Here are some examples of PharmOut’s work, case studies and the outcomes we’ve delivered for our clients:
We believe that Good Manufacturing Practices (GMP) is an essential system required for ensuring that healthcare products are consistently produced and controlled according to quality standards. In most these case studies it will be obvious that the quality of the product cannot be tested into the product.
Compliance with these practices brings several benefits:
- Quality Assurance: The main advantage of GMP is that it enhances the quality of products, ensuring that they are consistently produced and controlled according to established standards.
- Risk Reduction: By following GMP guidelines, manufacturers can significantly reduce the risk of product recalls, which can be costly and damage a company’s reputation.
- Consumer Safety: Compliance ensures that the product is safe for consumption or use and that it meets the necessary safety standards. This minimizes risks to the consumer.
- Market Access: Compliance with GMP is often a requirement for distributing products in certain markets. Regulatory agencies, such as the FDA in the United States or the EMA in Europe, may require GMP compliance.
- Competitive Advantage: Companies that adhere to GMP guidelines can distinguish themselves in the market as they can assure customers of the quality and safety of their products.
- Regulatory Compliance: GMP compliance helps a company prepare for unexpected regulatory inspections since the guidelines lay out what inspectors will be looking for.
For the most current and detailed information on GMP compliance, benefits, and case studies, you should refer to the websites of relevant regulatory agencies, the TGA infringement notices always help focus minds and the US FDA published warning letters i.e. 483’s. See PharmOut’s summary of FDA citations relating to drugs, devices, and biologicals.
We share some of our case studies which will help as learnings for others:
Case study about a global corporation seeking medicinal cannabis facility design and engineering consultancy for GMP and EU GMP compliance to meet the medicinal cannabis export market as well as the Australian market. The project involved two facility designs including license applications and architecture, engineering and documentation to meet TGA PIC/S and EU GMP compliance requirements. Read more…
PharmOut regularly contributes to information sharing and training as part of continuous improvement efforts in relation to pharmaceutical, life sciences, medical device manufacturing, the medicinal cannabis industry and veterinary product production. Browse our top 10 blogs for GMP in pharmaceutical manufacturing, exporting and medicinal cannabis.
Based on our experience, if a regulatory agency wishes to join PIC/S, it’s essential that the inspectorate and industry embark on a “joint journey” for the national good.
A large multi-national medical device company asked PharmOut to help respond to the notices of deficiencies from a TGA audit in order to achieve sustainable compliance.
This case study is an example of where PharmOut was approached by a small pharmaceutical company to urgently help fill a Quality Assurance Manager role.
North American companies in the late 1980’s and early 1990’s got the marketing equivalent of a kick in the face from Japanese companies bringing in consumer products that were both low priced AND high quality.
A small Australian company acting as the Australian sponsor for a range of imported sterile medical devices contacted PharmOut after they were hit with a notice from the TGA that their imported products had been tested and were found to be non-sterile. After trips to China it was found that the husband and wife had got a divorce, in the settlement, he got the factory, and she got the Ethylene Oxide sterilization factory. PharmOut assisted finding an alternative sterilizer and validated the process in record time.