Blood And Tissue GMP Consultants

Blood & Tissue GMP Consultants

Blood & Tissue GMP Consultantsblood and tissue gmp consultants

Blood and tissue banks provide unique challenges in that they rely heavily on the use of aseptic processing to create a low “bioburden” product out of non-sterile starting material. This is vastly different to other GMP-regulated industries, such as pharmaceuticals and medical devices – and there is an additional complication: the biological material that is derived from the blood and tissue processes is not able to be terminally sterilised as the process would destroy the actual products. In the Blood and Tissue industry it is even more critical than ever to ‘build-in’ quality at every step of a manufacturing process in order to ensure compliance is achieved and there is minimal residual risk to the patient. This system is GMP or Good Manufacturing Practice, which ensures that products are consistently produced to exacting quality standards.

GMP principles are critical in various fields including pharmaceuticals, medical devices, and food manufacturing.

When it comes to blood and tissue-based products, GMP is particularly important due to the following reasons:

  1. Patient Safety: Blood and tissue products are often used in contexts where patient safety is paramount, such as transfusions, transplants, or other therapeutic applications. GMP ensures that these products are safe, free from contaminants, and perform as expected.
  2. Product Quality and Consistency: GMP provides a framework for maintaining consistent product quality. This means that products are manufactured and tested in a consistent way to ensure they meet their specifications and are fit for their intended use.
  3. Regulatory Compliance: Adherence to GMP is a regulatory requirement in many regions. Regulatory authorities may perform inspections to verify compliance with GMP. Businesses that fail to comply with GMP may face regulatory action, including product recalls or even business closure.
  4. Risk Management: GMP includes principles of risk management. This includes assessing and controlling risks associated with the production and use of blood and tissue products. For example, these might be risks associated with contamination or transmission of disease.
  5. Traceability: GMP principles require detailed record-keeping. This means that if a problem is identified with a particular batch of a product, it can be traced back to its source, and any potentially affected products can be identified and handled appropriately.

GMP involves multiple aspects including facility design, employee training, process validation, quality control testing, complaint handling, and more. All these aspects aim to minimize risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Hence, the principles of GMP play a critical role in ensuring the safety and efficacy of blood and tissue products.

Our Blood & Tissue GMP consultants can help you:

  •  Determine which vendors are appropriate to use. Vendor assurance is often stricter than in other disciplines – to ensure the bioburden levels remain within acceptable specifications, a lot of emphasis is placed on the materials and reagents used to process the starting material into its final form.
  • Determine which GMP codes you need to comply with based on where final product is supplied to. PIC/S, the EMA, the US FDA and the Australian TGA all publish regulations that regulate human blood and tissue banks and one or many might apply to your operations depending on the breadth of your operations.
  • Establish a robust, cost effective quality management system that will support your GMP compliance aims. For products derived from and for humans, control and traceability are key to ensuring compliance with the relevant regulatory requirements.
  • Troubleshoot and solve specific GMP compliance issues. This may include conducting a pre-audit to ensure that your site is audit-ready or, if you’ve already had an audit, we can help with reviewing the findings from a regulatory audit to determine the best course of action.

More Information:

Please contact us at one of our offices around the world to discuss your needs.