Pharmaceutical Contract Packaging

Contract packaging has opened a new horizon in the pharma business and is offering tremendous opportunities to both contractors and pharma product owners. More and more pharmaceutical product manufacturers are considering this option, specifically those who can’t afford to develop a manufacturing site or are tackling higher production requirements.

What is a contract packaging?

When another company performs the packaging (filling, seal, and labeling) process on behalf of the original pharma product owner, it is called contact packaging. The packaging can include all types, such as primary, secondary, and tertiary. Although these contractors have well-established facilities, the pharma product manufacturer is responsible for ensuring quality and safety in the final packaged product.

Contract packaging is gaining momentum rapidly due to the advantages it offers. It helps pharma product manufacturers to manage their packaging operations that can be affected by different market constraints

The contractor is responsible for fulfilling all the operational, regulatory, sourcing, and quality requirements for packaging operations, such as machinery, environment, and quality department. Regulatory bodies also inspect these contractors, as they do with original pharma product manufacturers. 

Pharma manufacturers can outsource their packaging operation for all types, including Vial/ampoules, Bottles, Blisters, and others commonly used in the pharma industry, depending upon the facilities that contractors have.

How to select a packaging contractor for your applications

Selecting an ideal pharma contract packer is critical to the success of pharma product owners and must be done wisely.

Let's discuss some valuable factors when selecting a pharma contract packager. 

What is their capacity?

Capacity is the ability of a packaging contractor to produce the desired output levels, and it is the function of available resources in its manufacturing plant,  and includes  equipment, available area, human workforce, quality-related facilities, and many others. 

When selecting a packaging contractor for your organization, is it necessary to determine the capacity of contractors so as not to delay market demands. The contractor must be able to fulfill your needs on time with the highest quality standard. This becomes challenging for the contractor when their clients increase, and they face problems completing orders for multiple clients. 

Some things to consider in packaging contractors when analyzing their capacity requirements include the following.

• Can the packaging contractor run and manage multiple shifts with the same resources? - it helps the pharma product owner manage its market orders in times of high demand and when it plans to market new products.

• Can the pharma contractor dedicate necessary human resources (especially quality and maintenance) during packaging operations? It helps maintain quality in the packaged product with timely delivery.

• Is the contractor able to maintain alternative equipment - it helps to continue production in case there is a significant breakdown or when demands are high? 

The factors mentioned above and others are essential to look for when selecting a pharma contractor and helping a product owner get business targets. 

Regulatory considerations 

The pharma packaging contractor is bound to follow regulatory requirements, just like the product owner. It is responsible for managing all packaging operations under the regulatory guidelines. 

Making arrangements to fulfill regulatory requirements is a resourceful, time-consuming, and complicated activity. It requires an organization to adopt a multifaceted strategy to meet regulatory guidelines. A pharma contractor that can satisfy these guidelines relieves the pharma product owner of a hefty and complicated process.

When selecting a pharma contract packaging, choosing a contractor skilled in maintaining regulatory guidelines is necessary. The pharma contractor must have a dedicated team (like the quality department) responsible for ensuring packaging operations for all clients according to local regulatory regulations, such as Current Good Manufacturing Practice - cGMP. 

Specifically, when starting a new contract, the pharma product owner  team or department must devise plans for regulatory approvals and other tasks 

Infrastructure arrangements

Infrastructure is the key element of a packaging contractor's facilities to pack a product, and it goes hand in hand with other requirements.

Some critical elements of pharma contractor infrastructure include but are not limited to 

Storage 

Storage is a fundamental requirement for pharma manufacturing. It is used to store raw and/or finished products. Additionally, specific requirements, such as temperature and humidity, are necessary for product safety and quality. 

It is also used to store raw materials, such as packaging material used in the packaging process.    

When selecting a packaging contractor for your application, consider how well the contractor manages storage. The contractor must provide product-relevant environmental conditions.  

The storage capacity must also be determined and match the product's owner's requirements. 

Machinery

Packaging machinery is an essential element of pharma contract packaging, and it can pass or fail any packaging process. 

