This is actually a good point. Thank you for bringing it up.
Originally Posted by Grozny
The home brewer or UGL needs to have the highest quality materials to begin with. Anyone can follow GMP standards if they have the facility and are willing to be inspected but does the homebrewer know for sure their raw materials (API's) like powders are pure?
Active Pharmaceutical Ingredient: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation,treatment or prevention of disease or to effect the structure and function of the body.
Additionally your point has even more force because I don't know of very many UGL's that are willing to provide Cleaning Validation reports to reglatory inspectors.
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as:
The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.
It is necessary to Validate Cleaning procedures for the following reasons:
a. It is a customer requirement - it ensures the safety and purity of the product.
b. It is a regulatory requirement in Active Pharmaceutical Ingredient product manufacture.
c. It also assures from an internal control and compliance point of view the quality of the process.
The Active Pharmaceutical Ingredient Industry involves (in general) the manufacture of Active Pharmaceutical Ingredients by both chemical and physical means through a series of multiple step processes. Plants or individual pieces of equipment, including ancillary equipment, may be used in multi-product manufacture or dedicated to individual products.
The result of inadequate cleaning procedures is that any of a number of contaminants may be present in the next batch manufactured on the equipment such as:
1. Precursors to the Active Pharmaceutical Ingredient
2. By-products and/or degradation products of the Active Pharmaceutical
3. The previous product
4. Solvents and other materials employed during the manufacturing process.
This is particularly the case where microbial growth may be sustained by the product.
6. Cleaning agents themselves and lubricants