GMP CUSTOM PACKAGING AND
Another service offered by A&C is custom GMP packaging and repackaging. We are able to provide a variety of custom GMP packaging formats that meet FDA and EU packaging requirements. Our GMP packaging can be tailored to customers’ batch specific container sizes for both liquid and powder raw materials. A&C can GMP repack ingredients for our customers in packaging that is suitable to be used in their production areas. All of our GMP repacking is carried out in one of our multiple ISO class 8 clean room.
Packaging formats range from 100 mL to 1,000 L, and include:
- Glass bottles (clear & amber)
- Plastic drums HDPE (various formats)
- Stainless steel drums (various formats)
- Phenolic resin lined steel drums
- Single use bioprocess bags
- Intermediate bulk containers (IBCs)
The batch-specific packaging reduces risk, reduces testing requirements and ensures that raw material volumes are correctly allocated for finished drug manufacturing. Volumes and testing are designed to meet customers’ specific requirements. This also reduces retesting time and the cost of raw materials, as the packaging provided is specifically designed according to the correct volume of ingredients for a customer’s batch.
With GMP production facilities globally, A&C has numerous GMP clean rooms allowing us to work on a variety of projects simultaneously. Product packaging is completed in a HEPA filtered GMP clean room environment meeting ISO Class 8 clean room standards, which guarantees the quality and purity of all of our products. All products are delivered on approved pallets, or in approved wrapping and/or outer rigid containers.
Plastic drums are available in different models to address the needs of most customers. Stainless steel drums are widely used in the pharmaceutical industry for their purity & ease of cleaning and sterilization. IBC tanks are recommended for use in situations where it is critical to ship and store materials in the same container. They can be used for either hazardous or non-hazardous liquids.
A&C also has standard packaging sizes, but also offers custom GMP packaging to better accommodate the needs of our clients. We have continually been approached by many of our customers to custom package various materials. All items, including preservatives, binders, lubricants, antioxidants, process solutions, buffers, solvents and a select number of APIs, are fully tested and released to the appropriate compendia in line with customer specifications.
Please contact us if you have any custom GMP packaging requirements.
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.
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.
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.