and humidity that must remain under the limits, or the product will lose efficacy.

This is necessary because, in manufacturing areas, required environmental conditions are readily available. As soon as the product leaves the manufacturing facility, it is possible that the ecological conditions are not satisfactory. 

Additionally, after manufacturing a specific product, it is possible that there is no immediate demand, and it could take time for distribution to reach its end user. Thus, during its transit stage, the warehouse provides necessary storage conditions.

Preserves Packaging Material

Among other products, packaging material is also stored in the warehouse until required and consumed in the packaging process. The warehouse in the pharmaceutical industry provides all the environmental conditions necessary for the safe storage of packaging material. It helps to protect against degradation and chemical change. 

Storing packaging material in the warehouse is necessary because if suitable conditions are not present, it will affect the properties of the packaging material and can fail the packaging process. Affected packaging material also becomes dangerous for packaged products.

For example, if suitable storage conditions are not provided, the sealing process in blistering operations will be affected.

Raw Material Storage

Like pharma products, raw materials also require specified storage conditions, which helps sustain their properties and efficiency. Otherwise, raw materials will lose their properties and affect the performance of the final finished product.

Raw materials can also use the controlled conditions provided in the warehouse for storage. Its main advantage is that controlled conditions are reproducible in the entire warehouse. This becomes important for critical products such as vaccines and biologics, which are costly and require special approvals from regulatory bodies.

Safety

Warehouses in the pharma industry are an effective and proven safety for the stored products in many ways, including the following

· As mentioned in this article, it is easy and effective in the warehouse to provide product-specific requirements such as temperature and humidity

· In a warehouse, the danger of mix-up is prevented by using software systems for material management, such as material entry, labeling, placement, requisition, and outgoing. This increases the efficiency of a warehouse to dispatch required material for the required process

· In a warehouse, it is easy to monitor product movement, I.e., incoming material, moving between different department or placement locations, and outgoing. This helps in solving problems such as wastage, loss, mix-up, and theft

Regulatory Requirements

As mentioned in this article, the regulatory body also has warehouse guidelines, and the pharma manufacturer must follow these guidelines. 

Adhering to these guidelines helps to acquire regulatory body accreditation.

Some common regulatory guidelines for managing a warehouse in the pharma industry include the following

· United States Pharmacopeia – USP <659> “Packaging and Storage Requirements”

· Japanese Pharmacopeia 

· EMA GUIDELINE on "Declaration Of Storage Conditions" 

· European Pharmacopoeia (Pharm.Eur.) gives some hints in chapter 1.2 

Key features of a pharmaceutical warehouse

The function and purpose of a warehouse in the pharmaceutical industry differs from a warehouse in other sectors because it stores materials directly consumed by humans, which can significantly impact human life. For this reason, the design consideration and requirements of a pharma warehouse is different from those of others

Below are some key warehouse features used in a typical pharma organization. However, please consult relevant guidelines and experts for specific design guidelines

Cleanliness

The warehouse in the Pharma industry must be cleaned and free from dust or foreign particles. It helps to achieve sterility and efficacy of the final finished product.

It can be achieved using an appropriate ventilation system through a HAVC system and must be installed with adequate filtering systems.

Temperature and Humidity

Temperature and humidity affect pharma products the most, and all pharma departments are maintained at standard temperature levels, and the warehouse is not exceptional. The temperature of the warehouse must be maintained at specified levels to prevent changes in the characteristics of stored materials.

The United States Pharmacopeia < USP 659> "Packaging and Storage requirements" defines a given product's essential temperature and humidity requirements. It describes two methods for temperature and humidity, i.e., item label and USP guidelines

An article must be stored according to the label's instruction, identified during stability studies

When no specific instructions are specified, make sure that

Articles must be protected from moisture, freezing, and heat through proper arrangements and measures

Standard Range of article storage includes the following

· Raw materials: 15 – 30°C

Range of humidity according to the following

· 20 –80

Divide your warehouse

During the design phase, divide your warehouse into zones. It helps to effectively divide resources, control environmental parameters, and perform monitoring.

The area must be divided according to the functions it –performs and material flow.

Some standard zones in the Pharma warehouse include the following. 

Loading / unloading area

The loading/unloading area is a warehouse's entry and exit point. Effective designing of this area prevents obstacles or setbacks to slow or delay the loading/unloading of trucks.

Some factors to consider include

·         What is the volume of your organization's material flow?

·         Time of arrival and departure of trucks

Receiving zone

It is the entry point of materials in the warehouse facility. From the loading/unloading area, the material is moved into receiving for necessary processes such as record entry, inspection, and quality tests.

Adequate resources should be dedicated to speed up the process and for accurate data entry and inspection.

Storage area

This is the leading warehouse area where all materials or items are stored. Commonly, pallets and racks are used to store them. Additionally, areas or spaces must be labeled appropriately to prevent mixing and easy identification.

Picking

In this area, the requisition of materials from different departments is served.

Dispatch

Materials are transferred to the dispatch area after picking material from the picking zone. From this zone, the material exits and is sent to its final destination.

In addition to mentioned above, some general consideration includes the following.

A backup power supply must be provided to maintain area requirements. If not supplied, it can degrade materials and even destroy several batches or lots in the event of a power breakdown.

The warehouse roof must be reinforced to prevent damage due to utility equipment or environmental factors, such as rain or strong wind.

Installing PVC air curtains at areas where frequent opening and closing of doors occurs due to personnel movement to prevent contamination from outside air.

Arrangements of firefighting mechanisms to deal with the danger of fire. Because it is expected that chemicals are flammable and can cause a fire in the warehouse.

Alert or alarm system for temperature and humidity. If the temperature reaches out of Range, an alarm should be generated, alerting the concerned personnel, such as the area supervisor or maintenance, to take precautionary steps.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.