The development of medicine and medical devices is highly regulated in Australia and it is essential that every therapeutic goods manufacturer carefully follows and complies with the law. So what are their key responsibilities?
Comply with rules, standards and conditions
There are a number of legislated standards that Lavida Pharmaceuticals and every therapeutic goods manufacturer must follow and their responsibilities include
- Ensuring all correct steps and standards are carried out at every stage of the process
- That all medicine or medical devices conform to the standards set out for them
- That any authorisations or licensing require are obtained
- That all necessary quality control measures are properly employed at every stage of the process
- That preventative action plans are in place to help correct or prevent any issues in the process or making medicine or medicinal devices
An extremely important responsibility for Lavida Pharmaceuticals and every therapeutic goods manufacturer is to ensure that proper record keeping is performed, this involves keeping records of the;
- Materials used to create medicines or medicine devices, including the quantities of materials or ingredients and details of the tests used on the materials
- The control procedure that are in place during the process of creating goods, including any tests or processed used on-site
- The studies and test that show the stability of the product and form the basis for the recommended shelf life and storage conditions of products
All records must be kept for a minimum of twelve months after the expiry of the products that they are related to, if there isn’t an expiry than they must be kept for at least six years.
Products produced by Lavida Pharmaceuticals and any therapeutic goods manufacturer must be produced in batches which can be easily identified. This means that every batch must have an associated batch number and records of the batch must be kept for 12 months after expiry, or six years after completion.
Keeping the TGA informed
There are a number of requirements around keeping the TGA informed, all operations must notify them of any significant changes which could impact on operations either by email or application.
Providing information on quality, safety and efficacy
It is essential that the TGA is kept informed about nay information relating to potential harmful effects of medication, issues with efficacy or anything that would suggest the quality or safety of a product is in question. If there are any concerns than a report should be made, either to recalls, biological or the quality branch. Or a medicine or vaccine defect should be reported.
Changes to processes
If there any changes to the steps involved in creating medicine or medical devices, the change cannot be introduced until a variation application is made to the TGA.
An important responsibility for any therapeutic good manufacturer is to allow inspections, which can include making records available to the TGA or allowing access to their premises and records for inspections.
Inspectors must be made aware of any health or safety requirements at the premises and responsible staff must be appointed to accompany the inspector throughout the inspection.
Post-inspection any recommendations or conditions must be complied with. There are also a great number of licensing requirements and special conditions that operations must be sure they keep on top of in addition to annual fees and payments that must be made to the TGA. Any supplier that is unsure of their responsibilities should contact the TGA and ask any relevant questions. Penalties can apply to those who do not follow the rules and restrictions that are legislated or put in place.