Meaning
Pre-established chemical and physical thresholds must be met by every manufactured batch before it can be distributed for commercial sale. The lot release criteria are a set of legal limits that ensure product safety and quality. These parameters are registered with regulatory bodies before manufacturing begins.
Compliance Standard
The National Medical Products Administration and the State Administration for Market Regulation oversee these quality checkpoints for industrial and medical products. Every manufacturing lot must undergo mandatory testing to confirm that the lot release criteria are met. This legal obligation cannot be bypassed or postponed.
The regulatory filings must specify the exact test methods used to confirm these boundaries.
Verification Process
Inspectors from the municipal administration for market regulation review these batch release sheets during annual plant inspections. They trace the physical sample tests back to the raw laboratory logs to ensure that no batch has been released based on fabricated data. The manufacturer must preserve these samples for a specified period after the lot has been sold.
This allows the regulator to conduct independent verification tests.
Enforcement Risk
Releasing a batch that fails to meet the registered lot release criteria violates the PRC Product Quality Law and triggers severe administrative actions. These penalties include confiscation of the illegal earnings and fines up to ten times the value of the products. For foreign-invested enterprises, repetitive failures can lead to the permanent revocation of the production license.
The legal representative of the company can also face personal fines under the revised administrative guidelines.
