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Muhammad Asim Niazi
What are the FDA guidelines for contract packaging
Muhammad Asim Niazi

Freelance Technical Engineering Writer

What are the FDA guidelines for contract packaging

by Muhammad Asim Niazi

October 18, 2024

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 ma...

Read More
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