Pharmaceutical good manufacturing practices

Pharmaceutical manufacturing requires following current good manufacturing practices (cGMPs). Finished dosage forms require adherence to GMP Federal regulations (21 CFR part 211) enforced by FDA. If a firm manufactures active pharmaceutical ingredients (APIs) that are chemicals or proteins made from cells, they must follow GMPs guidelines found in the International Conference on Harmonization Tripartite Guideline Q7 formerly known as Q7A. This GMP guide follows a similar review of systems that FDA follows when an inspection is conducted. The systems that must be in control whether the drug is an API or finished dosage form are the Quality system, Materials system, Facilities and Equipment system, Production system, Packaging and Labelling system and the Laboratory Control system. Another element that must be in control is the use of electronic signatures in these systems. This means that computers controlling manufacturing, record keeping and laboratory equipment must show a complete audit trail with no changes going unrecorded. If different computer systems are interfaced with each other they have to be validated so there are no chances or errors in instructions, batch record documentation, or company-wide procedures (errors or failures cannot go unrecorded or be changed or deleted). Most of these quality assurance controls were derived from the aerospace industry to prevent failures, labeling mix-ups, cross-contamination or out-of-specification results . Now companies are able to use a concept called "quality by design" so there is quality built into a product and that every system is in control before the product is made. Product specifications now can be analyzed with statistical analysis to see if a product's specifications are drifting out of control. A manufacturing process of a pharmaceutical should have all critical steps and in-process testing thought about before commercial scale manufacturing takes place and this is done in the pilot scale or experimental phase of a product's development. Process validation is then done to make sure a product is able to be manufactured consistently with no affect on a product's quality attributes. Pharmaceuticals being manufactured today must be following all these quality controls in order to make a drug with the utmost safety in mind.