The quality of the capsules should meet the requirements for capsules under the Pharmacopoeia General Rules for Preparation.

Any deviation from the predetermined production process, material balance limits, quality standards, inspection methods, operating procedures, etc. shall be recorded immediately on the relevant records of the post and filled in the Deviation Report Form by the personnel

The occurrence of deviation does not necessarily mean that the product will be scrapped or reworked; it is necessary to investigate the deviation, find out the reasons, determine whether the degree of deviation will affect the quality of the product, and then make a decision on the treatment of the product.

Deviation refers to any situation that deviates from the approved procedure (guidance document) or standard. Such as, the inspection results of raw materials or products exceed the standards, the storage of products is abnormal, equipment failures, the results of calibration exceed the standards, and environmental monitoring results exceed the standards, production process abnormalities, and other unexpected deviations from the results of drug-related regulations or approved standards and procedures.

When deviations occur or are predictable in the production process, there is the timely and accurate process standard to effectively control the impact of deviations and appropriate measures should be taken to prevent the recurrence of such deviations.