Pharmaceutical production process quality assurance system:
(i) personnel production process quality assurance system control system.
(ii) utility engineering control system.
(iii) preparation control system.
(iv) Material control system.
(v) Production process control system.
(vi) Quality inspection control system.
(vii) Documentation control system.
(viii) Validation control system.
(ix) User complaint control system.
Pharmaceutical production is the process of processing raw materials into pharmaceuticals capable of medical use. The process of drug production is usually categorized into the stage of production of raw materials and the stage of production of formulations in which the raw materials are made into certain dosage forms. In addition, for some drugs, the production of pharmaceutical intermediates is also included.
The nature of the drug, its role and its characteristics objectively determines the modern pharmaceutical production has the following characteristics:
1. Mechanization, automation requirements. For drugs, the production staff itself is a source of pollution. Therefore, drug production requires a high degree of mechanization, automation.
2. The production process uses more instruments and equipment, and production equipment has a strong multi-purpose (i.e., for the production of a variety of drugs).
3 strict health requirements for the production of the degree of hygiene and cleanliness of the production car country and the health of the plant will have a greater impact on the quality of medicines, and even between different varieties or a variety of different batches of products for the source of contamination, therefore, the production of medicines on the production of environmental hygiene requirements are very strict, the plant, roads and transportation shall not be polluted to the production of medicines, production personnel, equipment, and packaging of medicines and so on. The production personnel, equipment and packaging of medicines shall not cause pollution to the medicines.
4. Higher requirements for production conditions. Temperature, humidity, air cleanliness and other factors directly affect the quality of drugs, is the production process of drugs need to be strictly controlled.
5. The product has a strict quality baseline requirements, the drugs are not allowed to have such as foreign products, "treatment products", etc., must be in line with the standard of the drug qualified products: eye product a quality problem, usually can not be meal repair. Therefore, the guest on the requirements of the drug production outside the state of zero error rate.
6. The production of the product and its intrinsic quality inspection of the professional industry is strong.
7. There are many production links and the production process is more complex.
8. Usually produce more "three wastes".
9. Higher fixed costs, economies of scale.
10. A wide range of products, specifications, dosage forms.