|
Primary Materials
Active ingredients & Excipients identified by a batch number, put in quarantine, sampled and tested for conformity to the established requirements. Only after the analytical release they can be used.
In-Process controls
Reactions checked to confirm the correct course, in conformity to the S.O.P.s
Finished Product
Finished products have to show the quality required for the intended use, in compliance with the authentic pharmacopoeia.
Packaging
The final packaging carried out so that mistakes or cross contamination would be impossible.
Labeling
Labels applied in conformity to the requirements of the authorities and customers.
Delivery
Delivery should be safe and punctual.
Planning
Regular plans of the time of purchase of raw materials and manufacture ensure a just in time approach and availability at all times.
Records
Operation processes drawn up in writing, checked and signed.
instructions
The production process described in detail within the parameter range for all the chemical and physical characteristics. quality specifications indicate the acceptable rang for approval of the product.
Documentation
The relevant documentation such as batch records, certificates of analysis, labels and … recorded.
Design Qualification
New plants and equipment designed specifically for the intended requirements.
Installation Qualification
The procedures followed have to ensure that the functional characteristics of the equipment are preserved.
Operation Qualification
Working instructions for each piece of equipment give descriptions for operation in order to achieve the suitable results.
Calibration
All equipment identified, coded and periodically calibrated for proper performance.
|