So we are looking at our drug development pathway and we can take bog standard drug powder dissolve it in water and administer to animals but that isn't good enough for human work.
So in animals we have to do things to conform with Good Laboratory Practice (GLP) but to deliver drugs to humans the standards are even higher and things have to be done to GMP standards.
Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.
All guidelines follow a few basic principles:
So we have to get chemists involved again to formulate your drug into the pill or capsule or as an solution for injection. If you have a water soluble (dissolves in water) drug, like ours then this is easy to formulate but some are like brick dust and difficult to dissolve in anything.
- Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
- Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.
- Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
- Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
- Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
- Operators are trained to carry out and document procedures.
- Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
- Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
- The distribution of the drugs minimizes any risk to their quality.
- A system is available for recalling any batch of drug from sale or supply.
- Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
Once you have drugs in pill form and the ethics in place we are ready to go. Phase I here we come!
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