GPM Custom Packing Solutions

GMP CUSTOM PACKAGING AND GMP REPACKING

A&C also provides bespoke GMP packaging and repackaging as a service. We can offer a range of bespoke GMP packaging formats that satisfy EU and FDA packaging regulations.

About GPM Custom Packaging & GPM Repacking

A&C also provides bespoke GMP packaging and repackaging as a service. We can offer a range of bespoke GMP packaging formats that satisfy EU and FDA packaging regulations. For both liquid and powder raw materials, our GMP packaging can be customized to fit the batch-specific container sizes required by our clients. For our clients, A&C can GMP repack ingredients in containers that can be utilized in their manufacturing facilities. One of our several ISO class 8 clean rooms is where we perform all of our GMP repacking.

Packaging formats range from 100 mL to 1,000 L, and include:

Amber and clear glass bottles
Plastic drums HDPE (various formats)
Stainless steel drums (various formats)
Phenolic resin lined steel drums
Single use bioprocess bags
Intermediate bulk containers (IBCs)

GPM Custom Packaging

Batch-specific packaging lowers risk, minimizes the need for testing, and guarantees that the volumes of raw materials are properly distributed for the production of finished drugs. Testing and volumetrics are tailored to the unique needs of the client. This also lowers the cost of raw materials and the time required for retesting because the packaging is particularly made to fit the precise amount of ingredients needed for a customer’s batch.

A&C has many GMP clean rooms and GMP manufacturing facilities around the world, which enables us to work on multiple projects at once. The quality and purity of all of our products are ensured by the completion of product packaging in a GMP clean room environment that is HEPA filtered and complies with ISO Class 8 clean room standards. Every product is supplied in approved wrapping, on approved pallets, or in outer rigid.

Plastic barrels come in a variety of models to suit the needs of the majority of consumers. Because of their purity and ease of cleaning and sterilization, stainless steel drums are commonly utilized in the pharmaceutical business. When it is essential to ship and store materials in the same container, IBC tanks should be used. They can be applied to liquids that are harmful or not.

In addition to standard package sizes, A&C provides custom GMP packaging to better meet our clients’ demands. Many of our clients have been contacting us on a regular basis to custom package different items. Preservatives, binders, lubricants, antioxidants, process solutions, buffers, solvents, and a limited quantity of APIs are among the things that undergo comprehensive testing before being issued to the relevant compendia in line with customer specifications.

A&C’s GMP CUSTOM PACKAGING PROCESS

A&C’s robust GMP custom packaging process consists of various steps, including:

Raw materials sourcing

A&C purchases raw materials from one of our approved suppliers. A strict supplier qualification process and regular audits ensure all our suppliers fully adhere to GMP and GDP guidelines at all times.

Incoming raw material testing

All raw materials enter A&C’s QMS before the ID testing and internal release are performed. We utilize MasterControl – one of the world’s leading Quality Management Systems – to ensure traceability and transparency throughout the entire process.

GMP custom packaging

A&C GMP custom packages the raw materials according to the pack size and format required by the customer. All GMP packaging and repacking is carried out in ISO Class 8 cleanrooms and we offer batch-specific containers ranging from 100 ml to 1,000 litres. A&C is committed to working with sustainable packaging solutions and offers a plastic packaging reduction programme to contribute to the reduction of the carbon footprint.

Sampling

We provide customer-specific sampling plans for every batch, based on customers’ specifications. Once the GMP custom packaging process is completed, A&C provides satellite samples for faster QC qualification and/or tailgate samples with products to ensure efficient incoming material testing.

Testing

Once the raw materials have been GMP packaged, testing is carried out against established protocols of the applicable governing monographs. Additional tests can also be performed as part of the GMP release. A&C has the capability to validate customers’ existing testing protocols or to develop and validate new testing protocols equivalent to compendial tests.

Product release

The last step of our GMP packaging process is the QA release of the final product under full GMP compliance, with documentation and supply chain transparency provided.