The contractor must arrange and maintain high-quality packaging machinery for an efficient contract packaging business. It must be able to pack products without deviations and discrepancies. Additionally, the contractor must implement effective maintenance programs to keep them in optimum condition and help to deliver the product timely.

The packaging machinery must also be compatible with the regulatory regulations to prevent compliance issues. This can be ensured by inspecting different documents, such as maintenance, URS and validation that indicates the equipment health, at the time of the contract approval by the product owner organization.

Logistics

Logistics for the pharma industry mostly moving pharma-finished products at all levels of the supply chain, especially hard-to-reach areas. With the advent of temperature-controlled products, logistics is also adapting to these product requirements by switching to temperature-controlled shipments where required.

When a packaging contractor finishes the packaging operation and it is ready to be delivered, the contractor is also responsible for providing the product to its end-point; for this, the contractor must be able to process shipments with adequate logistics. The contractor must give timely shipment and, when required, temperature-controlled logistics.

Do they have arrangements to provide adequate environmental conditions?

Environmental conditions in the pharma industry significantly impact the product & process and can make or break the product. Providing product & process-specific ecological conditions such as temperature and humidity is necessary.

The packing contractor is bound to provide specific environmental conditions before and during the packaging process, and it is the function of dedicated equipment, such as HVAC.

The HVAC must be selected appropriately, considering the packaging area and product requirement They must also be appropriately maintained to prevent any deviations in environmental conditions.

Why use packaging contractors?

Some reasons that contract packaging can be a good option include

Specialized knowledge and Skills

Pharma packaging contractors work with a diverse range of clients, which gives them the advantage of diverse knowledge and skills gained while working , and each client has its specific requirements.

For example, some clients' requirements could be low temperature; for some, it could be frozen storage. Working with these clients enables contractors to gain valuable and diverse knowledge, which they often use for commercial purposes.

The most significant advantage of a contractor's diverse skills is the ability to solve problems that a product owner faces in its product life cycle. Since the product owner has a limited portfolio could need more skills and knowledge if trapped in an unknown problem.

Reduced Costs

When product owner outsources their packaging operations to contractors, they are relieved of making arrangements for packaging operations, such as area, machine, and environmental conditions. 

When outsourcing packaging operations to the contractor, the product owner doesn't need to procure and install machinery on its premises; validation is also optional. As a result, it could save a considerable amount of money, which can be saved or utilized for other purposes. 

Planning for product success

When a contractor outsources the packaging operations for a product, the product owner is freed from the various intermediate functions, as mentioned earlier. This enables the owner to focus more on planning and making high-level decisions.

The packaging contractor makes low-level decisions, such as component procurement. This allows the product owner to focus more on their business development by increasing market share and developing new products.

What are the FDA guidelines for contract Packaging

The FDA guidelines for contract packaging are mentioned in the document "Contract Manufacturing

Arrangements for Drugs: Quality Agreements Guidance for Industry." This guideline covers the entire manufacturing operations of a pharma organization, including packaging.

Some highlights of these guidelines are mentioned below.

• Every party involved is responsible for cGMP compliance, and if not followed, the drugs are adulterated.

• The owner's quality department is responsible for approving or rejecting drugs.

• The contractor is also responsible for its quality department, including its documentation.

• There shall be a written quality agreement between the product owner and the contract facility to describe cGMP roles, responsibilities, and activities. 

• The quality agreement should include elements as mentioned in this guideline.

• According to these guidelines, the most critical pieces include

                 □  Manufacturing activities

                              ◆ Quality unit activities

                              ◆ Facilities and equipment

                              ◆ Material management

                              ◆ Product specific consideration

                              ◆ Laboratory controls

                              ◆ Documentation

                  ● Change Control Associated With Manufacturing Activities

• Components and their suppliers

• Establishment locations 

• Manufacturing processes 

• Products or product types that use the same production line, equipment train, or facility 

• Testing procedures

• Major manufacturing equipment 

• Shipping methods 

• Lot numbering scheme 

• Container closure systems 

• Tamper evidence features 

• Product Distribution

About the Author:

Muhammad Asim Niazi

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.